Eisenberg David L, Schreiber Courtney A, Turok David K, Teal Stephanie B, Westhoff Carolyn L, Creinin Mitchell D
Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Contraception. 2015 Jul;92(1):10-6. doi: 10.1016/j.contraception.2015.04.006. Epub 2015 Apr 28.
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.
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.
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.
The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women.
A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years.
评估一种新的52毫克左炔诺孕酮宫内节育器（LNG20）长达7年使用期的3年疗效和安全性数据。
纳入年龄在16 - 45岁、月经周期规律且要求避孕的未生育和已生育女性，进行一项开放标签、部分随机的试验以评估LNG20。主要结局是16 - 35岁女性的妊娠率，以Pearl指数计算。36 - 45岁女性仅接受LNG20用于安全性评估。在研究期间，所有参与者大约每3个月进行一次面对面或电话随访。
共有1600名16 - 35岁女性和151名36 - 45岁女性同意放置LNG20，其中包括1011名（57.7%）未生育女性和438名（25.1%）肥胖女性。1714名（97.9%）女性成功放置。发生了6次妊娠，其中4次为异位妊娠。LNG20在第1年的Pearl指数为0.15（95%可信区间0.02 - 0.55），第2年为0.26（95%可信区间0.10 - 0.57），第3年为0.22（95%可信区间0.08 - 0.49）。3年的累积生命表妊娠率为0.55（95%可信区间0.24 - 1.23）。62名（3.5%）参与者报告有节育器排出，大多数（50名[80.6%]）发生在使用的第1年。在停止使用LNG20且希望怀孕的女性中，86.8%在12个月内自然受孕。10名（0.6%）女性被诊断为盆腔感染。只有26名（1.5%）LNG20使用者因出血问题而停用。
LNG20宫内节育系统在未生育和已生育女性中使用3年具有高效性和安全性。
一种新的释放52毫克左炔诺孕酮的宫内节育系统对未生育和已生育女性至少3年有效且安全。
