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Hum. Reprod. Advance Access published online on November 11, 2004
Human Reproduction, doi:10.1093/humrep/deh604
© 2004 by European Society of Human Reproduction and Embryology
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Received August 13, 2004
Accepted October 15, 2004

Article

Superior cycle control with a contraceptive vaginal ring (NuvaRing) compared with an oral contraceptive containing 30 µg ethinylestradiol and 150 µg levonorgestrel: a randomized trial

K. Oddsson 1, B. Leifels-Fischer 2, D. Wiel-Masson 3, N.R. de Melo 4, C. Benedetto 5, C.H.J. Verhoeven 6, and T.O.M. Dieben 6*

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
6 Clinical Development Department, NV Organon, Oss, The Netherlands

* To whom correspondence should be addressed.
T.O.M. Dieben, E-mail: thom.dieben{at}organon.com


  Abstract

BACKGROUND: This trial was conducted to compare cycle control with NuvaRing, 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 NuvaRing or a COC for 13 cycles (12 months). RESULTS: A total of 1030 subjects (NuvaRing, 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 NuvaRing 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 NuvaRing (range 2.0-6.4%) than the COC (range 3.5-12.6%), and for cycles 2 and 9 the lower incidence with NuvaRing 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 NuvaRing (58.8-72.8%) than with the COC (43.4-57.9%). CONCLUSIONS: Cycle control with NuvaRing was excellent and superior to that of a COC containing 30 µg EE.

Keywords: contraceptive; cycle control; irregular bleeding; NuvaRing; superiority.
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