Pregnancy and safety rates evaluated for Liletta at 5 years of use

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Liletta, a levonorgestrel 52 mg contraceptive intrauterine system (IUS) (Allergan), is currently approved by the US Food and Drug Administration for up to 4 years of use. A multicenter trial is continuing to measure Liletta’s efficacy and safety for a total of 8 years of use.¹

Meanwhile, investigators led by Stephanie B. Teal, MD, from the University of Colorado, Aurora, have evaluated the 5-year data for Liletta. Researchers included David K. Turok, MD, from the University of Utah, Salt Lake City; Jeffrey T. Jensen, MD, from the Oregon Health & Science University, Portland; Beatrice A. Chen, MD, from the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Thomas D. Kimble, MD, from Eastern Virginia Medical School, Norfolk; and Mitchell D. Creinin, MD, from the University of California-Davis, Sacramento. Results were reported in a poster presentation at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists held in Austin, Texas, from April 27–30, 2018.¹

Study details

A total of 1,714 women aged 16−45 years were enrolled in the multicenter study for 5 years after successful IUS placement. This included 146 women aged 36−45 years who received the IUS for safety evaluation only, and 1,568 women aged 16−35 years who were evaluated for both safety and efficacy.¹

Results of the study

The 16−35-year-old participants included 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among these participants, 9 pregnancies occurred, including 4 in nulliparous women and 1 in an obese woman. In this age group, 1 pregnancy occurred after perforation and 1 following expulsion. Six (67%) of the pregnancies were ectopic.¹

The Pearl Index in the first year was .15 (95% confidence interval [CI], .02−.55). Cumulative life-table pregnancy rates at the end of years 3 and 5 were .59 (95% CI, .28−1.25) and .92 (95% CI, .46–1.82), respectively.¹

Of the total participants, perforation occurred in 2 (0.1%) women, both within the first year. Expulsion occurred in 63 participants (3.7%), most (50 [80.6%]) during the first year. Eleven patients (0.6%) were found to have a pelvic infection. Thirty-nine women (2.3%) discontinued use of Liletta due to bleeding complaints, primarily (n = 29 [74.3%]) in the first year.¹

Conclusion

The researchers concluded that Liletta is highly effective and has an excellent safety profile over 5 years of use. Most adverse effects, including expulsion and discontinuation for bleeding, occurred during the first year.¹

References

Teal SB, Turok DK, Jensen JT, Chen BA, Kimble TD, Creinin MD. Five-year efficacy and safety of the Liletta^®Levonorgestrel Intrauterine System. Obstet Gynecol. 2018;131(5 suppl):66S−67S.

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Deborah Reale, Managing Editor

Author(s)

Deborah Reale, Managing Editor

Liletta, a levonorgestrel 52 mg contraceptive intrauterine system (IUS) (Allergan), is currently approved by the US Food and Drug Administration for up to 4 years of use. A multicenter trial is continuing to measure Liletta’s efficacy and safety for a total of 8 years of use.¹

Meanwhile, investigators led by Stephanie B. Teal, MD, from the University of Colorado, Aurora, have evaluated the 5-year data for Liletta. Researchers included David K. Turok, MD, from the University of Utah, Salt Lake City; Jeffrey T. Jensen, MD, from the Oregon Health & Science University, Portland; Beatrice A. Chen, MD, from the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Thomas D. Kimble, MD, from Eastern Virginia Medical School, Norfolk; and Mitchell D. Creinin, MD, from the University of California-Davis, Sacramento. Results were reported in a poster presentation at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists held in Austin, Texas, from April 27–30, 2018.¹

Study details

A total of 1,714 women aged 16−45 years were enrolled in the multicenter study for 5 years after successful IUS placement. This included 146 women aged 36−45 years who received the IUS for safety evaluation only, and 1,568 women aged 16−35 years who were evaluated for both safety and efficacy.¹

Results of the study

The 16−35-year-old participants included 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among these participants, 9 pregnancies occurred, including 4 in nulliparous women and 1 in an obese woman. In this age group, 1 pregnancy occurred after perforation and 1 following expulsion. Six (67%) of the pregnancies were ectopic.¹

The Pearl Index in the first year was .15 (95% confidence interval [CI], .02−.55). Cumulative life-table pregnancy rates at the end of years 3 and 5 were .59 (95% CI, .28−1.25) and .92 (95% CI, .46–1.82), respectively.¹

Of the total participants, perforation occurred in 2 (0.1%) women, both within the first year. Expulsion occurred in 63 participants (3.7%), most (50 [80.6%]) during the first year. Eleven patients (0.6%) were found to have a pelvic infection. Thirty-nine women (2.3%) discontinued use of Liletta due to bleeding complaints, primarily (n = 29 [74.3%]) in the first year.¹

Conclusion

The researchers concluded that Liletta is highly effective and has an excellent safety profile over 5 years of use. Most adverse effects, including expulsion and discontinuation for bleeding, occurred during the first year.¹

Liletta, a levonorgestrel 52 mg contraceptive intrauterine system (IUS) (Allergan), is currently approved by the US Food and Drug Administration for up to 4 years of use. A multicenter trial is continuing to measure Liletta’s efficacy and safety for a total of 8 years of use.¹

Meanwhile, investigators led by Stephanie B. Teal, MD, from the University of Colorado, Aurora, have evaluated the 5-year data for Liletta. Researchers included David K. Turok, MD, from the University of Utah, Salt Lake City; Jeffrey T. Jensen, MD, from the Oregon Health & Science University, Portland; Beatrice A. Chen, MD, from the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Thomas D. Kimble, MD, from Eastern Virginia Medical School, Norfolk; and Mitchell D. Creinin, MD, from the University of California-Davis, Sacramento. Results were reported in a poster presentation at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists held in Austin, Texas, from April 27–30, 2018.¹

Study details

A total of 1,714 women aged 16−45 years were enrolled in the multicenter study for 5 years after successful IUS placement. This included 146 women aged 36−45 years who received the IUS for safety evaluation only, and 1,568 women aged 16−35 years who were evaluated for both safety and efficacy.¹

Results of the study

The 16−35-year-old participants included 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among these participants, 9 pregnancies occurred, including 4 in nulliparous women and 1 in an obese woman. In this age group, 1 pregnancy occurred after perforation and 1 following expulsion. Six (67%) of the pregnancies were ectopic.¹

The Pearl Index in the first year was .15 (95% confidence interval [CI], .02−.55). Cumulative life-table pregnancy rates at the end of years 3 and 5 were .59 (95% CI, .28−1.25) and .92 (95% CI, .46–1.82), respectively.¹

Of the total participants, perforation occurred in 2 (0.1%) women, both within the first year. Expulsion occurred in 63 participants (3.7%), most (50 [80.6%]) during the first year. Eleven patients (0.6%) were found to have a pelvic infection. Thirty-nine women (2.3%) discontinued use of Liletta due to bleeding complaints, primarily (n = 29 [74.3%]) in the first year.¹

Conclusion

The researchers concluded that Liletta is highly effective and has an excellent safety profile over 5 years of use. Most adverse effects, including expulsion and discontinuation for bleeding, occurred during the first year.¹

References

Teal SB, Turok DK, Jensen JT, Chen BA, Kimble TD, Creinin MD. Five-year efficacy and safety of the Liletta^®Levonorgestrel Intrauterine System. Obstet Gynecol. 2018;131(5 suppl):66S−67S.

References

Teal SB, Turok DK, Jensen JT, Chen BA, Kimble TD, Creinin MD. Five-year efficacy and safety of the Liletta^®Levonorgestrel Intrauterine System. Obstet Gynecol. 2018;131(5 suppl):66S−67S.

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OBG Management - 30(5)

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OBG Management - 30(5)

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