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Human Reproduction, Vol. 16, No. 3, 469-475, March 2001
© 2001 European Society of Human Reproduction and Embryology

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

F.J.M.E. Roumen1,,4, D. Apter2, T.M.T. Mulders3 and T.O.M. Dieben3

1 Atrium Medisch Centrum, Department of Obstetrics and Gynecology, Heerlen, The Netherlands, 2 Väestöliitto, Department of Gynecology, Helsinki, Finland and 3 Clinical Development Department, Contraception, NV Organon, Oss, The Netherlands

A novel contraceptive vaginal ring releasing etonogestrel 120 µg and ethinyl oestradiol 15 µg 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.

Key words: acceptability/efficacy/ethinyl oestradiol/etonogestrel/vaginal ring

4 To whom correspondence should be addressed at: Atrium Medisch Centrum, Department of Obstetrics and Gynecology, H. Dunantstraat 5, P.O.Box 4446, 6401 CX Heerlen, The Netherlands. E-mail: roumenfj{at}knmg.nl


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