Hum. Reprod. Advance Access originally published online on November 11, 2004
Human Reproduction 2005 20(2):557-562; doi:10.1093/humrep/deh604
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Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 µg ethinylestradiol and 150 µg levonorgestrel: a randomized trial
1 Women's Health Associates, Kopavogur, Iceland, 2 Birnauer Srasse, Munich, Germany, 3 Boulevard Chasles, Chartres, France, 4 Department of Gynaecology and Obstetrics, Hospital das Clínicas of São Paulo University, Brazil, 5 Department of Obstetrics and Gynecology, University of Turin, Italy and 6 Clinical Development Department, NV Organon, Oss, The Netherlands
7 To whom correspondence should be addressed at: NV Organon, Clinical Development Department, P.O.Box 20, 5340 BH Oss, The Netherlands. Email: thom.dieben{at}organon.com
BACKGROUND: This trial was conducted to compare cycle control with vaginal ring a combined contraceptive vaginal ring, and a combined oral contraceptive (COC) delivering 30 µg ethinylestradiol (EE) and 150 µg levonorgestrel. METHODS: This open-label, randomized, multi-centre, Phase III study involved adult women from 11 countries. Subjects were treated with either vaginal ring or a COC for 13 cycles (12 months). RESULTS: A total of 1030 subjects (vaginal ring, n=512; COC, n=518) comprised the intention-to-treat (ITT) population. The percentage of women in the ITT population who completed the trial was 70.9% for vaginal ring and 71.2% for the COC group. The incidence of breakthrough bleeding and spotting over cycles 2–13, the primary efficacy parameter, was lower with vaginal ring (range 2.0–6.4%) than the COC (range 3.5–12.6%), and for cycles 2 and 9 the lower incidence with vaginal ring was confirmed as statistically significant (P=0.003 and P=0.002 respectively). The incidence of intended bleeding was significantly higher over all cycles with vaginal ring (58.8–72.8%) than with the COC (43.4–57.9%). CONCLUSIONS: Cycle control with vaginal ring was excellent and superior to that of a COC containing 30 µg EE.
Key words: contraceptive/cycle control/irregular bleeding/NuvaRing/superiority
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