David L Eisenberg1, Courtney A Schreiber2, David K Turok3, Stephanie B Teal4, Carolyn L Westhoff5, Mitchell D Creinin6. 1. Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO, USA. 2. Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 3. Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, USA. 4. Department of Obstetrics and Gynecology, University of Colorado, Aurora, CO, USA. 5. Department of Obstetrics and Gynecology and Department of Epidemiology, Columbia University, New York, NY, USA. 6. Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA. Electronic address: mitchell.creinin@ucdmc.ucdavis.edu.
Abstract
OBJECTIVE: To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive (LNG20) designed for up to 7 years use. STUDY DESIGN:Nulliparous and parous women aged 16-45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label, partially randomized trial to evaluate LNG20. The primary outcome was pregnancy rate for womenaged 16-35 years calculated as the Pearl Index. Women aged 36-45 years receivedLNG20 for safety evaluation only. All participants had in-person or phone follow-up approximately every 3 months during the study. RESULTS: A total of 1600 women aged 16-35 years and 151 women aged 36-45 years agreed to LNG20 placement, including 1011 (57.7%) nulliparous and 438 (25.1%) obese women. Successful placement occurred in 1714 (97.9%) women. Six pregnancies occurred, four of which were ectopic. The Pearl Index for LNG20 was 0.15 (95% CI 0.02-0.55) through Year 1, 0.26 (95% CI 0.10-0.57) through Year 2, and 0.22 (95% CI 0.08-0.49) through Year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI 0.24-1.23) through 3 years. Expulsion was reported in 62 (3.5%) participants, most (50 [80.6%]) during the first year of use. Of women who discontinued LNG20 and desired pregnancy, 86.8% conceived spontaneously within 12 months. Pelvic infection was diagnosed in 10 (0.6%) women. Only 26 (1.5%) LNG20 users discontinued due to bleeding complaints. CONCLUSION: The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women. IMPLICATIONS STATEMENT: A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years.
RCT Entities:
OBJECTIVE: To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive (LNG20) designed for up to 7 years use. STUDY DESIGN: Nulliparous and parous women aged 16-45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label, partially randomized trial to evaluate LNG20. The primary outcome was pregnancy rate for women aged 16-35 years calculated as the Pearl Index. Women aged 36-45 years received LNG20 for safety evaluation only. All participants had in-person or phone follow-up approximately every 3 months during the study. RESULTS: A total of 1600 women aged 16-35 years and 151 women aged 36-45 years agreed to LNG20 placement, including 1011 (57.7%) nulliparous and 438 (25.1%) obesewomen. Successful placement occurred in 1714 (97.9%) women. Six pregnancies occurred, four of which were ectopic. The Pearl Index for LNG20 was 0.15 (95% CI 0.02-0.55) through Year 1, 0.26 (95% CI 0.10-0.57) through Year 2, and 0.22 (95% CI 0.08-0.49) through Year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI 0.24-1.23) through 3 years. Expulsion was reported in 62 (3.5%) participants, most (50 [80.6%]) during the first year of use. Of women who discontinued LNG20 and desired pregnancy, 86.8% conceived spontaneously within 12 months. Pelvic infection was diagnosed in 10 (0.6%) women. Only 26 (1.5%) LNG20 users discontinued due to bleeding complaints. CONCLUSION: The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women. IMPLICATIONS STATEMENT: A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years.
Authors: Lauryn P Roth; Jessica N Sanders; Rebecca G Simmons; Holly Bullock; Elizabeth Jacobson; David K Turok Journal: Contraception Date: 2018-03-21 Impact factor: 3.375
Authors: Melissa C Matulich; Melissa J Chen; Natasha R Schimmoeller; Jennifer K Hsia; Suji Uhm; Machelle D Wilson; Mitchell D Creinin Journal: Obstet Gynecol Date: 2019-10 Impact factor: 7.661