Contraception. 1987 Apr;35(4):363-79.
An intrauterine device (IUD) releasing 2 micrograms of levonorgestrel per 24 hours was compared in a randomized multicentre clinical trial with two copper IUDs-the TCu 220C and the Nova T. The 2 micrograms levonorgestrel device had statistically significantly higher pregnancy rates (from 390 days of use) and higher expulsion rates (up to 570 days). In addition, the total medical removals and removals for bleeding were significantly higher at all intervals where the data were analysed. Most disturbing was a 6.7 increased relative risk of ectopic pregnancy with the steroid-releasing IUD compared to the combined copper IUD data. It is concluded that the goal of microdose administration of 2 micrograms levonorgestrel to the uterine cavity does not achieve the objectives of a new and improved IUD device which is safe and effective.
在一项随机多中心临床试验中,将一种每24小时释放2微克左炔诺孕酮的宫内节育器(IUD)与两种铜质IUD(TCu 220C和Nova T)进行了比较。每24小时释放2微克左炔诺孕酮的IUD在统计学上具有显著更高的妊娠率(使用390天后)和更高的脱落率(长达570天)。此外,在所有进行数据分析的时间段内,因医疗原因的取出总数以及因出血而取出的比例均显著更高。最令人不安的是,与联合铜质IUD的数据相比,释放类固醇的IUD使异位妊娠的相对风险增加了6.7倍。得出的结论是,向子宫腔微量给药2微克左炔诺孕酮的目标未能实现一种安全有效的新型改良IUD装置的目标。