Division of Family Planning, Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA.
Division of Family Planning, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.
Am J Obstet Gynecol. 2022 Dec;227(6):871.e1-871.e7. doi: 10.1016/j.ajog.2022.05.022. Epub 2022 May 13.
Extending hormonal intrauterine system duration will allow users to have less need for procedures to provide long-term contraception.
This study aimed to evaluate the efficacy and safety of the levonorgestrel 52 mg intrauterine system during years 7 and 8 of use.
A total of 1751 nulliparous and multiparous participants aged 16 to 45 years enrolled in a phase 3, multicenter trial to evaluate the efficacy and safety of the use of the Liletta levonorgestrel 52 mg intrauterine system for up to 10 years. Participants aged 36 to 45 years at enrollment underwent safety evaluation only. After the first year, we evaluated participants every 6 months for intrauterine system location confirmation and urine pregnancy testing at each visit. We assessed the Pearl Indices in years 7 and 8 and the life-table analysis for cumulative pregnancy rates through 8 years of use. For the primary efficacy analyses, all participants aged 16 to 35 years at enrollment were included through year 6; years 7 and 8 included only users aged ≤39 years at the start of each use year. Safety outcomes were assessed in all participants regardless of duration of use. We assessed amenorrhea rates, defined as no bleeding or spotting in the 90 days before the end of the year.
After intrauterine system placement, we followed 1568 participants aged 16 to 35 years and 146 participants aged 36 to 45 years. The 16- to 35-year-old participants included 986 (57.5%) nulliparous and 433 (25.3%) obese users. Overall, 569 participants started year 7, 478 completed year 7 (380 aged ≤39 years at beginning of year) and 343 completed year 8 (257 aged ≤39 years at beginning of year); 77 completed 10 years of use. Eleven pregnancies occurred over 8 years, 7 (64%) of which were ectopic. Two pregnancies occurred in year 7 (Pearl Index, 0.49; 95% confidence interval, 0.06-1.78), 1 in a participant with implantation 4 days after a desired removal; no pregnancies occurred in year 8. The cumulative life-table pregnancy rate in the primary efficacy population through year 8 was 1.32 (95% confidence interval, 0.69-2.51); without the postremoval pregnancy, the rate was 1.09 (95% confidence interval, 0.56-2.13). Two perforations (0.1%) occurred, none noted after year 1. Expulsion occurred in 71 (4.1%) participants overall, with 3 in year 7 and 2 in year 8. Pelvic infection was diagnosed in 16 (0.9%) participants during intrauterine system use, 1 each in years 7 and 8. Only 44 (2.6%) participants overall discontinued because of bleeding complaints (4 total in years 7 and 8) with rates per year of 0.1% to 0.5% for years 3 to 8. Amenorrhea rates were 39% at both years 7 and 8.
The levonorgestrel 52 mg intrauterine system is highly effective over 8 years of use and has an excellent extended safety profile. This report details the longest period of efficacy and safety data for continuous use of a levonorgestrel 52 mg intrauterine system for contraception.
延长激素宫内节育系统的使用期限将减少需要进行手术以提供长期避孕的需求。
本研究旨在评估左炔诺孕酮 52mg 宫内节育系统在使用 7 年和 8 年时的疗效和安全性。
共有 1751 名年龄在 16 至 45 岁的未产妇和经产妇参加了一项为期 3 年、多中心的试验，以评估 Liletta 左炔诺孕酮 52mg 宫内节育系统使用长达 10 年的疗效和安全性。36 至 45 岁的参与者仅接受安全性评估。第一年之后，我们每 6 个月评估一次宫内节育系统的位置确认和每次就诊时的尿妊娠试验。我们评估了第 7 年和第 8 年的 Pearl 指数和通过 8 年使用的累积妊娠率的生命表分析。对于主要疗效分析，所有年龄在 16 至 35 岁的参与者均在第 6 年结束前被纳入；第 7 年和第 8 年仅包括在每个使用年开始时年龄≤39 岁的使用者。无论使用期限如何，均评估了安全性结局。我们评估了闭经率，定义为在当年结束前的 90 天内没有出血或点滴出血。
宫内节育系统放置后，我们随访了 1568 名年龄在 16 至 35 岁的参与者和 146 名年龄在 36 至 45 岁的参与者。16 至 35 岁的参与者中，986 名（57.5%）为未产妇，433 名（25.3%）为肥胖者。总体而言，569 名参与者开始了第 7 年，478 名完成了第 7 年（开始时年龄≤39 岁的有 430 名），433 名完成了第 8 年（开始时年龄≤39 岁的有 257 名）；77 名完成了 10 年的使用。8 年内发生了 11 例妊娠，其中 7 例（64%）为异位妊娠。第 7 年发生了 2 例妊娠（Pearl 指数，0.49；95%置信区间，0.06-1.78），1 例发生在期望取出后 4 天；第 8 年未发生妊娠。主要疗效人群中，通过第 8 年的累积生命表妊娠率为 1.32（95%置信区间，0.69-2.51）；没有取出后妊娠，率为 1.09（95%置信区间，0.56-2.13）。发生了 2 例穿孔（0.1%），均未在第 1 年后发生。总体有 71 名（4.1%）参与者发生了脱落，其中 3 例发生在第 7 年，2 例发生在第 8 年。在宫内节育系统使用期间，有 16 名（0.9%）参与者被诊断为盆腔感染，每年各有 1 例发生在第 7 年和第 8 年。仅有 44 名（2.6%）参与者因出血投诉而总体停药（第 7 年和第 8 年总共 4 名），第 3 年至第 8 年每年的停药率为 0.1%至 0.5%。第 7 年和第 8 年的闭经率均为 39%。
左炔诺孕酮 52mg 宫内节育系统在使用 8 年期间具有高度有效性，且安全性得到了很好的扩展。本报告详细介绍了左炔诺孕酮 52mg 宫内节育系统连续使用最长时间的避孕效果和安全性数据。
