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一种避孕阴道环(优思明阴道环)与复方口服避孕药相比的有效性和安全性:一项为期1年的随机试验。

Efficacy and safety of a contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive: a 1-year randomized trial.

作者信息

Oddsson Kristjan, Leifels-Fischer Beate, de Melo Nilson Roberto, Wiel-Masson Dominique, Benedetto Chiara, Verhoeven Carole H J, Dieben Thom O M

机构信息

Idungården Legesenter, Olav Tryggvasonsgate 24c, NO-7011 Norway.

出版信息

Contraception. 2005 Mar;71(3):176-82. doi: 10.1016/j.contraception.2004.09.001.

Abstract

This open-label, randomized, Phase III study compared the efficacy and tolerability of and compliance with NuvaRing, a combined contraceptive vaginal ring releasing 15 microg of ethinylestradiol (EE) and 120 microg of etonogestrel daily, with those of and with a combined oral contraceptive (COC) containing 150 microg of levonorgestrel (LNG) and 30 microg of EE. Subjects received NuvaRing or a COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-/pill-free period). A total of 1030 subjects (NuvaRing, n=512; COC, n=518) was randomized and started treatment (intent-to-treat [ITT] population). The percentage of women in the ITT population who completed the trial was 70.9% for the NuvaRing group and 71.2% for the COC group. Five in-treatment pregnancies occurred in each group, giving Pearl indices of 1.23 for NuvaRing and 1.19 for the COC. Compliance with both treatments was excellent and both were well tolerated. In conclusion, NuvaRing has comparable efficacy and tolerability with a COC containing 150 microg of LNG and 30 microg of EE and does not require daily dosing.

摘要

这项开放标签、随机、III期研究比较了复方避孕阴道环NuvaRing(每日释放15微克乙炔雌二醇[EE]和120微克依托孕烯)与含150微克左炔诺孕酮[LNG]和30微克EE的复方口服避孕药(COC)的疗效、耐受性和依从性。受试者接受NuvaRing或COC治疗13个周期(环/片治疗3周,随后是1周的无环/无片期)。共有1030名受试者(NuvaRing组n = 512;COC组n = 518)被随机分组并开始治疗(意向性治疗[ITT]人群)。ITT人群中完成试验的女性百分比,NuvaRing组为70.9%,COC组为71.2%。每组均发生5例治疗期间妊娠,NuvaRing组的Pearl指数为1.23,COC组为1.19。两种治疗方法的依从性都很好,耐受性也都良好。总之,NuvaRing与含150微克LNG和30微克EE的COC具有相当的疗效和耐受性,且无需每日给药。

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