Contraception

Use of combined contraceptive vaginal rings was associated with an increased risk for several types of sexually transmitted infections (STIs), based on data from a pair of studies presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Previous research has shown that the use of a combined contraceptive vaginal ring (CCVR) may promote changes in immunity in the female genital tract by upregulating immune-related genes in the endocervix and immune mediators within the cervicovaginal fluid, wrote Amy Arceneaux, BS, a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, and colleagues.

The infection rates in the female genital tract can vary according to hormones in the local environment and continued safety analysis is needed as the use of CCVR continues to rise, the researchers noted.

In a retrospective chart review, the researchers assessed de-identified data from TriNetX, a patient database, including 30,796 women who received etonogestrel and ethinyl estradiol CCVRs without segesterone and an equal number who were using oral contraceptive pills (OCP) without vaginal hormones. Patients were matched for age, race, and ethnicity.

Overall use of CCVRs was significantly associated with an increased risk for Herpes simplex virus 2 (HSV-2; relative risk [RR], 1.790), acute vaginitis (RR, 1.722), subacute/chronic vaginitis (RR, 1.904), subacute/chronic vulvitis (RR, 1.969), acute vulvitis (RR, 1.894), candidiasis (RR, 1.464), trichomoniasis (RR, 2.162), and pelvic inflammatory disease (RR, 2.984; P < .0005 for all).

By contrast, use of CCVRs was significantly associated with a decreased risk for chlamydia (RR, 0.760; P = .047). No differences in risk appeared for gonorrhea, syphilis, HIV, or anogenital warts between the CCVR and OCP groups.

Another study presented at the meeting, led by Kathleen Karam, BS, also a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, focused on outcomes on vaginal health and infection risk in women who used CCVRs compared with women who did not use hormones.

The study by Ms. Karam and colleagues included de-identified TriNetX data for two cohorts of 274,743 women.

Overall, the researchers found a significantly increased risk for gonorrhea, HSV-2, vaginitis, vulvitis, pelvic inflammatory disease, anogenital warts, and candidiasis in women using CCVR compared with those using no hormonal contraception, while the risk for chlamydia, syphilis, and HIV was decreased in women using CCVR compared with those using no hormonal contraception.

“I was pleasantly surprised by the finding that the group of women using the hormonal contraception vaginal ring had decreased risk for HIV and syphilis infections,” said Kathleen L. Vincent, MD, of the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, and senior author on both studies, in an interview. She hypothesized that the estrogen released from the ring might have contributed to the decreased risk for those infections.

The findings of both studies were limited primarily by the retrospective design, but the results suggest a need for further study of the effect of local hormone delivery on the vaginal mucosa, the researchers wrote.

Although the study population was large, the lack of randomization can allow for differences in the behaviors or risk-taking of the groups, Dr. Vincent said in an interview.

“The fact that there were STIs that were increased and some that were decreased with use of the vaginal ring tells us that there were women with similar behaviors in both groups, or we might have seen STIs only in one group,” she said. “Additional research could be done to look at varying time courses of outcomes after initiation of the vaginal ring or to go more in-depth with matching the groups at baseline based on a history of risky behaviors,” she noted.
 

Data Inform Multipurpose Prevention Technology

Dr. Vincent and her colleague, Richard Pyles, PhD, have a 15-year history of studying vaginal drug and hormone effects on the vaginal mucosa in women and preclinical and cell models. “Based on that work, it was plausible for estrogen to be protective for several types of infections,” she said. The availability of TriNetX allowed the researchers to explore these relationships in a large database of women in the studies presented at the meeting. “We began with a basic science observation in an animal model and grew it into this clinical study because of the available TriNetX system that supported extensive medical record review,” Dr. Pyles noted.

The take-home messages from the current research remain that vaginal rings delivering hormones are indicated only for contraception or birth control, not for protection against STIs or HIV, and women at an increased risk for these infections should protect themselves by using condoms, Dr. Vincent said.

However, “the real clinical implication is for the future for the drugs that we call MPTs or multi-purpose prevention technologies,” Dr. Vincent said.

“This could be a vaginal ring that releases medications for birth control and prevention of HIV or an STI,” she explained.

The findings from the studies presented at the meeting have great potential for an MPT on which Dr. Vincent and Dr. Pyles are working that would provide protection against both HIV and pregnancy. “For HIV prevention, the hormonal vaginal ring components have potential to work synergistically with the HIV prevention drug rather than working against each other, and this could be realized as a need for less HIV prevention drug, and subsequently fewer potential side effects from that drug,” said Dr. Vincent.

The studies received no outside funding. The researchers had no financial conflicts to disclose.

Use of combined contraceptive vaginal rings was associated with an increased risk for several types of sexually transmitted infections (STIs), based on data from a pair of studies presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Previous research has shown that the use of a combined contraceptive vaginal ring (CCVR) may promote changes in immunity in the female genital tract by upregulating immune-related genes in the endocervix and immune mediators within the cervicovaginal fluid, wrote Amy Arceneaux, BS, a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, and colleagues.

The infection rates in the female genital tract can vary according to hormones in the local environment and continued safety analysis is needed as the use of CCVR continues to rise, the researchers noted.

In a retrospective chart review, the researchers assessed de-identified data from TriNetX, a patient database, including 30,796 women who received etonogestrel and ethinyl estradiol CCVRs without segesterone and an equal number who were using oral contraceptive pills (OCP) without vaginal hormones. Patients were matched for age, race, and ethnicity.

Overall use of CCVRs was significantly associated with an increased risk for Herpes simplex virus 2 (HSV-2; relative risk [RR], 1.790), acute vaginitis (RR, 1.722), subacute/chronic vaginitis (RR, 1.904), subacute/chronic vulvitis (RR, 1.969), acute vulvitis (RR, 1.894), candidiasis (RR, 1.464), trichomoniasis (RR, 2.162), and pelvic inflammatory disease (RR, 2.984; P < .0005 for all).

By contrast, use of CCVRs was significantly associated with a decreased risk for chlamydia (RR, 0.760; P = .047). No differences in risk appeared for gonorrhea, syphilis, HIV, or anogenital warts between the CCVR and OCP groups.

Another study presented at the meeting, led by Kathleen Karam, BS, also a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, focused on outcomes on vaginal health and infection risk in women who used CCVRs compared with women who did not use hormones.

The study by Ms. Karam and colleagues included de-identified TriNetX data for two cohorts of 274,743 women.

Overall, the researchers found a significantly increased risk for gonorrhea, HSV-2, vaginitis, vulvitis, pelvic inflammatory disease, anogenital warts, and candidiasis in women using CCVR compared with those using no hormonal contraception, while the risk for chlamydia, syphilis, and HIV was decreased in women using CCVR compared with those using no hormonal contraception.

“I was pleasantly surprised by the finding that the group of women using the hormonal contraception vaginal ring had decreased risk for HIV and syphilis infections,” said Kathleen L. Vincent, MD, of the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, and senior author on both studies, in an interview. She hypothesized that the estrogen released from the ring might have contributed to the decreased risk for those infections.

The findings of both studies were limited primarily by the retrospective design, but the results suggest a need for further study of the effect of local hormone delivery on the vaginal mucosa, the researchers wrote.

Although the study population was large, the lack of randomization can allow for differences in the behaviors or risk-taking of the groups, Dr. Vincent said in an interview.

“The fact that there were STIs that were increased and some that were decreased with use of the vaginal ring tells us that there were women with similar behaviors in both groups, or we might have seen STIs only in one group,” she said. “Additional research could be done to look at varying time courses of outcomes after initiation of the vaginal ring or to go more in-depth with matching the groups at baseline based on a history of risky behaviors,” she noted.
 

Data Inform Multipurpose Prevention Technology

Dr. Vincent and her colleague, Richard Pyles, PhD, have a 15-year history of studying vaginal drug and hormone effects on the vaginal mucosa in women and preclinical and cell models. “Based on that work, it was plausible for estrogen to be protective for several types of infections,” she said. The availability of TriNetX allowed the researchers to explore these relationships in a large database of women in the studies presented at the meeting. “We began with a basic science observation in an animal model and grew it into this clinical study because of the available TriNetX system that supported extensive medical record review,” Dr. Pyles noted.

The take-home messages from the current research remain that vaginal rings delivering hormones are indicated only for contraception or birth control, not for protection against STIs or HIV, and women at an increased risk for these infections should protect themselves by using condoms, Dr. Vincent said.

However, “the real clinical implication is for the future for the drugs that we call MPTs or multi-purpose prevention technologies,” Dr. Vincent said.

“This could be a vaginal ring that releases medications for birth control and prevention of HIV or an STI,” she explained.

The findings from the studies presented at the meeting have great potential for an MPT on which Dr. Vincent and Dr. Pyles are working that would provide protection against both HIV and pregnancy. “For HIV prevention, the hormonal vaginal ring components have potential to work synergistically with the HIV prevention drug rather than working against each other, and this could be realized as a need for less HIV prevention drug, and subsequently fewer potential side effects from that drug,” said Dr. Vincent.

The studies received no outside funding. The researchers had no financial conflicts to disclose.

Use of combined contraceptive vaginal rings was associated with an increased risk for several types of sexually transmitted infections (STIs), based on data from a pair of studies presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Previous research has shown that the use of a combined contraceptive vaginal ring (CCVR) may promote changes in immunity in the female genital tract by upregulating immune-related genes in the endocervix and immune mediators within the cervicovaginal fluid, wrote Amy Arceneaux, BS, a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, and colleagues.

The infection rates in the female genital tract can vary according to hormones in the local environment and continued safety analysis is needed as the use of CCVR continues to rise, the researchers noted.

In a retrospective chart review, the researchers assessed de-identified data from TriNetX, a patient database, including 30,796 women who received etonogestrel and ethinyl estradiol CCVRs without segesterone and an equal number who were using oral contraceptive pills (OCP) without vaginal hormones. Patients were matched for age, race, and ethnicity.

Overall use of CCVRs was significantly associated with an increased risk for Herpes simplex virus 2 (HSV-2; relative risk [RR], 1.790), acute vaginitis (RR, 1.722), subacute/chronic vaginitis (RR, 1.904), subacute/chronic vulvitis (RR, 1.969), acute vulvitis (RR, 1.894), candidiasis (RR, 1.464), trichomoniasis (RR, 2.162), and pelvic inflammatory disease (RR, 2.984; P < .0005 for all).

By contrast, use of CCVRs was significantly associated with a decreased risk for chlamydia (RR, 0.760; P = .047). No differences in risk appeared for gonorrhea, syphilis, HIV, or anogenital warts between the CCVR and OCP groups.

Another study presented at the meeting, led by Kathleen Karam, BS, also a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, focused on outcomes on vaginal health and infection risk in women who used CCVRs compared with women who did not use hormones.

The study by Ms. Karam and colleagues included de-identified TriNetX data for two cohorts of 274,743 women.

Overall, the researchers found a significantly increased risk for gonorrhea, HSV-2, vaginitis, vulvitis, pelvic inflammatory disease, anogenital warts, and candidiasis in women using CCVR compared with those using no hormonal contraception, while the risk for chlamydia, syphilis, and HIV was decreased in women using CCVR compared with those using no hormonal contraception.

“I was pleasantly surprised by the finding that the group of women using the hormonal contraception vaginal ring had decreased risk for HIV and syphilis infections,” said Kathleen L. Vincent, MD, of the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, and senior author on both studies, in an interview. She hypothesized that the estrogen released from the ring might have contributed to the decreased risk for those infections.

The findings of both studies were limited primarily by the retrospective design, but the results suggest a need for further study of the effect of local hormone delivery on the vaginal mucosa, the researchers wrote.

Although the study population was large, the lack of randomization can allow for differences in the behaviors or risk-taking of the groups, Dr. Vincent said in an interview.

“The fact that there were STIs that were increased and some that were decreased with use of the vaginal ring tells us that there were women with similar behaviors in both groups, or we might have seen STIs only in one group,” she said. “Additional research could be done to look at varying time courses of outcomes after initiation of the vaginal ring or to go more in-depth with matching the groups at baseline based on a history of risky behaviors,” she noted.
 

Data Inform Multipurpose Prevention Technology

Dr. Vincent and her colleague, Richard Pyles, PhD, have a 15-year history of studying vaginal drug and hormone effects on the vaginal mucosa in women and preclinical and cell models. “Based on that work, it was plausible for estrogen to be protective for several types of infections,” she said. The availability of TriNetX allowed the researchers to explore these relationships in a large database of women in the studies presented at the meeting. “We began with a basic science observation in an animal model and grew it into this clinical study because of the available TriNetX system that supported extensive medical record review,” Dr. Pyles noted.

The take-home messages from the current research remain that vaginal rings delivering hormones are indicated only for contraception or birth control, not for protection against STIs or HIV, and women at an increased risk for these infections should protect themselves by using condoms, Dr. Vincent said.

However, “the real clinical implication is for the future for the drugs that we call MPTs or multi-purpose prevention technologies,” Dr. Vincent said.

“This could be a vaginal ring that releases medications for birth control and prevention of HIV or an STI,” she explained.

The findings from the studies presented at the meeting have great potential for an MPT on which Dr. Vincent and Dr. Pyles are working that would provide protection against both HIV and pregnancy. “For HIV prevention, the hormonal vaginal ring components have potential to work synergistically with the HIV prevention drug rather than working against each other, and this could be realized as a need for less HIV prevention drug, and subsequently fewer potential side effects from that drug,” said Dr. Vincent.

The studies received no outside funding. The researchers had no financial conflicts to disclose.

Women who used levonorgestrel-releasing intrauterine devices (LG-IUDs) were 22% less likely to have a stroke than those who did not use hormonal contraception, new research suggested.

The Danish study, which included 1.7 million women, also showed no increased risk for intracerebral hemorrhage for those using the IUDs.

“The finding raises the question of whether levonorgestrel, in addition to its contraceptive properties, could have the potential to prevent (ischemic stroke),” wrote corresponding author Tom Skyhøj Olsen, MD, PhD, of Bispebjerg University Hospital, Copenhagen, Denmark, and coauthors.

The research was published online on May 16, 2024, in the journal Stroke.
 

A Big-Picture Look

Commonly used combined hormonal contraceptives that contain both progestins and ethinylestradiol are linked to an increased risk for ischemic stroke. Previous research suggested that progestin-only options, including LG-IUDs, are not associated with elevated risk and may even lower the risk. The IUDs had also been previously associated with lower risk for thromboembolism.

The new study was a large-scale investigation of all reproductive-age women in Denmark that compared stroke risk in those who used the progestin-only IUDs with those who didn’t use hormonal contraception. It also examined the risk for intracerebral hemorrhage, which had not been previously studied.

The historic cohort study drew on several large national databases in Denmark, including the Danish Stroke Registry, to evaluate the interplay between IUD contraception, stroke, and intracerebral hemorrhage. The study looked back at data collected on all nonpregnant Danish women aged 18-49 years who lived in Denmark for some or all of the period between 2004 and 2021.

Mean age of the 1.7 million women in the study was 30 years, and the mean follow-up period was about 7 years. More than 364,700 participants used LG-IUDs.

During the study period, 2916 women had an ischemic stroke, and 367 experienced intracerebral hemorrhage.

Among IUD users, the incidence of stroke was 19.2 per 100,000 person years. For women who didn’t use contraception, the rate was 25.2.

Overall, those who used an IUD had a 22% lower risk for ischemic stroke than those who didn’t (incidence rate ratio [IRR], 0.78; 95% CI, 0.70-0.88).

The incidence of brain bleeds was similar in both groups.

Does Age Matter?

The incidence of stroke did not differ significantly between the three age groups analyzed in the study: Women aged 18-29 years, 30-39 years, and 40-49 years. Incidence rates of intracerebral hemorrhage were similar between age groups 30-39 years and 40-49 years, but the risk was higher for those aged 18-29 years than for those aged 40-49 years (IRR, 4.49; 95% CI, 1.65-12.19).

The researchers urged caution in interpreting the apparent higher risk for brain bleeds in younger women, noting that the overall number of events was low, resulting in wide CIs.

Investigators also found that women who moved to Denmark from non-Western countries had a significantly lower stroke rate than native Danes. Incidence rates of intracerebral hemorrhage were not affected by country of origin.

The research team noted that they had only indirect information about women’s stroke risk factors including diabetes, high blood pressure, and migraine and had no information about smoking, alcohol consumption, and body mass index.

“Regarding a possible potential for stroke prevention, our study cannot stand alone and requires confirmation in further research. Even though the incidence rate for [ischemic stroke] and [intracerebral hemorrhage] did not significantly change after adjustment for various factors, bias…cannot be fully ruled out,” the researchers wrote.

The study was funded by the Aase og Ejnar Danielsens Fond and Familien Hede Nielsens Fond. The authors reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Women who used levonorgestrel-releasing intrauterine devices (LG-IUDs) were 22% less likely to have a stroke than those who did not use hormonal contraception, new research suggested.

The Danish study, which included 1.7 million women, also showed no increased risk for intracerebral hemorrhage for those using the IUDs.

“The finding raises the question of whether levonorgestrel, in addition to its contraceptive properties, could have the potential to prevent (ischemic stroke),” wrote corresponding author Tom Skyhøj Olsen, MD, PhD, of Bispebjerg University Hospital, Copenhagen, Denmark, and coauthors.

The research was published online on May 16, 2024, in the journal Stroke.
 

A Big-Picture Look

Commonly used combined hormonal contraceptives that contain both progestins and ethinylestradiol are linked to an increased risk for ischemic stroke. Previous research suggested that progestin-only options, including LG-IUDs, are not associated with elevated risk and may even lower the risk. The IUDs had also been previously associated with lower risk for thromboembolism.

The new study was a large-scale investigation of all reproductive-age women in Denmark that compared stroke risk in those who used the progestin-only IUDs with those who didn’t use hormonal contraception. It also examined the risk for intracerebral hemorrhage, which had not been previously studied.

The historic cohort study drew on several large national databases in Denmark, including the Danish Stroke Registry, to evaluate the interplay between IUD contraception, stroke, and intracerebral hemorrhage. The study looked back at data collected on all nonpregnant Danish women aged 18-49 years who lived in Denmark for some or all of the period between 2004 and 2021.

Mean age of the 1.7 million women in the study was 30 years, and the mean follow-up period was about 7 years. More than 364,700 participants used LG-IUDs.

During the study period, 2916 women had an ischemic stroke, and 367 experienced intracerebral hemorrhage.

Among IUD users, the incidence of stroke was 19.2 per 100,000 person years. For women who didn’t use contraception, the rate was 25.2.

Overall, those who used an IUD had a 22% lower risk for ischemic stroke than those who didn’t (incidence rate ratio [IRR], 0.78; 95% CI, 0.70-0.88).

The incidence of brain bleeds was similar in both groups.

Does Age Matter?

The incidence of stroke did not differ significantly between the three age groups analyzed in the study: Women aged 18-29 years, 30-39 years, and 40-49 years. Incidence rates of intracerebral hemorrhage were similar between age groups 30-39 years and 40-49 years, but the risk was higher for those aged 18-29 years than for those aged 40-49 years (IRR, 4.49; 95% CI, 1.65-12.19).

The researchers urged caution in interpreting the apparent higher risk for brain bleeds in younger women, noting that the overall number of events was low, resulting in wide CIs.

Investigators also found that women who moved to Denmark from non-Western countries had a significantly lower stroke rate than native Danes. Incidence rates of intracerebral hemorrhage were not affected by country of origin.

The research team noted that they had only indirect information about women’s stroke risk factors including diabetes, high blood pressure, and migraine and had no information about smoking, alcohol consumption, and body mass index.

“Regarding a possible potential for stroke prevention, our study cannot stand alone and requires confirmation in further research. Even though the incidence rate for [ischemic stroke] and [intracerebral hemorrhage] did not significantly change after adjustment for various factors, bias…cannot be fully ruled out,” the researchers wrote.

The study was funded by the Aase og Ejnar Danielsens Fond and Familien Hede Nielsens Fond. The authors reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Women who used levonorgestrel-releasing intrauterine devices (LG-IUDs) were 22% less likely to have a stroke than those who did not use hormonal contraception, new research suggested.

The Danish study, which included 1.7 million women, also showed no increased risk for intracerebral hemorrhage for those using the IUDs.

“The finding raises the question of whether levonorgestrel, in addition to its contraceptive properties, could have the potential to prevent (ischemic stroke),” wrote corresponding author Tom Skyhøj Olsen, MD, PhD, of Bispebjerg University Hospital, Copenhagen, Denmark, and coauthors.

The research was published online on May 16, 2024, in the journal Stroke.
 

A Big-Picture Look

Commonly used combined hormonal contraceptives that contain both progestins and ethinylestradiol are linked to an increased risk for ischemic stroke. Previous research suggested that progestin-only options, including LG-IUDs, are not associated with elevated risk and may even lower the risk. The IUDs had also been previously associated with lower risk for thromboembolism.

The new study was a large-scale investigation of all reproductive-age women in Denmark that compared stroke risk in those who used the progestin-only IUDs with those who didn’t use hormonal contraception. It also examined the risk for intracerebral hemorrhage, which had not been previously studied.

The historic cohort study drew on several large national databases in Denmark, including the Danish Stroke Registry, to evaluate the interplay between IUD contraception, stroke, and intracerebral hemorrhage. The study looked back at data collected on all nonpregnant Danish women aged 18-49 years who lived in Denmark for some or all of the period between 2004 and 2021.

Mean age of the 1.7 million women in the study was 30 years, and the mean follow-up period was about 7 years. More than 364,700 participants used LG-IUDs.

During the study period, 2916 women had an ischemic stroke, and 367 experienced intracerebral hemorrhage.

Among IUD users, the incidence of stroke was 19.2 per 100,000 person years. For women who didn’t use contraception, the rate was 25.2.

Overall, those who used an IUD had a 22% lower risk for ischemic stroke than those who didn’t (incidence rate ratio [IRR], 0.78; 95% CI, 0.70-0.88).

The incidence of brain bleeds was similar in both groups.

Does Age Matter?

The incidence of stroke did not differ significantly between the three age groups analyzed in the study: Women aged 18-29 years, 30-39 years, and 40-49 years. Incidence rates of intracerebral hemorrhage were similar between age groups 30-39 years and 40-49 years, but the risk was higher for those aged 18-29 years than for those aged 40-49 years (IRR, 4.49; 95% CI, 1.65-12.19).

The researchers urged caution in interpreting the apparent higher risk for brain bleeds in younger women, noting that the overall number of events was low, resulting in wide CIs.

Investigators also found that women who moved to Denmark from non-Western countries had a significantly lower stroke rate than native Danes. Incidence rates of intracerebral hemorrhage were not affected by country of origin.

The research team noted that they had only indirect information about women’s stroke risk factors including diabetes, high blood pressure, and migraine and had no information about smoking, alcohol consumption, and body mass index.

“Regarding a possible potential for stroke prevention, our study cannot stand alone and requires confirmation in further research. Even though the incidence rate for [ischemic stroke] and [intracerebral hemorrhage] did not significantly change after adjustment for various factors, bias…cannot be fully ruled out,” the researchers wrote.

The study was funded by the Aase og Ejnar Danielsens Fond and Familien Hede Nielsens Fond. The authors reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

BOSTON — An investigational male contraceptive gel suppresses sperm more rapidly than previous products in development, new data suggested.

The product, 8 mg segesterone acetate (Nestorone) combined with 74 mg testosterone (“NesT”) is a gel that a man applies daily to both shoulders. The progesterone blocks spermatogenesis, and the testosterone restores blood levels to maintain sexual function. It is under development by the National Institute of Child Health and Human Development (NICHD) in collaboration with the Population Council, the Los Angeles Biomedical Research Institute, and the University of Washington School of Medicine.

Currently, the only available male contraceptives are vasectomy, which isn’t easily reversible, and condoms, which have a high failure rate. Previous attempts to develop a “male pill” have been unsuccessful for a variety of reasons, but so far, this product appears effective and safe, Diana Blithe, PhD, chief of the Contraceptive Development Program at NICHD, said at a press briefing held on June 2, 2024, during the annual meeting of the Endocrine Society.

“It’s been a long time coming. … Men need and want more contraceptive options such as an effective reversible method,” she told this news organization.

New phase 2b data show that among 222 couples in which the man initially had normal (> 15 million/mL) sperm counts, the median time to suppression (< 1 million/mL) was less than 8 weeks with NesT compared with 9-15 weeks seen in previous trials of injected male hormonal contraceptives. Nearly all (86%) had achieved suppression by 15 weeks.

After two consecutive counts of < 1 million/mL, the couples entered the trial’s ongoing 2-year efficacy phase. There have been no major safety concerns thus far, but “we need more data,” Dr. Blithe noted.

Asked to comment, session moderator Frances Hayes, MBBCh, associate clinical chief of the Division of Reproductive Endocrinology at Massachusetts General Hospital, Boston, said, “certainly, I think it’s a big advance on what we have so far. … I think it’s showing great promise.”

Dr. Hayes did caution, though, that “with real-world use, daily application of a gel might be a bit more challenging than taking an injection…an injection is more consistent. With a gel, patients might forget or shower it off. But I don’t think 1 day of interruption would be a significant thing.”

Transference of the topical to a partner or a child is another potential concern, Dr. Hayes noted, although this is true of current testosterone gel products as well. During the briefing, Dr. Blithe said that this issue is why the product is recommended to be placed on the upper arms rather than the abdomen or another spot more likely to come into contact with another person. Also, in the trial, men were instructed to wear shirts during intercourse.

Regarding the rapidity of sperm suppression, Dr. Hayes said, “It’s surprising. It looks great as a reversible contraceptive. … Normally, you think of the life cycle of the sperm being about 72 days. So to see 50% suppression by 8 weeks, and then 85%-90% by 15 weeks, that’s very rapid. It may be that the progesterone that they’re using is very potent. Progestins can have some negative effects on lipids and mood. We didn’t really see the safety data in this presentation. So that will be interesting to see.”

During the briefing, Dr. Blithe said that the phase 2b trial is expected to finish by the end of this year, and in the meantime, the researchers are communicating with the US Food and Drug Administration about the design of a phase 3 trial because this is an unprecedented area. “They don’t have guidelines yet. They’ll need to develop them first.”

Dr. Blithe has been the NICHD principal investigator on cooperative research and development agreements with HRA Pharma and Daré Bioscience. Dr. Hayes had no disclosures.

A version of this article appeared on Medscape.com .

BOSTON — An investigational male contraceptive gel suppresses sperm more rapidly than previous products in development, new data suggested.

The product, 8 mg segesterone acetate (Nestorone) combined with 74 mg testosterone (“NesT”) is a gel that a man applies daily to both shoulders. The progesterone blocks spermatogenesis, and the testosterone restores blood levels to maintain sexual function. It is under development by the National Institute of Child Health and Human Development (NICHD) in collaboration with the Population Council, the Los Angeles Biomedical Research Institute, and the University of Washington School of Medicine.

Currently, the only available male contraceptives are vasectomy, which isn’t easily reversible, and condoms, which have a high failure rate. Previous attempts to develop a “male pill” have been unsuccessful for a variety of reasons, but so far, this product appears effective and safe, Diana Blithe, PhD, chief of the Contraceptive Development Program at NICHD, said at a press briefing held on June 2, 2024, during the annual meeting of the Endocrine Society.

“It’s been a long time coming. … Men need and want more contraceptive options such as an effective reversible method,” she told this news organization.

New phase 2b data show that among 222 couples in which the man initially had normal (> 15 million/mL) sperm counts, the median time to suppression (< 1 million/mL) was less than 8 weeks with NesT compared with 9-15 weeks seen in previous trials of injected male hormonal contraceptives. Nearly all (86%) had achieved suppression by 15 weeks.

After two consecutive counts of < 1 million/mL, the couples entered the trial’s ongoing 2-year efficacy phase. There have been no major safety concerns thus far, but “we need more data,” Dr. Blithe noted.

Asked to comment, session moderator Frances Hayes, MBBCh, associate clinical chief of the Division of Reproductive Endocrinology at Massachusetts General Hospital, Boston, said, “certainly, I think it’s a big advance on what we have so far. … I think it’s showing great promise.”

Dr. Hayes did caution, though, that “with real-world use, daily application of a gel might be a bit more challenging than taking an injection…an injection is more consistent. With a gel, patients might forget or shower it off. But I don’t think 1 day of interruption would be a significant thing.”

Transference of the topical to a partner or a child is another potential concern, Dr. Hayes noted, although this is true of current testosterone gel products as well. During the briefing, Dr. Blithe said that this issue is why the product is recommended to be placed on the upper arms rather than the abdomen or another spot more likely to come into contact with another person. Also, in the trial, men were instructed to wear shirts during intercourse.

Regarding the rapidity of sperm suppression, Dr. Hayes said, “It’s surprising. It looks great as a reversible contraceptive. … Normally, you think of the life cycle of the sperm being about 72 days. So to see 50% suppression by 8 weeks, and then 85%-90% by 15 weeks, that’s very rapid. It may be that the progesterone that they’re using is very potent. Progestins can have some negative effects on lipids and mood. We didn’t really see the safety data in this presentation. So that will be interesting to see.”

During the briefing, Dr. Blithe said that the phase 2b trial is expected to finish by the end of this year, and in the meantime, the researchers are communicating with the US Food and Drug Administration about the design of a phase 3 trial because this is an unprecedented area. “They don’t have guidelines yet. They’ll need to develop them first.”

Dr. Blithe has been the NICHD principal investigator on cooperative research and development agreements with HRA Pharma and Daré Bioscience. Dr. Hayes had no disclosures.

A version of this article appeared on Medscape.com .

BOSTON — An investigational male contraceptive gel suppresses sperm more rapidly than previous products in development, new data suggested.

The product, 8 mg segesterone acetate (Nestorone) combined with 74 mg testosterone (“NesT”) is a gel that a man applies daily to both shoulders. The progesterone blocks spermatogenesis, and the testosterone restores blood levels to maintain sexual function. It is under development by the National Institute of Child Health and Human Development (NICHD) in collaboration with the Population Council, the Los Angeles Biomedical Research Institute, and the University of Washington School of Medicine.

Currently, the only available male contraceptives are vasectomy, which isn’t easily reversible, and condoms, which have a high failure rate. Previous attempts to develop a “male pill” have been unsuccessful for a variety of reasons, but so far, this product appears effective and safe, Diana Blithe, PhD, chief of the Contraceptive Development Program at NICHD, said at a press briefing held on June 2, 2024, during the annual meeting of the Endocrine Society.

“It’s been a long time coming. … Men need and want more contraceptive options such as an effective reversible method,” she told this news organization.

New phase 2b data show that among 222 couples in which the man initially had normal (> 15 million/mL) sperm counts, the median time to suppression (< 1 million/mL) was less than 8 weeks with NesT compared with 9-15 weeks seen in previous trials of injected male hormonal contraceptives. Nearly all (86%) had achieved suppression by 15 weeks.

After two consecutive counts of < 1 million/mL, the couples entered the trial’s ongoing 2-year efficacy phase. There have been no major safety concerns thus far, but “we need more data,” Dr. Blithe noted.

Asked to comment, session moderator Frances Hayes, MBBCh, associate clinical chief of the Division of Reproductive Endocrinology at Massachusetts General Hospital, Boston, said, “certainly, I think it’s a big advance on what we have so far. … I think it’s showing great promise.”

Dr. Hayes did caution, though, that “with real-world use, daily application of a gel might be a bit more challenging than taking an injection…an injection is more consistent. With a gel, patients might forget or shower it off. But I don’t think 1 day of interruption would be a significant thing.”

Transference of the topical to a partner or a child is another potential concern, Dr. Hayes noted, although this is true of current testosterone gel products as well. During the briefing, Dr. Blithe said that this issue is why the product is recommended to be placed on the upper arms rather than the abdomen or another spot more likely to come into contact with another person. Also, in the trial, men were instructed to wear shirts during intercourse.

Regarding the rapidity of sperm suppression, Dr. Hayes said, “It’s surprising. It looks great as a reversible contraceptive. … Normally, you think of the life cycle of the sperm being about 72 days. So to see 50% suppression by 8 weeks, and then 85%-90% by 15 weeks, that’s very rapid. It may be that the progesterone that they’re using is very potent. Progestins can have some negative effects on lipids and mood. We didn’t really see the safety data in this presentation. So that will be interesting to see.”

During the briefing, Dr. Blithe said that the phase 2b trial is expected to finish by the end of this year, and in the meantime, the researchers are communicating with the US Food and Drug Administration about the design of a phase 3 trial because this is an unprecedented area. “They don’t have guidelines yet. They’ll need to develop them first.”

Dr. Blithe has been the NICHD principal investigator on cooperative research and development agreements with HRA Pharma and Daré Bioscience. Dr. Hayes had no disclosures.

A version of this article appeared on Medscape.com .

TOPLINE:

Investigators found that the use of oral contraceptives (OCs) may be associated with an increased risk for frontal fibrosing alopecia (FFA) in women with a common variant in the CYP1B1 gene.

METHODOLOGY:

• OC use has been considered a possible factor behind the increased incidence of FFA because it was first documented in 1994, and a recent genome-wide association study of FFA identified a signal for an association with a variant in CYP1B1.
• The same researchers conducted a gene-environment interaction study with a case-control design involving 489 White female patients (mean age, 65.8 years) with FFA and 34,254 controls, matched for age and genetic ancestry.
• Data were collected from July 2015 to September 2017 and analyzed from October 2022 to December 2023.
• The study aimed to investigate the modulatory effect of OC use on the CYP1B1 variant’s impact on FFA risk, using logistic regression models for analysis.

TAKEAWAY:

• The use of OCs was associated with a 1.9 times greater risk for FFA in individuals with the specific CYP1B1 genetic variant, but there was no association among those with no history of OC use.
• The study suggests a significant gene-environment interaction, indicating that OC use may influence FFA risk in genetically predisposed individuals.

IN PRACTICE:

“This gene-environment interaction analysis suggests that the protective effect of the CYPIB1 missense variant on FFA risk might be mediated by exposure” to OCs, the authors wrote. The study, they added, “underscores the importance of considering genetic predispositions and environmental factors, such as oral contraceptive use, in understanding and managing frontal fibrosing alopecia.”

[embed:render:related:node:268676]

SOURCE:

Tuntas Rayinda, MD, MSc, PhD, of St. John’s Institute of Dermatology, King’s College London, led the study, which was published online May 29, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s reliance on self-reported OC use may have introduced recall and differences in ascertainment of OC use between patient and control groups and could have affected the study’s findings. The study also did not collect information on the type of OC used, which could have influenced the observed interaction.

DISCLOSURES:

The study was supported by the British Skin Foundation Young Investigator Award. One investigator reported being a subinvestigator on an alopecia areata study funded by Pfizer. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

TOPLINE:

Investigators found that the use of oral contraceptives (OCs) may be associated with an increased risk for frontal fibrosing alopecia (FFA) in women with a common variant in the CYP1B1 gene.

METHODOLOGY:

• OC use has been considered a possible factor behind the increased incidence of FFA because it was first documented in 1994, and a recent genome-wide association study of FFA identified a signal for an association with a variant in CYP1B1.
• The same researchers conducted a gene-environment interaction study with a case-control design involving 489 White female patients (mean age, 65.8 years) with FFA and 34,254 controls, matched for age and genetic ancestry.
• Data were collected from July 2015 to September 2017 and analyzed from October 2022 to December 2023.
• The study aimed to investigate the modulatory effect of OC use on the CYP1B1 variant’s impact on FFA risk, using logistic regression models for analysis.

TAKEAWAY:

• The use of OCs was associated with a 1.9 times greater risk for FFA in individuals with the specific CYP1B1 genetic variant, but there was no association among those with no history of OC use.
• The study suggests a significant gene-environment interaction, indicating that OC use may influence FFA risk in genetically predisposed individuals.

IN PRACTICE:

“This gene-environment interaction analysis suggests that the protective effect of the CYPIB1 missense variant on FFA risk might be mediated by exposure” to OCs, the authors wrote. The study, they added, “underscores the importance of considering genetic predispositions and environmental factors, such as oral contraceptive use, in understanding and managing frontal fibrosing alopecia.”

[embed:render:related:node:268676]

SOURCE:

Tuntas Rayinda, MD, MSc, PhD, of St. John’s Institute of Dermatology, King’s College London, led the study, which was published online May 29, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s reliance on self-reported OC use may have introduced recall and differences in ascertainment of OC use between patient and control groups and could have affected the study’s findings. The study also did not collect information on the type of OC used, which could have influenced the observed interaction.

DISCLOSURES:

The study was supported by the British Skin Foundation Young Investigator Award. One investigator reported being a subinvestigator on an alopecia areata study funded by Pfizer. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

TOPLINE:

Investigators found that the use of oral contraceptives (OCs) may be associated with an increased risk for frontal fibrosing alopecia (FFA) in women with a common variant in the CYP1B1 gene.

METHODOLOGY:

• OC use has been considered a possible factor behind the increased incidence of FFA because it was first documented in 1994, and a recent genome-wide association study of FFA identified a signal for an association with a variant in CYP1B1.
• The same researchers conducted a gene-environment interaction study with a case-control design involving 489 White female patients (mean age, 65.8 years) with FFA and 34,254 controls, matched for age and genetic ancestry.
• Data were collected from July 2015 to September 2017 and analyzed from October 2022 to December 2023.
• The study aimed to investigate the modulatory effect of OC use on the CYP1B1 variant’s impact on FFA risk, using logistic regression models for analysis.

TAKEAWAY:

• The use of OCs was associated with a 1.9 times greater risk for FFA in individuals with the specific CYP1B1 genetic variant, but there was no association among those with no history of OC use.
• The study suggests a significant gene-environment interaction, indicating that OC use may influence FFA risk in genetically predisposed individuals.

IN PRACTICE:

“This gene-environment interaction analysis suggests that the protective effect of the CYPIB1 missense variant on FFA risk might be mediated by exposure” to OCs, the authors wrote. The study, they added, “underscores the importance of considering genetic predispositions and environmental factors, such as oral contraceptive use, in understanding and managing frontal fibrosing alopecia.”

[embed:render:related:node:268676]

SOURCE:

Tuntas Rayinda, MD, MSc, PhD, of St. John’s Institute of Dermatology, King’s College London, led the study, which was published online May 29, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s reliance on self-reported OC use may have introduced recall and differences in ascertainment of OC use between patient and control groups and could have affected the study’s findings. The study also did not collect information on the type of OC used, which could have influenced the observed interaction.

DISCLOSURES:

The study was supported by the British Skin Foundation Young Investigator Award. One investigator reported being a subinvestigator on an alopecia areata study funded by Pfizer. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

SAN FRANCISCO — Primary care providers placed contraceptive intrauterine devices (IUDs) incorrectly nearly twice as often as ob.gyn. providers at a single institution, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

“Adequate training for providers regarding proper techniques for IUD insertion is imperative for good clinical practice, patient satisfaction, and effectiveness of the LARC [long-acting reversible contraceptive],” Kerrilyn Hewell, MD, a fourth-year resident ob.gyn. at Southern Illinois University in Springfield, reported. “Primary care providers are often seen for contraception management. Therefore, the significantly higher malpositioned rate indicates the need to implement an enhanced simulation/education curriculum for IUD insertion.”

Kevin Ault, MD, a professor and chair of the Department of Obstetrics and Gynecology at Western Michigan University Homer Stryker M.D. School of Medicine, was not involved in the study but said it was not surprising.

“The reasons for obtaining an ultrasound are not discussed in the abstract, so the primary care physicians may have found more problems by ordering more ultrasounds,” Dr. Ault told this news organization. “The takeaway would be to order an ultrasound if you are unsure of placement of the IUD. Malpositioned IUDs may be at risk for expulsion and women may be at risk for unplanned pregnancy.”

The researchers conducted a retrospective review of all adult women’s ultrasounds from the ob.gyn. department of the Southern Illinois University School of Medicine between 2017 and 2020 in which an IUD was documented. Two physicians certified by the American Institute of Ultrasound in Medicine interpreted the images to determine whether the IUD was positioned correctly.

Among 602 ultrasounds included, 562 of the IUDs were placed by an ob.gyn., and 40 were placed by a primary care provider. Most of the IUDs were properly positioned (82%) while 18% were malpositioned. When the researchers compared positioning by specialty, they found that 30% of the malpositioned IUDs had been placed by primary care providers, compared to 17% of malpositioned IUDs placed by an ob.gyn. (P = .043).

The most common type of malpositioning was placement low in the cervix (40.4%) or low but not in the cervix (25.7%). Other types of malpositioning included a deviated axis, the device being inverted or transverse, the IUD arms being folded, the device being embedded, or the device placed outside the uterus.

Of the 136 IUDs placed by an ob.gyn. resident, 17% were malpositioned. Only 6 IUDs had been placed by a primary care resident, and one was malpositioned. Among midlevel providers, 17% of 78 IUDs placed by an ob.gyn. and 33% (5) of 15 IUDs placed by a primary care provider were malpositioned. Among attending physicians, 18% of the 348 IUDs placed by an ob.gyn. and 30% of the 40 IUDs placed by a primary care provider were malpositioned.

No external funding was noted, and the authors and Dr. Ault had no disclosures.

SAN FRANCISCO — Primary care providers placed contraceptive intrauterine devices (IUDs) incorrectly nearly twice as often as ob.gyn. providers at a single institution, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

“Adequate training for providers regarding proper techniques for IUD insertion is imperative for good clinical practice, patient satisfaction, and effectiveness of the LARC [long-acting reversible contraceptive],” Kerrilyn Hewell, MD, a fourth-year resident ob.gyn. at Southern Illinois University in Springfield, reported. “Primary care providers are often seen for contraception management. Therefore, the significantly higher malpositioned rate indicates the need to implement an enhanced simulation/education curriculum for IUD insertion.”

Kevin Ault, MD, a professor and chair of the Department of Obstetrics and Gynecology at Western Michigan University Homer Stryker M.D. School of Medicine, was not involved in the study but said it was not surprising.

“The reasons for obtaining an ultrasound are not discussed in the abstract, so the primary care physicians may have found more problems by ordering more ultrasounds,” Dr. Ault told this news organization. “The takeaway would be to order an ultrasound if you are unsure of placement of the IUD. Malpositioned IUDs may be at risk for expulsion and women may be at risk for unplanned pregnancy.”

The researchers conducted a retrospective review of all adult women’s ultrasounds from the ob.gyn. department of the Southern Illinois University School of Medicine between 2017 and 2020 in which an IUD was documented. Two physicians certified by the American Institute of Ultrasound in Medicine interpreted the images to determine whether the IUD was positioned correctly.

Among 602 ultrasounds included, 562 of the IUDs were placed by an ob.gyn., and 40 were placed by a primary care provider. Most of the IUDs were properly positioned (82%) while 18% were malpositioned. When the researchers compared positioning by specialty, they found that 30% of the malpositioned IUDs had been placed by primary care providers, compared to 17% of malpositioned IUDs placed by an ob.gyn. (P = .043).

The most common type of malpositioning was placement low in the cervix (40.4%) or low but not in the cervix (25.7%). Other types of malpositioning included a deviated axis, the device being inverted or transverse, the IUD arms being folded, the device being embedded, or the device placed outside the uterus.

Of the 136 IUDs placed by an ob.gyn. resident, 17% were malpositioned. Only 6 IUDs had been placed by a primary care resident, and one was malpositioned. Among midlevel providers, 17% of 78 IUDs placed by an ob.gyn. and 33% (5) of 15 IUDs placed by a primary care provider were malpositioned. Among attending physicians, 18% of the 348 IUDs placed by an ob.gyn. and 30% of the 40 IUDs placed by a primary care provider were malpositioned.

No external funding was noted, and the authors and Dr. Ault had no disclosures.

SAN FRANCISCO — Primary care providers placed contraceptive intrauterine devices (IUDs) incorrectly nearly twice as often as ob.gyn. providers at a single institution, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

“Adequate training for providers regarding proper techniques for IUD insertion is imperative for good clinical practice, patient satisfaction, and effectiveness of the LARC [long-acting reversible contraceptive],” Kerrilyn Hewell, MD, a fourth-year resident ob.gyn. at Southern Illinois University in Springfield, reported. “Primary care providers are often seen for contraception management. Therefore, the significantly higher malpositioned rate indicates the need to implement an enhanced simulation/education curriculum for IUD insertion.”

Kevin Ault, MD, a professor and chair of the Department of Obstetrics and Gynecology at Western Michigan University Homer Stryker M.D. School of Medicine, was not involved in the study but said it was not surprising.

“The reasons for obtaining an ultrasound are not discussed in the abstract, so the primary care physicians may have found more problems by ordering more ultrasounds,” Dr. Ault told this news organization. “The takeaway would be to order an ultrasound if you are unsure of placement of the IUD. Malpositioned IUDs may be at risk for expulsion and women may be at risk for unplanned pregnancy.”

The researchers conducted a retrospective review of all adult women’s ultrasounds from the ob.gyn. department of the Southern Illinois University School of Medicine between 2017 and 2020 in which an IUD was documented. Two physicians certified by the American Institute of Ultrasound in Medicine interpreted the images to determine whether the IUD was positioned correctly.

Among 602 ultrasounds included, 562 of the IUDs were placed by an ob.gyn., and 40 were placed by a primary care provider. Most of the IUDs were properly positioned (82%) while 18% were malpositioned. When the researchers compared positioning by specialty, they found that 30% of the malpositioned IUDs had been placed by primary care providers, compared to 17% of malpositioned IUDs placed by an ob.gyn. (P = .043).

The most common type of malpositioning was placement low in the cervix (40.4%) or low but not in the cervix (25.7%). Other types of malpositioning included a deviated axis, the device being inverted or transverse, the IUD arms being folded, the device being embedded, or the device placed outside the uterus.

Of the 136 IUDs placed by an ob.gyn. resident, 17% were malpositioned. Only 6 IUDs had been placed by a primary care resident, and one was malpositioned. Among midlevel providers, 17% of 78 IUDs placed by an ob.gyn. and 33% (5) of 15 IUDs placed by a primary care provider were malpositioned. Among attending physicians, 18% of the 348 IUDs placed by an ob.gyn. and 30% of the 40 IUDs placed by a primary care provider were malpositioned.

No external funding was noted, and the authors and Dr. Ault had no disclosures.

The number of Americans seeking permanent forms of contraception has surged in the nearly 2 years since the Dobbs v. Jackson Women’s Health Organization Supreme Court decision that overturned a federal right to abortion, according to a study presented on May 5 at the annual meeting of the American Urological Association (AUA) (abstract PD40-03). Several other studies at the conference reported similar findings.

Rates of vasectomy and tubal ligation have increased in states where abortion became illegal after the court’s June 2022 ruling, researchers found. Rates of tubal sterilization had already been higher in states where abortion was illegal compared with those where access to the procedure remained available and was expected to remain so, but the difference widened after the decision. 

“Our study showed trends of increasing utilization of permanent contraception post-Dobbs, with a significant increase in patients less than 30 years old pursuing any type of permanent contraception post-Dobbs,” Jessica N. Schardein, MD, MS, of University of Utah Health in Salt Lake City, told attendees. “Reproductive autonomy is important for people of all genders and may be influenced by legal climate. Understanding the relationship between state-level abortion laws and trends in permanent contraception is crucial for us to determine how to best allocate resources for education and services to ensure reproductive rights for all patients.”

Dr. Schardein told this news organization the increase in vasectomies post-Dobbs was consistent across most states regardless of legal climate, showing that “reproductive health matters to all people,” both women and men.

“We should continue to offer permanent contraception to patients who are not interested in future fertility, regardless of their age or marital status, to ensure reproductive autonomy for those patients,” Dr. Schardein said. “Patients may need increased access to these procedures if the increased rates continue over time.”

Dr. Schardein’s study investigated national trends in the use of permanent contraception before and after the Dobbs ruling. She and her colleagues analyzed data from the Epic Cosmos database of more than 217 million patients from an estimated 27,000 clinics and 1260 hospitals nationwide. The researchers identified all adults who underwent a vasectomy or tubal ligation from July to December 2021 and then from July to December 2022, in the 5 months following the decision.

Among adults aged 18-30 years, rates of vasectomy were 1.59 times higher and rates of tubal ligation were 1.29 times higher after the Dobbs ruling than before it (P < .001). Although overall rates of tubal ligation among single women did not change after Dobbs, rates of vasectomy in single men were 1.13 times higher (P < .001).

States were categorized as not hostile to abortion access (abortion access remained available), hostile (access was restricted or might become illegal), or illegal on the basis of information from the Center for Reproductive Rights. Vasectomies increased in most states, with the biggest gain in Tennessee, where abortions are illegal. 

The increase in vasectomy rates was similar across nonhostile (incidence rate ratio [IRR], 1.43), hostile (IRR, 1.46), and illegal (IRR, 1.41) states (P < .001). Although the rate of increase was similar regardless of legal climate, the rate of vasectomies was higher in hostile and illegal states than in nonhostile states both before and after the Dobbs ruling, according to the researchers.

Rates of tubal ligation did not change as substantially across the United States after Dobbs, remaining unchanged in states hostile to abortion access and rising slightly in nonhostile states (IRR, 1.06) and in states where abortion is now illegal (IRR, 1.12; P < .001 for both).

However, when the researchers looked at tubal ligation in nonhostile states and hostile or illegal states, they found that rates of the procedure were nearly double in the hostile or illegal states both before and after Dobbs, with a bigger increase after Dobbs in illegal states. Tubal ligation rates were 1.85 times higher in illegal states than in nonhostile states after Dobbs, compared with being 1.76 times higher than in nonhostile states before Dobbs.
 

Other Studies Support the Findings 

Another study assessed the change in the volume of vasectomy consultations at six US academic medical centers in the 17 months before and 5 months after Dobbs (abstract PD40-02). The researchers reported that the rate was roughly 7% higher after the ruling than before (143 vs 134 cases per month, respectively). Again, the men seeking vasectomies after Dobbs were younger than those who sought the procedure before Dobbs (median age, 38 vs 39 years; P < .001). Post-Dobbs patients were also significantly more likely to be non-Hispanic White, English-speaking, and privately insured. 

“Younger, childless people are choosing vasectomies as permanent method of birth control,” lead author Kara L. Watts, MD, associate professor of urology at Montefiore Medical Center in Bronx, New York, told attendees. “The impact of this decision is likely to be long-lasting, requiring urologists and medical centers to adjust practice patterns to account for the increased demand.”

Twice as many childless married men underwent vasectomies after Dobbs than before the ruling (11% vs 5%, respectively; P = .001), but substantially more childless single men had the procedure after Dobbs than before it (36% vs 21%; P = .003). Those seeking vasectomies after Dobbs had to wait a median of 8 days longer between consult and procedure (59 vs 51 days pre-Dobbs; P < .001). Several of the same researchers had identified an increase in online searches about vasectomies in the months just after the Dobbs decision.

“We’ve been trying to get men to take more responsibility” for their role in unplanned pregnancies, Ajay K. Nangia, MD, MBBS, professor and vice chair of urology at University of Kansas Medical Center in Overland Park, told this news organization. Dr. Nangia, who helped conduct the study of vasectomy consultations and has spent years on research related to pharmaceutical contraception options for men, said the sudden increase in interest in vasectomies can be ethically fraught. Only 25% of vasectomies can be reversed, and some patients who seek the surgery may not have permanently ruled out having children.

“They’re going into this with their eyes wide open, knowing that it’s not 100% going to be reversible with a vasectomy,” he said. But fear of not having abortion access for their partners is part of their motivation, which creates tension for providers in balancing ethical counseling with the potential paternalism of advising against a vasectomy if they’re not certain that they don’t want children. 

“What happens in that situation, when it’s a political decision making you change your medical decision?” Dr. Nangia said. “I worry about that ethically.”

Dr. Nangia noted that the findings of his study cannot show that the Dobbs decision was the cause of the increase in vasectomies. However, in another abstract from the same session (PD40-01), researchers at The Ohio State University College of Medicine in Columbus presented findings from a survey of 57 men who underwent vasectomies in the preceding 2 years. Those results revealed that abortion access had been a factor among some of the 47% of patients whose procedures were performed after Dobbs. Post-Dobbs patients were significantly more likely to say they sought a vasectomy because of concerns about not being able to get abortion (P = .026) and because they didn’t want “to bring children into the current political climate” (P = .002). 

A study presented on May 6 (abstract MP76-06) involved a retrospective review of all 631 patients who underwent a vasectomy consult at UC San Diego Medical Center from June 2021 to June 2023. More vasectomy consults occurred after the Dobbs decision than before it (56% vs 44%). The gap for vasectomy consults was slightly wider for partnerless patients after vs before Dobbs (58% vs 42%) and substantially larger for childless patients post-Dobbs compared with pre-Dobbs (63% vs 37%). The childless men undergoing vasectomies after Dobbs also were significantly younger than those who had had this procedure before the ruling (mean, 36.4 vs 39.8 years; P <.001). 

“Patients should be counseled on the permanent nature of this procedure, underscoring need for effective and reversible male contraception,” the authors concluded.

Dr. Schardein and Dr. Watts reported no relevant financial conflicts of interest. Dr. Nangia is conducting an idiopathic infertility study with funding from Ferring Pharmaceuticals. None of the studies reported external funding.

A version of this article first appeared on Medscape.com.

The number of Americans seeking permanent forms of contraception has surged in the nearly 2 years since the Dobbs v. Jackson Women’s Health Organization Supreme Court decision that overturned a federal right to abortion, according to a study presented on May 5 at the annual meeting of the American Urological Association (AUA) (abstract PD40-03). Several other studies at the conference reported similar findings.

Rates of vasectomy and tubal ligation have increased in states where abortion became illegal after the court’s June 2022 ruling, researchers found. Rates of tubal sterilization had already been higher in states where abortion was illegal compared with those where access to the procedure remained available and was expected to remain so, but the difference widened after the decision. 

“Our study showed trends of increasing utilization of permanent contraception post-Dobbs, with a significant increase in patients less than 30 years old pursuing any type of permanent contraception post-Dobbs,” Jessica N. Schardein, MD, MS, of University of Utah Health in Salt Lake City, told attendees. “Reproductive autonomy is important for people of all genders and may be influenced by legal climate. Understanding the relationship between state-level abortion laws and trends in permanent contraception is crucial for us to determine how to best allocate resources for education and services to ensure reproductive rights for all patients.”

Dr. Schardein told this news organization the increase in vasectomies post-Dobbs was consistent across most states regardless of legal climate, showing that “reproductive health matters to all people,” both women and men.

“We should continue to offer permanent contraception to patients who are not interested in future fertility, regardless of their age or marital status, to ensure reproductive autonomy for those patients,” Dr. Schardein said. “Patients may need increased access to these procedures if the increased rates continue over time.”

Dr. Schardein’s study investigated national trends in the use of permanent contraception before and after the Dobbs ruling. She and her colleagues analyzed data from the Epic Cosmos database of more than 217 million patients from an estimated 27,000 clinics and 1260 hospitals nationwide. The researchers identified all adults who underwent a vasectomy or tubal ligation from July to December 2021 and then from July to December 2022, in the 5 months following the decision.

Among adults aged 18-30 years, rates of vasectomy were 1.59 times higher and rates of tubal ligation were 1.29 times higher after the Dobbs ruling than before it (P < .001). Although overall rates of tubal ligation among single women did not change after Dobbs, rates of vasectomy in single men were 1.13 times higher (P < .001).

States were categorized as not hostile to abortion access (abortion access remained available), hostile (access was restricted or might become illegal), or illegal on the basis of information from the Center for Reproductive Rights. Vasectomies increased in most states, with the biggest gain in Tennessee, where abortions are illegal. 

The increase in vasectomy rates was similar across nonhostile (incidence rate ratio [IRR], 1.43), hostile (IRR, 1.46), and illegal (IRR, 1.41) states (P < .001). Although the rate of increase was similar regardless of legal climate, the rate of vasectomies was higher in hostile and illegal states than in nonhostile states both before and after the Dobbs ruling, according to the researchers.

Rates of tubal ligation did not change as substantially across the United States after Dobbs, remaining unchanged in states hostile to abortion access and rising slightly in nonhostile states (IRR, 1.06) and in states where abortion is now illegal (IRR, 1.12; P < .001 for both).

However, when the researchers looked at tubal ligation in nonhostile states and hostile or illegal states, they found that rates of the procedure were nearly double in the hostile or illegal states both before and after Dobbs, with a bigger increase after Dobbs in illegal states. Tubal ligation rates were 1.85 times higher in illegal states than in nonhostile states after Dobbs, compared with being 1.76 times higher than in nonhostile states before Dobbs.
 

Other Studies Support the Findings 

Another study assessed the change in the volume of vasectomy consultations at six US academic medical centers in the 17 months before and 5 months after Dobbs (abstract PD40-02). The researchers reported that the rate was roughly 7% higher after the ruling than before (143 vs 134 cases per month, respectively). Again, the men seeking vasectomies after Dobbs were younger than those who sought the procedure before Dobbs (median age, 38 vs 39 years; P < .001). Post-Dobbs patients were also significantly more likely to be non-Hispanic White, English-speaking, and privately insured. 

“Younger, childless people are choosing vasectomies as permanent method of birth control,” lead author Kara L. Watts, MD, associate professor of urology at Montefiore Medical Center in Bronx, New York, told attendees. “The impact of this decision is likely to be long-lasting, requiring urologists and medical centers to adjust practice patterns to account for the increased demand.”

Twice as many childless married men underwent vasectomies after Dobbs than before the ruling (11% vs 5%, respectively; P = .001), but substantially more childless single men had the procedure after Dobbs than before it (36% vs 21%; P = .003). Those seeking vasectomies after Dobbs had to wait a median of 8 days longer between consult and procedure (59 vs 51 days pre-Dobbs; P < .001). Several of the same researchers had identified an increase in online searches about vasectomies in the months just after the Dobbs decision.

“We’ve been trying to get men to take more responsibility” for their role in unplanned pregnancies, Ajay K. Nangia, MD, MBBS, professor and vice chair of urology at University of Kansas Medical Center in Overland Park, told this news organization. Dr. Nangia, who helped conduct the study of vasectomy consultations and has spent years on research related to pharmaceutical contraception options for men, said the sudden increase in interest in vasectomies can be ethically fraught. Only 25% of vasectomies can be reversed, and some patients who seek the surgery may not have permanently ruled out having children.

“They’re going into this with their eyes wide open, knowing that it’s not 100% going to be reversible with a vasectomy,” he said. But fear of not having abortion access for their partners is part of their motivation, which creates tension for providers in balancing ethical counseling with the potential paternalism of advising against a vasectomy if they’re not certain that they don’t want children. 

“What happens in that situation, when it’s a political decision making you change your medical decision?” Dr. Nangia said. “I worry about that ethically.”

Dr. Nangia noted that the findings of his study cannot show that the Dobbs decision was the cause of the increase in vasectomies. However, in another abstract from the same session (PD40-01), researchers at The Ohio State University College of Medicine in Columbus presented findings from a survey of 57 men who underwent vasectomies in the preceding 2 years. Those results revealed that abortion access had been a factor among some of the 47% of patients whose procedures were performed after Dobbs. Post-Dobbs patients were significantly more likely to say they sought a vasectomy because of concerns about not being able to get abortion (P = .026) and because they didn’t want “to bring children into the current political climate” (P = .002). 

A study presented on May 6 (abstract MP76-06) involved a retrospective review of all 631 patients who underwent a vasectomy consult at UC San Diego Medical Center from June 2021 to June 2023. More vasectomy consults occurred after the Dobbs decision than before it (56% vs 44%). The gap for vasectomy consults was slightly wider for partnerless patients after vs before Dobbs (58% vs 42%) and substantially larger for childless patients post-Dobbs compared with pre-Dobbs (63% vs 37%). The childless men undergoing vasectomies after Dobbs also were significantly younger than those who had had this procedure before the ruling (mean, 36.4 vs 39.8 years; P <.001). 

“Patients should be counseled on the permanent nature of this procedure, underscoring need for effective and reversible male contraception,” the authors concluded.

Dr. Schardein and Dr. Watts reported no relevant financial conflicts of interest. Dr. Nangia is conducting an idiopathic infertility study with funding from Ferring Pharmaceuticals. None of the studies reported external funding.

A version of this article first appeared on Medscape.com.

The number of Americans seeking permanent forms of contraception has surged in the nearly 2 years since the Dobbs v. Jackson Women’s Health Organization Supreme Court decision that overturned a federal right to abortion, according to a study presented on May 5 at the annual meeting of the American Urological Association (AUA) (abstract PD40-03). Several other studies at the conference reported similar findings.

Rates of vasectomy and tubal ligation have increased in states where abortion became illegal after the court’s June 2022 ruling, researchers found. Rates of tubal sterilization had already been higher in states where abortion was illegal compared with those where access to the procedure remained available and was expected to remain so, but the difference widened after the decision. 

“Our study showed trends of increasing utilization of permanent contraception post-Dobbs, with a significant increase in patients less than 30 years old pursuing any type of permanent contraception post-Dobbs,” Jessica N. Schardein, MD, MS, of University of Utah Health in Salt Lake City, told attendees. “Reproductive autonomy is important for people of all genders and may be influenced by legal climate. Understanding the relationship between state-level abortion laws and trends in permanent contraception is crucial for us to determine how to best allocate resources for education and services to ensure reproductive rights for all patients.”

Dr. Schardein told this news organization the increase in vasectomies post-Dobbs was consistent across most states regardless of legal climate, showing that “reproductive health matters to all people,” both women and men.

“We should continue to offer permanent contraception to patients who are not interested in future fertility, regardless of their age or marital status, to ensure reproductive autonomy for those patients,” Dr. Schardein said. “Patients may need increased access to these procedures if the increased rates continue over time.”

Dr. Schardein’s study investigated national trends in the use of permanent contraception before and after the Dobbs ruling. She and her colleagues analyzed data from the Epic Cosmos database of more than 217 million patients from an estimated 27,000 clinics and 1260 hospitals nationwide. The researchers identified all adults who underwent a vasectomy or tubal ligation from July to December 2021 and then from July to December 2022, in the 5 months following the decision.

Among adults aged 18-30 years, rates of vasectomy were 1.59 times higher and rates of tubal ligation were 1.29 times higher after the Dobbs ruling than before it (P < .001). Although overall rates of tubal ligation among single women did not change after Dobbs, rates of vasectomy in single men were 1.13 times higher (P < .001).

States were categorized as not hostile to abortion access (abortion access remained available), hostile (access was restricted or might become illegal), or illegal on the basis of information from the Center for Reproductive Rights. Vasectomies increased in most states, with the biggest gain in Tennessee, where abortions are illegal. 

The increase in vasectomy rates was similar across nonhostile (incidence rate ratio [IRR], 1.43), hostile (IRR, 1.46), and illegal (IRR, 1.41) states (P < .001). Although the rate of increase was similar regardless of legal climate, the rate of vasectomies was higher in hostile and illegal states than in nonhostile states both before and after the Dobbs ruling, according to the researchers.

Rates of tubal ligation did not change as substantially across the United States after Dobbs, remaining unchanged in states hostile to abortion access and rising slightly in nonhostile states (IRR, 1.06) and in states where abortion is now illegal (IRR, 1.12; P < .001 for both).

However, when the researchers looked at tubal ligation in nonhostile states and hostile or illegal states, they found that rates of the procedure were nearly double in the hostile or illegal states both before and after Dobbs, with a bigger increase after Dobbs in illegal states. Tubal ligation rates were 1.85 times higher in illegal states than in nonhostile states after Dobbs, compared with being 1.76 times higher than in nonhostile states before Dobbs.
 

Other Studies Support the Findings 

Another study assessed the change in the volume of vasectomy consultations at six US academic medical centers in the 17 months before and 5 months after Dobbs (abstract PD40-02). The researchers reported that the rate was roughly 7% higher after the ruling than before (143 vs 134 cases per month, respectively). Again, the men seeking vasectomies after Dobbs were younger than those who sought the procedure before Dobbs (median age, 38 vs 39 years; P < .001). Post-Dobbs patients were also significantly more likely to be non-Hispanic White, English-speaking, and privately insured. 

“Younger, childless people are choosing vasectomies as permanent method of birth control,” lead author Kara L. Watts, MD, associate professor of urology at Montefiore Medical Center in Bronx, New York, told attendees. “The impact of this decision is likely to be long-lasting, requiring urologists and medical centers to adjust practice patterns to account for the increased demand.”

Twice as many childless married men underwent vasectomies after Dobbs than before the ruling (11% vs 5%, respectively; P = .001), but substantially more childless single men had the procedure after Dobbs than before it (36% vs 21%; P = .003). Those seeking vasectomies after Dobbs had to wait a median of 8 days longer between consult and procedure (59 vs 51 days pre-Dobbs; P < .001). Several of the same researchers had identified an increase in online searches about vasectomies in the months just after the Dobbs decision.

“We’ve been trying to get men to take more responsibility” for their role in unplanned pregnancies, Ajay K. Nangia, MD, MBBS, professor and vice chair of urology at University of Kansas Medical Center in Overland Park, told this news organization. Dr. Nangia, who helped conduct the study of vasectomy consultations and has spent years on research related to pharmaceutical contraception options for men, said the sudden increase in interest in vasectomies can be ethically fraught. Only 25% of vasectomies can be reversed, and some patients who seek the surgery may not have permanently ruled out having children.

“They’re going into this with their eyes wide open, knowing that it’s not 100% going to be reversible with a vasectomy,” he said. But fear of not having abortion access for their partners is part of their motivation, which creates tension for providers in balancing ethical counseling with the potential paternalism of advising against a vasectomy if they’re not certain that they don’t want children. 

“What happens in that situation, when it’s a political decision making you change your medical decision?” Dr. Nangia said. “I worry about that ethically.”

Dr. Nangia noted that the findings of his study cannot show that the Dobbs decision was the cause of the increase in vasectomies. However, in another abstract from the same session (PD40-01), researchers at The Ohio State University College of Medicine in Columbus presented findings from a survey of 57 men who underwent vasectomies in the preceding 2 years. Those results revealed that abortion access had been a factor among some of the 47% of patients whose procedures were performed after Dobbs. Post-Dobbs patients were significantly more likely to say they sought a vasectomy because of concerns about not being able to get abortion (P = .026) and because they didn’t want “to bring children into the current political climate” (P = .002). 

A study presented on May 6 (abstract MP76-06) involved a retrospective review of all 631 patients who underwent a vasectomy consult at UC San Diego Medical Center from June 2021 to June 2023. More vasectomy consults occurred after the Dobbs decision than before it (56% vs 44%). The gap for vasectomy consults was slightly wider for partnerless patients after vs before Dobbs (58% vs 42%) and substantially larger for childless patients post-Dobbs compared with pre-Dobbs (63% vs 37%). The childless men undergoing vasectomies after Dobbs also were significantly younger than those who had had this procedure before the ruling (mean, 36.4 vs 39.8 years; P <.001). 

“Patients should be counseled on the permanent nature of this procedure, underscoring need for effective and reversible male contraception,” the authors concluded.

Dr. Schardein and Dr. Watts reported no relevant financial conflicts of interest. Dr. Nangia is conducting an idiopathic infertility study with funding from Ferring Pharmaceuticals. None of the studies reported external funding.

A version of this article first appeared on Medscape.com.

Claudia* was a charming 27-year-old newlywed. She and her husband wanted to start a family — with one small catch. She had recently gained 30 pounds. During COVID, she and her husband spent 18 months camped out in her parents’ guest room in upstate New York and had eaten their emotions with abandon. They ate when they were happy and ate more when they were sad. They ate when they felt isolated and again when they felt anxious. It didn’t help that her mother was a Culinary Institute–trained amateur chef. They both worked from home and logged long hours on Zoom calls. Because there was no home gym, they replaced their usual fitness club workouts in the city with leisurely strolls around the local lake. When I met her, Claudia categorically refused to entertain the notion of pregnancy until she reached her pre-COVID weight.

At the time, this all seemed quite reasonable to me. We outlined a plan including semaglutide (Wegovy) until she reached her target weight and then a minimum of 2 months off Wegovy prior to conception. We also lined up sessions with a dietitian and trainer and renewed her birth control pill. There was one detail I failed to mention to her: Birth control pills are less effective while on incretin hormones like semaglutide. The reason for my omission is that the medical community at large wasn’t yet aware of this issue. 

About 12 weeks into treatment, Claudia had lost 20 of the 30 pounds. She had canceled several appointments with the trainer and dietitian due to work conflicts. She messaged me over the weekend in a panic. Her period was late, and her pregnancy test was positive.

She had three pressing questions for me:

Q: How had this happened while she had taken the birth control pills faithfully?

A: I answered that the scientific reasons for the decrease in efficacy of birth control pills while on semaglutide medications are threefold: 

• Weight loss can improve menstrual cycle irregularities and improve fertility. In fact, I have been using semaglutide-like medications to treat polycystic ovary syndrome for decades, well before these medications became mainstream.
• The delayed gastric emptying inherent to incretins leads to decreased absorption of birth control pills.
• Finally, while this did not apply to Claudia, no medicine is particularly efficacious if vomited up shortly after taking. Wegovy is known to cause nausea and vomiting in a sizable percentage of patients.

Q: Would she have a healthy pregnancy given the lingering effects of Wegovy?

A: The short answer is: most likely yes. A review of the package insert revealed something fascinating. It was not strictly contraindicated. It advised doctors to weigh the risks and benefits of the medication during pregnancy. Animal studies have shown that semaglutide increases the risk for fetal death, birth defects, and growth issues, but this is probably due to restrictive eating patterns rather than a direct effect of the medication. A recent study of health records of more than 50,000 women with diabetes who had been inadvertently taking these medications in early pregnancy showed no increase in birth defects when compared with women who took insulin.

Q: What would happen to her weight loss efforts?

A: To address her third concern, I tried to offset the risk for rebound weight gain by stopping Wegovy and giving her metformin in the second and third trimesters. Considered a safe medication in pregnancy, metformin is thought to support weight loss, but it proved to be ineffective against the rebound weight gain from stopping Wegovy. Claudia had not resumed regular exercise and quickly fell into the age-old eating-for-two trap. She gained nearly 50 pounds over the course of her pregnancy. 

After a short and unfulfilling attempt at nursing, Claudia restarted Wegovy, this time in conjunction with a Mediterranean meal plan and regular sessions at a fitness club. After losing the pregnancy weight, she has been able to successfully maintain her ideal body weight for the past year, and her baby is perfectly healthy and beautiful. 

*Patient’s name changed. 

A version of this article appeared on Medscape.com.

Claudia* was a charming 27-year-old newlywed. She and her husband wanted to start a family — with one small catch. She had recently gained 30 pounds. During COVID, she and her husband spent 18 months camped out in her parents’ guest room in upstate New York and had eaten their emotions with abandon. They ate when they were happy and ate more when they were sad. They ate when they felt isolated and again when they felt anxious. It didn’t help that her mother was a Culinary Institute–trained amateur chef. They both worked from home and logged long hours on Zoom calls. Because there was no home gym, they replaced their usual fitness club workouts in the city with leisurely strolls around the local lake. When I met her, Claudia categorically refused to entertain the notion of pregnancy until she reached her pre-COVID weight.

At the time, this all seemed quite reasonable to me. We outlined a plan including semaglutide (Wegovy) until she reached her target weight and then a minimum of 2 months off Wegovy prior to conception. We also lined up sessions with a dietitian and trainer and renewed her birth control pill. There was one detail I failed to mention to her: Birth control pills are less effective while on incretin hormones like semaglutide. The reason for my omission is that the medical community at large wasn’t yet aware of this issue. 

About 12 weeks into treatment, Claudia had lost 20 of the 30 pounds. She had canceled several appointments with the trainer and dietitian due to work conflicts. She messaged me over the weekend in a panic. Her period was late, and her pregnancy test was positive.

She had three pressing questions for me:

Q: How had this happened while she had taken the birth control pills faithfully?

A: I answered that the scientific reasons for the decrease in efficacy of birth control pills while on semaglutide medications are threefold: 

• Weight loss can improve menstrual cycle irregularities and improve fertility. In fact, I have been using semaglutide-like medications to treat polycystic ovary syndrome for decades, well before these medications became mainstream.
• The delayed gastric emptying inherent to incretins leads to decreased absorption of birth control pills.
• Finally, while this did not apply to Claudia, no medicine is particularly efficacious if vomited up shortly after taking. Wegovy is known to cause nausea and vomiting in a sizable percentage of patients.

Q: Would she have a healthy pregnancy given the lingering effects of Wegovy?

A: The short answer is: most likely yes. A review of the package insert revealed something fascinating. It was not strictly contraindicated. It advised doctors to weigh the risks and benefits of the medication during pregnancy. Animal studies have shown that semaglutide increases the risk for fetal death, birth defects, and growth issues, but this is probably due to restrictive eating patterns rather than a direct effect of the medication. A recent study of health records of more than 50,000 women with diabetes who had been inadvertently taking these medications in early pregnancy showed no increase in birth defects when compared with women who took insulin.

Q: What would happen to her weight loss efforts?

A: To address her third concern, I tried to offset the risk for rebound weight gain by stopping Wegovy and giving her metformin in the second and third trimesters. Considered a safe medication in pregnancy, metformin is thought to support weight loss, but it proved to be ineffective against the rebound weight gain from stopping Wegovy. Claudia had not resumed regular exercise and quickly fell into the age-old eating-for-two trap. She gained nearly 50 pounds over the course of her pregnancy. 

After a short and unfulfilling attempt at nursing, Claudia restarted Wegovy, this time in conjunction with a Mediterranean meal plan and regular sessions at a fitness club. After losing the pregnancy weight, she has been able to successfully maintain her ideal body weight for the past year, and her baby is perfectly healthy and beautiful. 

*Patient’s name changed. 

A version of this article appeared on Medscape.com.

Claudia* was a charming 27-year-old newlywed. She and her husband wanted to start a family — with one small catch. She had recently gained 30 pounds. During COVID, she and her husband spent 18 months camped out in her parents’ guest room in upstate New York and had eaten their emotions with abandon. They ate when they were happy and ate more when they were sad. They ate when they felt isolated and again when they felt anxious. It didn’t help that her mother was a Culinary Institute–trained amateur chef. They both worked from home and logged long hours on Zoom calls. Because there was no home gym, they replaced their usual fitness club workouts in the city with leisurely strolls around the local lake. When I met her, Claudia categorically refused to entertain the notion of pregnancy until she reached her pre-COVID weight.

At the time, this all seemed quite reasonable to me. We outlined a plan including semaglutide (Wegovy) until she reached her target weight and then a minimum of 2 months off Wegovy prior to conception. We also lined up sessions with a dietitian and trainer and renewed her birth control pill. There was one detail I failed to mention to her: Birth control pills are less effective while on incretin hormones like semaglutide. The reason for my omission is that the medical community at large wasn’t yet aware of this issue. 

About 12 weeks into treatment, Claudia had lost 20 of the 30 pounds. She had canceled several appointments with the trainer and dietitian due to work conflicts. She messaged me over the weekend in a panic. Her period was late, and her pregnancy test was positive.

She had three pressing questions for me:

Q: How had this happened while she had taken the birth control pills faithfully?

A: I answered that the scientific reasons for the decrease in efficacy of birth control pills while on semaglutide medications are threefold: 

• Weight loss can improve menstrual cycle irregularities and improve fertility. In fact, I have been using semaglutide-like medications to treat polycystic ovary syndrome for decades, well before these medications became mainstream.
• The delayed gastric emptying inherent to incretins leads to decreased absorption of birth control pills.
• Finally, while this did not apply to Claudia, no medicine is particularly efficacious if vomited up shortly after taking. Wegovy is known to cause nausea and vomiting in a sizable percentage of patients.

Q: Would she have a healthy pregnancy given the lingering effects of Wegovy?

A: The short answer is: most likely yes. A review of the package insert revealed something fascinating. It was not strictly contraindicated. It advised doctors to weigh the risks and benefits of the medication during pregnancy. Animal studies have shown that semaglutide increases the risk for fetal death, birth defects, and growth issues, but this is probably due to restrictive eating patterns rather than a direct effect of the medication. A recent study of health records of more than 50,000 women with diabetes who had been inadvertently taking these medications in early pregnancy showed no increase in birth defects when compared with women who took insulin.

Q: What would happen to her weight loss efforts?

A: To address her third concern, I tried to offset the risk for rebound weight gain by stopping Wegovy and giving her metformin in the second and third trimesters. Considered a safe medication in pregnancy, metformin is thought to support weight loss, but it proved to be ineffective against the rebound weight gain from stopping Wegovy. Claudia had not resumed regular exercise and quickly fell into the age-old eating-for-two trap. She gained nearly 50 pounds over the course of her pregnancy. 

After a short and unfulfilling attempt at nursing, Claudia restarted Wegovy, this time in conjunction with a Mediterranean meal plan and regular sessions at a fitness club. After losing the pregnancy weight, she has been able to successfully maintain her ideal body weight for the past year, and her baby is perfectly healthy and beautiful. 

*Patient’s name changed. 

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

[embed:render:related:node:267688]

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

[embed:render:related:node:267688]

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

[embed:render:related:node:267688]

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

Primary care clinicians have largely welcomed the arrival of Opill, the first over-the-counter (OTC) birth control pill from Perrigo, which will reach US pharmacy shelves this month. Although the medicine has a long-track record of safe use, physicians and nurse practitioners may want to ready themselves to answer questions from patients about shifting to the option.

The switch to OTC status for the norgestrel-only contraceptive has the support of many physician groups, including the American Medical Association, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists (ACOG).

The end of the prescription-requirement removes a barrier to access for many women, especially those who lack insurance. But it also will take away a chief reason many women in their childbearing years make appointments with doctors, as they will no longer need prescriptions for birth control pills.

Anne-Marie Amies Oelschlager, MD, professor of obstetrics and gynecology at University of Washington School of Medicine, in Seattle, Washington, said she is also worried that the availability of an OTC pill will lead to missed opportunities to help patients avoid sexually transmitted diseases. For example, patients can get counseling about the need for testing for sexually transmitted diseases at the start of new relationships during a visit made to obtain a prescription for the pill.

“My hope is that they still follow our recommendations, which is to get tested with every partner,” said Dr. Oelschlager, who cares for many patients in their teens. “Adolescents are at a particularly high risk of infection compared to older ones.”

When clinicians do see patients, they may want to raise the issue of the OTC option and proper use. Patients will need to closely read materials provided for Opill, a step they might skip due to the ready access, according to Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, which scrutinizes the safety of medical products.

“When something is sold over the counter, it’s perceived by individuals as being safe,” Dr. Zuckerman told this news organization. “There’s less concern and a little less interest in reading the instructions and reading the warnings.”
 

Considerations for Safety

The US Food and Drug Administration (FDA) in July approved the sales of a daily 0.075 mg norgestrel tablet without prescription. Perrigo told this news organization that it spent the intervening months ensuring retailers and consumers will receive education on the drug.

One of the biggest challenges for people using Opill may be sticking with the dosing schedule, according to Dr. Oelschlager.

“There are going to be people that have a harder time remembering to take a pill every day,” at the same time, said Dr. Oelschlager, who is chair of ACOG’s Clinical Consensus Gynecology Committee. “We need to watch and see what happens as it becomes more widely available, and people start using it.”

Unexpected vaginal bleeding is the most common adverse event linked to this form of birth control, with over one fifth of participants from one study of the OTC drug reporting this side effect, according to an FDA memo.

“It is more likely to be a tolerability issue rather than a safety issue,” the FDA wrote.

Many prescription of birth control options contain estrogen, which is associated with venous thromboembolism (VTE). But Opill contains only norgestrel, a form of progestin, which is not associated with thrombosis. Patients may be more likely to overestimate their potential risks for VTE than to underestimate them, according to Kwuan Paruchabutr, DNP, president of National Association of Nurse Practitioners in Women’s Health and an assistant professor at Georgetown University in Washington, DC.

“This is a progesterone-only pill: The risk is relatively low” of VTE, Dr. Paruchabutr said.

Clinicians should also take special care with patients who are prescribed drugs for seizures, tuberculosis, HIV/AIDS, and pulmonary hypertension or who are taking supplements containing St John’s wort.

Patients in their childbearing years who take isotretinoin are already expected to use some form of birth control.

“All patients on isotretinoin must be registered in the iPLEDGE program, which mandates monthly contraception counseling and monthly pregnancy tests for persons of childbearing potential,” Terrence A. Cronin, Jr, MD, president of the American Academy of Dermatology, told news organization through email.

Dr. Oelschlager noted that many patients who take isotretinoin may benefit from taking a birth control pill containing estrogen, for which they will need a prescription. At least three pills have an FDA-approved indication for treating moderate acne, including Ortho Tri-Cyclen, Estrostep, and Yaz.

The FDA has posted consumer-friendly information about the OTC pill that clinicians can refer their patients to. For clinicians who want more information, ACOG released a practice advisory about the switch in status for this progestin-only pill.
 

The Cost

While federal laws mandate employer-based and Medicaid plans cover prescription birth control pills for free, the OTC version will carry a cost, according to A. Mark Fendrick, MD, director of the University of Michigan Center for Value-Based Insurance Design in Ann Arbor, Michigan. 

Seven states, including New Mexico and New York, already have laws in effect that require health plans to cover certain OTC contraceptives without a prescription, according to a tally kept by the nonprofit research organization KFF.

Dr. Fendrick said it would be helpful for health plans to offer coverage for the OTC pill without copays even if they are not required to do so.

Priced at about $20 a month, Opill “is likely out of reach for many of the individuals who would most benefit from an OTC option,” Dr. Fendrick told this news organization in an email.

The new pill may be utilized most by those who do not have health insurance or have low incomes and cannot afford to see a doctor for a prescription, according to Sally Rafie, PharmD, a pharmacist specialist at University of California San Diego Health and founder of the Birth Control Pharmacist.

The manufacturer’s suggested retail prices will be $19.99 for a 1-month supply and $49.99 for a 3-month supply. Dublin-based Perrigo said it plans to offer a cost-assistance program for the drug in the coming weeks for people who have low incomes and lack insurance.

A version of this article appeared on Medscape.com.

Primary care clinicians have largely welcomed the arrival of Opill, the first over-the-counter (OTC) birth control pill from Perrigo, which will reach US pharmacy shelves this month. Although the medicine has a long-track record of safe use, physicians and nurse practitioners may want to ready themselves to answer questions from patients about shifting to the option.

The switch to OTC status for the norgestrel-only contraceptive has the support of many physician groups, including the American Medical Association, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists (ACOG).

The end of the prescription-requirement removes a barrier to access for many women, especially those who lack insurance. But it also will take away a chief reason many women in their childbearing years make appointments with doctors, as they will no longer need prescriptions for birth control pills.

Anne-Marie Amies Oelschlager, MD, professor of obstetrics and gynecology at University of Washington School of Medicine, in Seattle, Washington, said she is also worried that the availability of an OTC pill will lead to missed opportunities to help patients avoid sexually transmitted diseases. For example, patients can get counseling about the need for testing for sexually transmitted diseases at the start of new relationships during a visit made to obtain a prescription for the pill.

“My hope is that they still follow our recommendations, which is to get tested with every partner,” said Dr. Oelschlager, who cares for many patients in their teens. “Adolescents are at a particularly high risk of infection compared to older ones.”

When clinicians do see patients, they may want to raise the issue of the OTC option and proper use. Patients will need to closely read materials provided for Opill, a step they might skip due to the ready access, according to Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, which scrutinizes the safety of medical products.

“When something is sold over the counter, it’s perceived by individuals as being safe,” Dr. Zuckerman told this news organization. “There’s less concern and a little less interest in reading the instructions and reading the warnings.”
 

Considerations for Safety

The US Food and Drug Administration (FDA) in July approved the sales of a daily 0.075 mg norgestrel tablet without prescription. Perrigo told this news organization that it spent the intervening months ensuring retailers and consumers will receive education on the drug.

One of the biggest challenges for people using Opill may be sticking with the dosing schedule, according to Dr. Oelschlager.

“There are going to be people that have a harder time remembering to take a pill every day,” at the same time, said Dr. Oelschlager, who is chair of ACOG’s Clinical Consensus Gynecology Committee. “We need to watch and see what happens as it becomes more widely available, and people start using it.”

Unexpected vaginal bleeding is the most common adverse event linked to this form of birth control, with over one fifth of participants from one study of the OTC drug reporting this side effect, according to an FDA memo.

“It is more likely to be a tolerability issue rather than a safety issue,” the FDA wrote.

Many prescription of birth control options contain estrogen, which is associated with venous thromboembolism (VTE). But Opill contains only norgestrel, a form of progestin, which is not associated with thrombosis. Patients may be more likely to overestimate their potential risks for VTE than to underestimate them, according to Kwuan Paruchabutr, DNP, president of National Association of Nurse Practitioners in Women’s Health and an assistant professor at Georgetown University in Washington, DC.

“This is a progesterone-only pill: The risk is relatively low” of VTE, Dr. Paruchabutr said.

Clinicians should also take special care with patients who are prescribed drugs for seizures, tuberculosis, HIV/AIDS, and pulmonary hypertension or who are taking supplements containing St John’s wort.

Patients in their childbearing years who take isotretinoin are already expected to use some form of birth control.

“All patients on isotretinoin must be registered in the iPLEDGE program, which mandates monthly contraception counseling and monthly pregnancy tests for persons of childbearing potential,” Terrence A. Cronin, Jr, MD, president of the American Academy of Dermatology, told news organization through email.

Dr. Oelschlager noted that many patients who take isotretinoin may benefit from taking a birth control pill containing estrogen, for which they will need a prescription. At least three pills have an FDA-approved indication for treating moderate acne, including Ortho Tri-Cyclen, Estrostep, and Yaz.

The FDA has posted consumer-friendly information about the OTC pill that clinicians can refer their patients to. For clinicians who want more information, ACOG released a practice advisory about the switch in status for this progestin-only pill.
 

The Cost

While federal laws mandate employer-based and Medicaid plans cover prescription birth control pills for free, the OTC version will carry a cost, according to A. Mark Fendrick, MD, director of the University of Michigan Center for Value-Based Insurance Design in Ann Arbor, Michigan. 

Seven states, including New Mexico and New York, already have laws in effect that require health plans to cover certain OTC contraceptives without a prescription, according to a tally kept by the nonprofit research organization KFF.

Dr. Fendrick said it would be helpful for health plans to offer coverage for the OTC pill without copays even if they are not required to do so.

Priced at about $20 a month, Opill “is likely out of reach for many of the individuals who would most benefit from an OTC option,” Dr. Fendrick told this news organization in an email.

The new pill may be utilized most by those who do not have health insurance or have low incomes and cannot afford to see a doctor for a prescription, according to Sally Rafie, PharmD, a pharmacist specialist at University of California San Diego Health and founder of the Birth Control Pharmacist.

The manufacturer’s suggested retail prices will be $19.99 for a 1-month supply and $49.99 for a 3-month supply. Dublin-based Perrigo said it plans to offer a cost-assistance program for the drug in the coming weeks for people who have low incomes and lack insurance.

A version of this article appeared on Medscape.com.

Primary care clinicians have largely welcomed the arrival of Opill, the first over-the-counter (OTC) birth control pill from Perrigo, which will reach US pharmacy shelves this month. Although the medicine has a long-track record of safe use, physicians and nurse practitioners may want to ready themselves to answer questions from patients about shifting to the option.

The switch to OTC status for the norgestrel-only contraceptive has the support of many physician groups, including the American Medical Association, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists (ACOG).

The end of the prescription-requirement removes a barrier to access for many women, especially those who lack insurance. But it also will take away a chief reason many women in their childbearing years make appointments with doctors, as they will no longer need prescriptions for birth control pills.

Anne-Marie Amies Oelschlager, MD, professor of obstetrics and gynecology at University of Washington School of Medicine, in Seattle, Washington, said she is also worried that the availability of an OTC pill will lead to missed opportunities to help patients avoid sexually transmitted diseases. For example, patients can get counseling about the need for testing for sexually transmitted diseases at the start of new relationships during a visit made to obtain a prescription for the pill.

“My hope is that they still follow our recommendations, which is to get tested with every partner,” said Dr. Oelschlager, who cares for many patients in their teens. “Adolescents are at a particularly high risk of infection compared to older ones.”

When clinicians do see patients, they may want to raise the issue of the OTC option and proper use. Patients will need to closely read materials provided for Opill, a step they might skip due to the ready access, according to Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, which scrutinizes the safety of medical products.

“When something is sold over the counter, it’s perceived by individuals as being safe,” Dr. Zuckerman told this news organization. “There’s less concern and a little less interest in reading the instructions and reading the warnings.”
 

Considerations for Safety

The US Food and Drug Administration (FDA) in July approved the sales of a daily 0.075 mg norgestrel tablet without prescription. Perrigo told this news organization that it spent the intervening months ensuring retailers and consumers will receive education on the drug.

One of the biggest challenges for people using Opill may be sticking with the dosing schedule, according to Dr. Oelschlager.

“There are going to be people that have a harder time remembering to take a pill every day,” at the same time, said Dr. Oelschlager, who is chair of ACOG’s Clinical Consensus Gynecology Committee. “We need to watch and see what happens as it becomes more widely available, and people start using it.”

Unexpected vaginal bleeding is the most common adverse event linked to this form of birth control, with over one fifth of participants from one study of the OTC drug reporting this side effect, according to an FDA memo.

“It is more likely to be a tolerability issue rather than a safety issue,” the FDA wrote.

Many prescription of birth control options contain estrogen, which is associated with venous thromboembolism (VTE). But Opill contains only norgestrel, a form of progestin, which is not associated with thrombosis. Patients may be more likely to overestimate their potential risks for VTE than to underestimate them, according to Kwuan Paruchabutr, DNP, president of National Association of Nurse Practitioners in Women’s Health and an assistant professor at Georgetown University in Washington, DC.

“This is a progesterone-only pill: The risk is relatively low” of VTE, Dr. Paruchabutr said.

Clinicians should also take special care with patients who are prescribed drugs for seizures, tuberculosis, HIV/AIDS, and pulmonary hypertension or who are taking supplements containing St John’s wort.

Patients in their childbearing years who take isotretinoin are already expected to use some form of birth control.

“All patients on isotretinoin must be registered in the iPLEDGE program, which mandates monthly contraception counseling and monthly pregnancy tests for persons of childbearing potential,” Terrence A. Cronin, Jr, MD, president of the American Academy of Dermatology, told news organization through email.

Dr. Oelschlager noted that many patients who take isotretinoin may benefit from taking a birth control pill containing estrogen, for which they will need a prescription. At least three pills have an FDA-approved indication for treating moderate acne, including Ortho Tri-Cyclen, Estrostep, and Yaz.

The FDA has posted consumer-friendly information about the OTC pill that clinicians can refer their patients to. For clinicians who want more information, ACOG released a practice advisory about the switch in status for this progestin-only pill.
 

The Cost

While federal laws mandate employer-based and Medicaid plans cover prescription birth control pills for free, the OTC version will carry a cost, according to A. Mark Fendrick, MD, director of the University of Michigan Center for Value-Based Insurance Design in Ann Arbor, Michigan. 

Seven states, including New Mexico and New York, already have laws in effect that require health plans to cover certain OTC contraceptives without a prescription, according to a tally kept by the nonprofit research organization KFF.

Dr. Fendrick said it would be helpful for health plans to offer coverage for the OTC pill without copays even if they are not required to do so.

Priced at about $20 a month, Opill “is likely out of reach for many of the individuals who would most benefit from an OTC option,” Dr. Fendrick told this news organization in an email.

The new pill may be utilized most by those who do not have health insurance or have low incomes and cannot afford to see a doctor for a prescription, according to Sally Rafie, PharmD, a pharmacist specialist at University of California San Diego Health and founder of the Birth Control Pharmacist.

The manufacturer’s suggested retail prices will be $19.99 for a 1-month supply and $49.99 for a 3-month supply. Dublin-based Perrigo said it plans to offer a cost-assistance program for the drug in the coming weeks for people who have low incomes and lack insurance.

A version of this article appeared on Medscape.com.

A journal and publisher have retracted three papers about abortion, including one that has been used in court cases to support the suspension of FDA approval for mifepristone, aka an “abortion pill.”

Sage, the publisher of Health Services Research and Managerial Epidemiology, announced the retractions yesterday and posted a retraction notice covering the three articles.

For one of those articles, initially flagged by a reader, “an independent reviewer with expertise in statistical analyses evaluated the concerns and opined that the article’s presentation of the data in Figures 2 and 3 leads to an inaccurate conclusion and that the composition of the cohort studied has problems that could affect the article’s conclusions,” according to the notice.

The notice also said Sage “confirmed that all but one of the article’s authors had an affiliation with one or more of Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists, all pro-life advocacy organizations, despite having declared they had no conflicts of interest when they submitted the article for publication or in the article itself.” 

One of the peer reviewers, Sage learned, “was affiliated with Charlotte Lozier Institute at the time of the review,” leading the publisher and journal editor to determine “the peer review for initial publication was unreliable.” That referee also reviewed the other two now-retracted papers, according to Sage.

James Studnicki, the lead author of the three papers, told Retraction Watch the retractions were “a blatant attempt to discredit excellent research which is incongruent with a preferred abortion narrative.” He told The Daily Wire, a conservative news outlet that was first to report on the retractions, the move was “completely unjustified.” The Daily Wire notes that “The Supreme Court is set to hear arguments in March on the legality of restricting the abortion pill based on [Judge Matthew] Kacsmaryk’s ruling, proceedings that will certainly be impacted by the retractions.”

Sage had subjected one of the papers to an expression of concern in August 2023, saying they were investigating “potential issues regarding the representation of data in the article and author conflicts of interest” after being alerted by a reader. As News From The States reported then, the notice came after Chris Adkins, a professor at South University who teaches pharmaceutical sciences, raised concerns with Sage. As News From The States noted in August:

Kacsmaryk leaned hard on a 2021 study that was designed, funded and produced by the research arm of one of the most powerful anti-abortion political groups in the U.S. The judge cited this paper — which looked at Medicaid patients’ visits to the emergency room within 30 days of having an abortion — to justify that a group of anti-abortion doctors and medical groups have legal standing to force the FDA to recall mifepristone.

In a point-by-point response to Sage’s critiques of the paper sent to the publisher in November and now shared with Retraction Watch, Studnicki and colleagues pointed out they had noted their affiliations in the original manuscript and the then-proposed retractions “misrepresent ICMJE disclosure standards,” referring to the International Committee of Medical Journal Editors’ guidelines. They also call some of the post-publication peer reviewers’ critiques “factually incorrect” and “unfounded.” They conclude:

No single specific finding in any of the three papers has been explicitly challenged, let alone invalidated.

There is no evidence of a major error, miscalculation, fabrication, or falsification.

There is no breach of any of the COPE guidelines that could permit Sage to retract any of our published papers.

The retraction of any of these papers, let alone all three, is demonstrably unwarranted.

Adkins told Retraction Watch he is “pleased the journal approached my concerns with legitimate and serious consideration.” He continued:

It is reassuring that my initial concerns with the 2021 Studnicki et al. article were verified and affirmed by other experts. Despite the length of time spanning my initial communications with the journal and today’s retractions, I understand that thorough investigations and re-review processes take time. Given that these now-retracted articles have been excessively cited by parties involved in ongoing federal judicial cases, now positioned before the SCOTUS, Sage’s retractions should help our courts remain informed by the highest standards and quality in scientific and medical evidence.

Update, 2/6/24, 2100 UTC: We note that — contrary to best industry practices described by the Committee on Publication Ethics — Sage has removed the original versions of the articles. They are available at these links:

“A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015”

“Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges”

“A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization”

DISCLOSURE: Adam Marcus, a cofounder of Retraction Watch, is an editor at Medscape.

A version of this article appeared on Medscape.com.

A journal and publisher have retracted three papers about abortion, including one that has been used in court cases to support the suspension of FDA approval for mifepristone, aka an “abortion pill.”

Sage, the publisher of Health Services Research and Managerial Epidemiology, announced the retractions yesterday and posted a retraction notice covering the three articles.

For one of those articles, initially flagged by a reader, “an independent reviewer with expertise in statistical analyses evaluated the concerns and opined that the article’s presentation of the data in Figures 2 and 3 leads to an inaccurate conclusion and that the composition of the cohort studied has problems that could affect the article’s conclusions,” according to the notice.

The notice also said Sage “confirmed that all but one of the article’s authors had an affiliation with one or more of Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists, all pro-life advocacy organizations, despite having declared they had no conflicts of interest when they submitted the article for publication or in the article itself.” 

One of the peer reviewers, Sage learned, “was affiliated with Charlotte Lozier Institute at the time of the review,” leading the publisher and journal editor to determine “the peer review for initial publication was unreliable.” That referee also reviewed the other two now-retracted papers, according to Sage.

James Studnicki, the lead author of the three papers, told Retraction Watch the retractions were “a blatant attempt to discredit excellent research which is incongruent with a preferred abortion narrative.” He told The Daily Wire, a conservative news outlet that was first to report on the retractions, the move was “completely unjustified.” The Daily Wire notes that “The Supreme Court is set to hear arguments in March on the legality of restricting the abortion pill based on [Judge Matthew] Kacsmaryk’s ruling, proceedings that will certainly be impacted by the retractions.”

Sage had subjected one of the papers to an expression of concern in August 2023, saying they were investigating “potential issues regarding the representation of data in the article and author conflicts of interest” after being alerted by a reader. As News From The States reported then, the notice came after Chris Adkins, a professor at South University who teaches pharmaceutical sciences, raised concerns with Sage. As News From The States noted in August:

Kacsmaryk leaned hard on a 2021 study that was designed, funded and produced by the research arm of one of the most powerful anti-abortion political groups in the U.S. The judge cited this paper — which looked at Medicaid patients’ visits to the emergency room within 30 days of having an abortion — to justify that a group of anti-abortion doctors and medical groups have legal standing to force the FDA to recall mifepristone.

In a point-by-point response to Sage’s critiques of the paper sent to the publisher in November and now shared with Retraction Watch, Studnicki and colleagues pointed out they had noted their affiliations in the original manuscript and the then-proposed retractions “misrepresent ICMJE disclosure standards,” referring to the International Committee of Medical Journal Editors’ guidelines. They also call some of the post-publication peer reviewers’ critiques “factually incorrect” and “unfounded.” They conclude:

No single specific finding in any of the three papers has been explicitly challenged, let alone invalidated.

There is no evidence of a major error, miscalculation, fabrication, or falsification.

There is no breach of any of the COPE guidelines that could permit Sage to retract any of our published papers.

The retraction of any of these papers, let alone all three, is demonstrably unwarranted.

Adkins told Retraction Watch he is “pleased the journal approached my concerns with legitimate and serious consideration.” He continued:

It is reassuring that my initial concerns with the 2021 Studnicki et al. article were verified and affirmed by other experts. Despite the length of time spanning my initial communications with the journal and today’s retractions, I understand that thorough investigations and re-review processes take time. Given that these now-retracted articles have been excessively cited by parties involved in ongoing federal judicial cases, now positioned before the SCOTUS, Sage’s retractions should help our courts remain informed by the highest standards and quality in scientific and medical evidence.

Update, 2/6/24, 2100 UTC: We note that — contrary to best industry practices described by the Committee on Publication Ethics — Sage has removed the original versions of the articles. They are available at these links:

“A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015”

“Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges”

“A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization”

DISCLOSURE: Adam Marcus, a cofounder of Retraction Watch, is an editor at Medscape.

A version of this article appeared on Medscape.com.

A journal and publisher have retracted three papers about abortion, including one that has been used in court cases to support the suspension of FDA approval for mifepristone, aka an “abortion pill.”

Sage, the publisher of Health Services Research and Managerial Epidemiology, announced the retractions yesterday and posted a retraction notice covering the three articles.

For one of those articles, initially flagged by a reader, “an independent reviewer with expertise in statistical analyses evaluated the concerns and opined that the article’s presentation of the data in Figures 2 and 3 leads to an inaccurate conclusion and that the composition of the cohort studied has problems that could affect the article’s conclusions,” according to the notice.

The notice also said Sage “confirmed that all but one of the article’s authors had an affiliation with one or more of Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists, all pro-life advocacy organizations, despite having declared they had no conflicts of interest when they submitted the article for publication or in the article itself.” 

One of the peer reviewers, Sage learned, “was affiliated with Charlotte Lozier Institute at the time of the review,” leading the publisher and journal editor to determine “the peer review for initial publication was unreliable.” That referee also reviewed the other two now-retracted papers, according to Sage.

James Studnicki, the lead author of the three papers, told Retraction Watch the retractions were “a blatant attempt to discredit excellent research which is incongruent with a preferred abortion narrative.” He told The Daily Wire, a conservative news outlet that was first to report on the retractions, the move was “completely unjustified.” The Daily Wire notes that “The Supreme Court is set to hear arguments in March on the legality of restricting the abortion pill based on [Judge Matthew] Kacsmaryk’s ruling, proceedings that will certainly be impacted by the retractions.”

Sage had subjected one of the papers to an expression of concern in August 2023, saying they were investigating “potential issues regarding the representation of data in the article and author conflicts of interest” after being alerted by a reader. As News From The States reported then, the notice came after Chris Adkins, a professor at South University who teaches pharmaceutical sciences, raised concerns with Sage. As News From The States noted in August:

Kacsmaryk leaned hard on a 2021 study that was designed, funded and produced by the research arm of one of the most powerful anti-abortion political groups in the U.S. The judge cited this paper — which looked at Medicaid patients’ visits to the emergency room within 30 days of having an abortion — to justify that a group of anti-abortion doctors and medical groups have legal standing to force the FDA to recall mifepristone.

In a point-by-point response to Sage’s critiques of the paper sent to the publisher in November and now shared with Retraction Watch, Studnicki and colleagues pointed out they had noted their affiliations in the original manuscript and the then-proposed retractions “misrepresent ICMJE disclosure standards,” referring to the International Committee of Medical Journal Editors’ guidelines. They also call some of the post-publication peer reviewers’ critiques “factually incorrect” and “unfounded.” They conclude:

No single specific finding in any of the three papers has been explicitly challenged, let alone invalidated.

There is no evidence of a major error, miscalculation, fabrication, or falsification.

There is no breach of any of the COPE guidelines that could permit Sage to retract any of our published papers.

The retraction of any of these papers, let alone all three, is demonstrably unwarranted.

Adkins told Retraction Watch he is “pleased the journal approached my concerns with legitimate and serious consideration.” He continued:

It is reassuring that my initial concerns with the 2021 Studnicki et al. article were verified and affirmed by other experts. Despite the length of time spanning my initial communications with the journal and today’s retractions, I understand that thorough investigations and re-review processes take time. Given that these now-retracted articles have been excessively cited by parties involved in ongoing federal judicial cases, now positioned before the SCOTUS, Sage’s retractions should help our courts remain informed by the highest standards and quality in scientific and medical evidence.

Update, 2/6/24, 2100 UTC: We note that — contrary to best industry practices described by the Committee on Publication Ethics — Sage has removed the original versions of the articles. They are available at these links:

“A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015”

“Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges”

“A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization”

DISCLOSURE: Adam Marcus, a cofounder of Retraction Watch, is an editor at Medscape.

A version of this article appeared on Medscape.com.