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How about contraceptives for men?
With the introduction of new technology to vaccinate the world with the Pfizer and Moderna mRNA vaccines, I considered other health conditions that could benefit from new modalities. Unplanned pregnancies are a public health crisis, yet the burden falls solely on women to solve, burdening them with contraceptive practices to prevent unplanned pregnancy. With the insurrection of Row v. Wade and the new bills being pushed through states that are limiting abortion, perhaps the time has come for males to accept the responsibility for contraception to prevent unplanned pregnancy. The methods that currently exist for males are condoms and vasectomy. Other options are being explored – both nonhormonal and reversible contraception including daily pills, gels, and long-acting injections.
The pill for men has been under preliminary trials with promising results. This contraceptive pill contains dimethandrolone undecanoate, which is an androgen anabolic steroid progesterone once-daily pill that suppresses FSH and LH, causing a decrease in the production of testosterone and consequently sperm production.1 (Long, Lee, & Blithe, 2019). This pill is in long-term trials to determine the efficacy and side effects, including the impact on libido, liver, and kidney disease.
The injectable male contraceptive in trials now includes two different options. The first was a long-acting progestin, testosterone, and androgen combination. The male participants received an intramuscular injection every 8 weeks. Although the results of the study were promising – sperm production was effectively reduced, the side effects were too severe for participants to continue use. Side effects much like those of the female Depo-Provera injections included acne and mood disorders. Men experienced erectile dysfunction while at the same time having an increase in sex drive.2 (Em, 2018).
Recently, researchers in India have studied a nonhormonal injectable with promising outcomes. It prevented pregnancy in more than 97% of participants. This injectable polymer gel is placed into the male’s vas deferens to block sperm from leaving the body. This product inactivates sperm, essentially creating temporary sterilization for men. The benefit of this product, called RISUG (reversible inhibition of sperm under guidance), is a single injection that can be effective for 13 years. It can be reversed earlier if needed by injecting a dissolving gel into the male’s vas deferens.1,2 In the United States, there is an identical product called Vasalgel – a polymer injected into the vas deferens – also being studied for temporary infertility.
Another synthetic implanted androgen product being studied is 7 alpha-methyl-19-nortestosterone (MENT), a synthetic steroid that resembles testosterone but does not convert into testosterone and, consequently, does not stimulate prostate growth. It is administered via two subdermal implants and is effective for 12 months. The first subdermal implant releases the synthetic androgen, which is more potent than testosterone, and the other emits LH-releasing hormone.3 Studies demonstrate that MENT suppresses sperm production.1
Finally, studies are underway using transdermal gel applications to suppress sperm concentrations. The daily gel is absorbed through the skin after application to two different areas of the man’s body: the shoulders and upper arms. The daily application of the progestin product, Nestorone, and testosterone gel has been found to reduce sperm concentrations to < 1 x 106/mL. Studies measured gonadal concentrations after 4 weeks.1 Users were happy with the use of a topical gel, with minimal side effects such as lower libido, weight gain, and changes in cholesterol, yet inconsistent use of the product resulted in lower than anticipated results.4
Male contraceptive options are long overdue to dramatically reduce the rate of unplanned pregnancies and the burden of contraception placed on women. Getting these products to market will be half the battle – getting men to commit to using these options and women to trust male compliance may further impede acceptance. Men have not had to carry the burden and economics of single parenting. Men interested in casual sex may now need to accept more responsibility for unplanned pregnancy and be proactive with prevention, particularly as abortion laws are being challenged.
Ms. Thew is medical director of the department of pediatrics division of adolescent medicine at the Medical College of Wisconsin in Milwaukee. She is a member of the editorial board for Pediatric News and has no relevant disclosures.
References
1. Long J E et al. Clin Chem. 2019;65(1):153-60.
2. Male birth control: Current options and new breakthroughs, SingleCare: Health Education. Aug. 6, 2018.
3. Sundaram K et al. Ann Med. 1993;25(2):199-205.
4. Anawalt BD et al. Andrology. 2019;7(6):878-87.
With the introduction of new technology to vaccinate the world with the Pfizer and Moderna mRNA vaccines, I considered other health conditions that could benefit from new modalities. Unplanned pregnancies are a public health crisis, yet the burden falls solely on women to solve, burdening them with contraceptive practices to prevent unplanned pregnancy. With the insurrection of Row v. Wade and the new bills being pushed through states that are limiting abortion, perhaps the time has come for males to accept the responsibility for contraception to prevent unplanned pregnancy. The methods that currently exist for males are condoms and vasectomy. Other options are being explored – both nonhormonal and reversible contraception including daily pills, gels, and long-acting injections.
The pill for men has been under preliminary trials with promising results. This contraceptive pill contains dimethandrolone undecanoate, which is an androgen anabolic steroid progesterone once-daily pill that suppresses FSH and LH, causing a decrease in the production of testosterone and consequently sperm production.1 (Long, Lee, & Blithe, 2019). This pill is in long-term trials to determine the efficacy and side effects, including the impact on libido, liver, and kidney disease.
The injectable male contraceptive in trials now includes two different options. The first was a long-acting progestin, testosterone, and androgen combination. The male participants received an intramuscular injection every 8 weeks. Although the results of the study were promising – sperm production was effectively reduced, the side effects were too severe for participants to continue use. Side effects much like those of the female Depo-Provera injections included acne and mood disorders. Men experienced erectile dysfunction while at the same time having an increase in sex drive.2 (Em, 2018).
Recently, researchers in India have studied a nonhormonal injectable with promising outcomes. It prevented pregnancy in more than 97% of participants. This injectable polymer gel is placed into the male’s vas deferens to block sperm from leaving the body. This product inactivates sperm, essentially creating temporary sterilization for men. The benefit of this product, called RISUG (reversible inhibition of sperm under guidance), is a single injection that can be effective for 13 years. It can be reversed earlier if needed by injecting a dissolving gel into the male’s vas deferens.1,2 In the United States, there is an identical product called Vasalgel – a polymer injected into the vas deferens – also being studied for temporary infertility.
Another synthetic implanted androgen product being studied is 7 alpha-methyl-19-nortestosterone (MENT), a synthetic steroid that resembles testosterone but does not convert into testosterone and, consequently, does not stimulate prostate growth. It is administered via two subdermal implants and is effective for 12 months. The first subdermal implant releases the synthetic androgen, which is more potent than testosterone, and the other emits LH-releasing hormone.3 Studies demonstrate that MENT suppresses sperm production.1
Finally, studies are underway using transdermal gel applications to suppress sperm concentrations. The daily gel is absorbed through the skin after application to two different areas of the man’s body: the shoulders and upper arms. The daily application of the progestin product, Nestorone, and testosterone gel has been found to reduce sperm concentrations to < 1 x 106/mL. Studies measured gonadal concentrations after 4 weeks.1 Users were happy with the use of a topical gel, with minimal side effects such as lower libido, weight gain, and changes in cholesterol, yet inconsistent use of the product resulted in lower than anticipated results.4
Male contraceptive options are long overdue to dramatically reduce the rate of unplanned pregnancies and the burden of contraception placed on women. Getting these products to market will be half the battle – getting men to commit to using these options and women to trust male compliance may further impede acceptance. Men have not had to carry the burden and economics of single parenting. Men interested in casual sex may now need to accept more responsibility for unplanned pregnancy and be proactive with prevention, particularly as abortion laws are being challenged.
Ms. Thew is medical director of the department of pediatrics division of adolescent medicine at the Medical College of Wisconsin in Milwaukee. She is a member of the editorial board for Pediatric News and has no relevant disclosures.
References
1. Long J E et al. Clin Chem. 2019;65(1):153-60.
2. Male birth control: Current options and new breakthroughs, SingleCare: Health Education. Aug. 6, 2018.
3. Sundaram K et al. Ann Med. 1993;25(2):199-205.
4. Anawalt BD et al. Andrology. 2019;7(6):878-87.
With the introduction of new technology to vaccinate the world with the Pfizer and Moderna mRNA vaccines, I considered other health conditions that could benefit from new modalities. Unplanned pregnancies are a public health crisis, yet the burden falls solely on women to solve, burdening them with contraceptive practices to prevent unplanned pregnancy. With the insurrection of Row v. Wade and the new bills being pushed through states that are limiting abortion, perhaps the time has come for males to accept the responsibility for contraception to prevent unplanned pregnancy. The methods that currently exist for males are condoms and vasectomy. Other options are being explored – both nonhormonal and reversible contraception including daily pills, gels, and long-acting injections.
The pill for men has been under preliminary trials with promising results. This contraceptive pill contains dimethandrolone undecanoate, which is an androgen anabolic steroid progesterone once-daily pill that suppresses FSH and LH, causing a decrease in the production of testosterone and consequently sperm production.1 (Long, Lee, & Blithe, 2019). This pill is in long-term trials to determine the efficacy and side effects, including the impact on libido, liver, and kidney disease.
The injectable male contraceptive in trials now includes two different options. The first was a long-acting progestin, testosterone, and androgen combination. The male participants received an intramuscular injection every 8 weeks. Although the results of the study were promising – sperm production was effectively reduced, the side effects were too severe for participants to continue use. Side effects much like those of the female Depo-Provera injections included acne and mood disorders. Men experienced erectile dysfunction while at the same time having an increase in sex drive.2 (Em, 2018).
Recently, researchers in India have studied a nonhormonal injectable with promising outcomes. It prevented pregnancy in more than 97% of participants. This injectable polymer gel is placed into the male’s vas deferens to block sperm from leaving the body. This product inactivates sperm, essentially creating temporary sterilization for men. The benefit of this product, called RISUG (reversible inhibition of sperm under guidance), is a single injection that can be effective for 13 years. It can be reversed earlier if needed by injecting a dissolving gel into the male’s vas deferens.1,2 In the United States, there is an identical product called Vasalgel – a polymer injected into the vas deferens – also being studied for temporary infertility.
Another synthetic implanted androgen product being studied is 7 alpha-methyl-19-nortestosterone (MENT), a synthetic steroid that resembles testosterone but does not convert into testosterone and, consequently, does not stimulate prostate growth. It is administered via two subdermal implants and is effective for 12 months. The first subdermal implant releases the synthetic androgen, which is more potent than testosterone, and the other emits LH-releasing hormone.3 Studies demonstrate that MENT suppresses sperm production.1
Finally, studies are underway using transdermal gel applications to suppress sperm concentrations. The daily gel is absorbed through the skin after application to two different areas of the man’s body: the shoulders and upper arms. The daily application of the progestin product, Nestorone, and testosterone gel has been found to reduce sperm concentrations to < 1 x 106/mL. Studies measured gonadal concentrations after 4 weeks.1 Users were happy with the use of a topical gel, with minimal side effects such as lower libido, weight gain, and changes in cholesterol, yet inconsistent use of the product resulted in lower than anticipated results.4
Male contraceptive options are long overdue to dramatically reduce the rate of unplanned pregnancies and the burden of contraception placed on women. Getting these products to market will be half the battle – getting men to commit to using these options and women to trust male compliance may further impede acceptance. Men have not had to carry the burden and economics of single parenting. Men interested in casual sex may now need to accept more responsibility for unplanned pregnancy and be proactive with prevention, particularly as abortion laws are being challenged.
Ms. Thew is medical director of the department of pediatrics division of adolescent medicine at the Medical College of Wisconsin in Milwaukee. She is a member of the editorial board for Pediatric News and has no relevant disclosures.
References
1. Long J E et al. Clin Chem. 2019;65(1):153-60.
2. Male birth control: Current options and new breakthroughs, SingleCare: Health Education. Aug. 6, 2018.
3. Sundaram K et al. Ann Med. 1993;25(2):199-205.
4. Anawalt BD et al. Andrology. 2019;7(6):878-87.
What have we learned from COVID?
In 2015, I proposed virtual care for the division of adolescent medicine, to the administration of our Midwestern children and adolescent hospital; they gladly listened and accepted a copy of the resources I provided. Virtual care was acknowledged to be the future direction of our and other organizations.
Four years later, virtual visits were introduced in the pediatric urgent care, but with little usability as families were slow to adopt this new form of medicine. Fast forward to the COVID-19 crisis in March 2020, and virtual medicine was the only option to meet the needs of patients and to stop the economic consequences. Unfortunately, the expedited rollout at our and many other hospitals may have resulted in limited program development and a lack of shared best practices.
Since March 2020, both patients and medical providers have accepted virtual care, but we now have an opportunity to review some of the limitations to offering virtual care. Work in primary care centers may see limitations using virtual medicine to meet the needs of all patients. Take into consideration the ability to offer confidential care. Confidential care has been a challenge virtually. For example, while completing a virtual visit with a 19-year-old female, it was apparent she was not alone and when asked a benign question the commotion in the background told the real story. The young woman began to laugh and said, “That was my dad running out of the room.” Despite requesting that parents leave the call, they can be heard within earshot of the caller.
On a televisit, written words appear backwards on the video, requiring written questions to be mirror images. When asking questions meant to be confidential, we have used note cards with a question mark. Verbal directions asking the adolescent to give a thumbs up or down to answer the question are required to maintain privacy from others in the room. If the patient responds thumbs up, this leads to additional questions with note cards. Although not ideal, this process gets to the answers, and the adolescent can disclose confidential information without concern about being overheard. Child abuse and neglect professionals have found similar challenges talking to caregivers or children as they are uncertain if others in the home are out of the screen but listening to the questions or prompting responses.
Obtaining vitals may be restricted and picking up hypertension or changes in weight has been limited to face to face visits. To continue to provide virtual care will require screening stations. I foresee a kiosk at the grocery or drugstore with a computer and the ability to obtain vitals or portions of an exam such as heart and lung evaluations. Patients could go at their convenience and the results could be sent to their providers. Technology already exists to use a cell phone to take photos of a toddler’s sore ear drum, and to obtain basic pulse oximetry and ECG, but these have a cost and may be available only to those able to afford these tools.
Billing issues have developed when patients go to a lab on the same day as a virtual visit. Completing a virtual visit for a sore throat thought to be streptococcal pharyngitis should not be finalized without access to a streptococcal throat swab. Until families have home kits to evaluate for strep throat, the families must bring the patient to a clinic or lab to obtain a pharyngeal culture. Furthermore, insurance reimbursement standards will need to be set for ongoing virtual health to become a sustainable option.
Workflows have been disrupted by balancing face to face visits with virtual visits. Unless the virtual visit has been set up for the medical team to access immediately, there are delays accessing the virtual platform, resulting in unnecessary gaps in care. Arranging schedules to separate face to face visits from virtual visits offers more efficiency. Creating a block of virtual visits separated from face-to-face visits or assigning providers to virtual-only schedules may be the best option for an efficient clinic flow. Telemedicine visit templates may need to be created as virtual visits become standard practice.
At present, virtual visits can only be offered to English-speaking patients. The inability to offer translators limits access to a small number of patients. Given COVID-19’s impact on the underserved communities, having a safe resource to reach these patients has been limited, leaving face-to-face visits as their only option. Requiring a face-to-face visit during peak illness has placed patients at risk. They have refused health care as opposed to exposure to the illness in health care settings.
We have innovative opportunities to create a new health care system. Despite the initial struggles with the adoption of virtual care, patients and providers have begun embracing the technology. Best practices and shared resources will be required to have a successful system before brick and mortar organizations can be reduced or insurance companies create their own health care systems which can branch across state lines.
Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
The article was updated 7/17/2020.
In 2015, I proposed virtual care for the division of adolescent medicine, to the administration of our Midwestern children and adolescent hospital; they gladly listened and accepted a copy of the resources I provided. Virtual care was acknowledged to be the future direction of our and other organizations.
Four years later, virtual visits were introduced in the pediatric urgent care, but with little usability as families were slow to adopt this new form of medicine. Fast forward to the COVID-19 crisis in March 2020, and virtual medicine was the only option to meet the needs of patients and to stop the economic consequences. Unfortunately, the expedited rollout at our and many other hospitals may have resulted in limited program development and a lack of shared best practices.
Since March 2020, both patients and medical providers have accepted virtual care, but we now have an opportunity to review some of the limitations to offering virtual care. Work in primary care centers may see limitations using virtual medicine to meet the needs of all patients. Take into consideration the ability to offer confidential care. Confidential care has been a challenge virtually. For example, while completing a virtual visit with a 19-year-old female, it was apparent she was not alone and when asked a benign question the commotion in the background told the real story. The young woman began to laugh and said, “That was my dad running out of the room.” Despite requesting that parents leave the call, they can be heard within earshot of the caller.
On a televisit, written words appear backwards on the video, requiring written questions to be mirror images. When asking questions meant to be confidential, we have used note cards with a question mark. Verbal directions asking the adolescent to give a thumbs up or down to answer the question are required to maintain privacy from others in the room. If the patient responds thumbs up, this leads to additional questions with note cards. Although not ideal, this process gets to the answers, and the adolescent can disclose confidential information without concern about being overheard. Child abuse and neglect professionals have found similar challenges talking to caregivers or children as they are uncertain if others in the home are out of the screen but listening to the questions or prompting responses.
Obtaining vitals may be restricted and picking up hypertension or changes in weight has been limited to face to face visits. To continue to provide virtual care will require screening stations. I foresee a kiosk at the grocery or drugstore with a computer and the ability to obtain vitals or portions of an exam such as heart and lung evaluations. Patients could go at their convenience and the results could be sent to their providers. Technology already exists to use a cell phone to take photos of a toddler’s sore ear drum, and to obtain basic pulse oximetry and ECG, but these have a cost and may be available only to those able to afford these tools.
Billing issues have developed when patients go to a lab on the same day as a virtual visit. Completing a virtual visit for a sore throat thought to be streptococcal pharyngitis should not be finalized without access to a streptococcal throat swab. Until families have home kits to evaluate for strep throat, the families must bring the patient to a clinic or lab to obtain a pharyngeal culture. Furthermore, insurance reimbursement standards will need to be set for ongoing virtual health to become a sustainable option.
Workflows have been disrupted by balancing face to face visits with virtual visits. Unless the virtual visit has been set up for the medical team to access immediately, there are delays accessing the virtual platform, resulting in unnecessary gaps in care. Arranging schedules to separate face to face visits from virtual visits offers more efficiency. Creating a block of virtual visits separated from face-to-face visits or assigning providers to virtual-only schedules may be the best option for an efficient clinic flow. Telemedicine visit templates may need to be created as virtual visits become standard practice.
At present, virtual visits can only be offered to English-speaking patients. The inability to offer translators limits access to a small number of patients. Given COVID-19’s impact on the underserved communities, having a safe resource to reach these patients has been limited, leaving face-to-face visits as their only option. Requiring a face-to-face visit during peak illness has placed patients at risk. They have refused health care as opposed to exposure to the illness in health care settings.
We have innovative opportunities to create a new health care system. Despite the initial struggles with the adoption of virtual care, patients and providers have begun embracing the technology. Best practices and shared resources will be required to have a successful system before brick and mortar organizations can be reduced or insurance companies create their own health care systems which can branch across state lines.
Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
The article was updated 7/17/2020.
In 2015, I proposed virtual care for the division of adolescent medicine, to the administration of our Midwestern children and adolescent hospital; they gladly listened and accepted a copy of the resources I provided. Virtual care was acknowledged to be the future direction of our and other organizations.
Four years later, virtual visits were introduced in the pediatric urgent care, but with little usability as families were slow to adopt this new form of medicine. Fast forward to the COVID-19 crisis in March 2020, and virtual medicine was the only option to meet the needs of patients and to stop the economic consequences. Unfortunately, the expedited rollout at our and many other hospitals may have resulted in limited program development and a lack of shared best practices.
Since March 2020, both patients and medical providers have accepted virtual care, but we now have an opportunity to review some of the limitations to offering virtual care. Work in primary care centers may see limitations using virtual medicine to meet the needs of all patients. Take into consideration the ability to offer confidential care. Confidential care has been a challenge virtually. For example, while completing a virtual visit with a 19-year-old female, it was apparent she was not alone and when asked a benign question the commotion in the background told the real story. The young woman began to laugh and said, “That was my dad running out of the room.” Despite requesting that parents leave the call, they can be heard within earshot of the caller.
On a televisit, written words appear backwards on the video, requiring written questions to be mirror images. When asking questions meant to be confidential, we have used note cards with a question mark. Verbal directions asking the adolescent to give a thumbs up or down to answer the question are required to maintain privacy from others in the room. If the patient responds thumbs up, this leads to additional questions with note cards. Although not ideal, this process gets to the answers, and the adolescent can disclose confidential information without concern about being overheard. Child abuse and neglect professionals have found similar challenges talking to caregivers or children as they are uncertain if others in the home are out of the screen but listening to the questions or prompting responses.
Obtaining vitals may be restricted and picking up hypertension or changes in weight has been limited to face to face visits. To continue to provide virtual care will require screening stations. I foresee a kiosk at the grocery or drugstore with a computer and the ability to obtain vitals or portions of an exam such as heart and lung evaluations. Patients could go at their convenience and the results could be sent to their providers. Technology already exists to use a cell phone to take photos of a toddler’s sore ear drum, and to obtain basic pulse oximetry and ECG, but these have a cost and may be available only to those able to afford these tools.
Billing issues have developed when patients go to a lab on the same day as a virtual visit. Completing a virtual visit for a sore throat thought to be streptococcal pharyngitis should not be finalized without access to a streptococcal throat swab. Until families have home kits to evaluate for strep throat, the families must bring the patient to a clinic or lab to obtain a pharyngeal culture. Furthermore, insurance reimbursement standards will need to be set for ongoing virtual health to become a sustainable option.
Workflows have been disrupted by balancing face to face visits with virtual visits. Unless the virtual visit has been set up for the medical team to access immediately, there are delays accessing the virtual platform, resulting in unnecessary gaps in care. Arranging schedules to separate face to face visits from virtual visits offers more efficiency. Creating a block of virtual visits separated from face-to-face visits or assigning providers to virtual-only schedules may be the best option for an efficient clinic flow. Telemedicine visit templates may need to be created as virtual visits become standard practice.
At present, virtual visits can only be offered to English-speaking patients. The inability to offer translators limits access to a small number of patients. Given COVID-19’s impact on the underserved communities, having a safe resource to reach these patients has been limited, leaving face-to-face visits as their only option. Requiring a face-to-face visit during peak illness has placed patients at risk. They have refused health care as opposed to exposure to the illness in health care settings.
We have innovative opportunities to create a new health care system. Despite the initial struggles with the adoption of virtual care, patients and providers have begun embracing the technology. Best practices and shared resources will be required to have a successful system before brick and mortar organizations can be reduced or insurance companies create their own health care systems which can branch across state lines.
Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
The article was updated 7/17/2020.