Efficacy, tolerability and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol

被引:179
作者
Roumen, FJME
Apter, D
Mulders, TMT
Deiben, TOM
机构
[1] Atrium Med Cent, Dept Obstet & Gynecol, NL-6401 CX Heerlen, Netherlands
[2] Vaestoliitto, Dept Gynecol, Helsinki, Finland
[3] NV Organon, Clin Dev Dept, NL-5340 BH Oss, Netherlands
关键词
acceptability; efficacy; ethinyl oestradiol; etonogestrel; vaginal ring;
D O I
10.1093/humrep/16.3.469
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
A novel contraceptive vaginal ring releasing etonogestrel 120 mug and ethinyl oestradiol 15 mug daily over a period of 3 weeks was tested. Each ring was used for one cycle, comprising 3 weeks of ring use followed by a 1 week ring-free period, This 1 year, multicentre study assessed the contraceptive efficacy, cycle control, tolerability and acceptability of the contraceptive. Altogether, 1145 women were exposed to the vaginal ring for 12 109 cycles (928 woman-years). Six pregnancies occurred during treatment, giving a Pearl Index of 0.65 (95% confidence interval 0.24-1.41). Cycle control was very good, since irregular bleeding was rare (2.6-6.4% of evaluable cycles) and withdrawal bleeding (mean duration 4.7-5.3 days) occurred in 97.9-99.4% of evaluable cycles, Compliance to the prescribed regimen was high with criteria being fulfilled in 90.8% of cycles. The ring was well tolerated. The majority of women considered this new contraceptive method easy to use, and it offers an effective, convenient, well-accepted and novel method for hormonal contraception.
引用
收藏
页码:469 / 475
页数:7
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