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Hum. Reprod. Advance Access first published online on June 8, 2006
This version published online on June 12, 2006
Human Reproduction, doi:10.1093/humrep/del162
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© The Author 2006. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that: the original authorship is properly and fully attributed; the Journal and Oxford University Press are attributed as the original place of publication with the correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org
Received February 7, 2006
Revised April 12, 2006
Accepted April 19, 2006

Article

Effects on cycle control and bodyweight of the combined contraceptive ring, NuvaRing, versus an oral contraceptive containing 30 µg ethinyl estradiol and 3 mg drospirenone

I. Milsom 1 *, I. Lete 2, A. Bjertnaes 3, K. Rokstad 4, I. Lindh 1, C.J. Gruber 5, M.H. Birkhäuser 6, E. Aubeny 7, T. Knudsen 8, and C. Bastianelli 9

1 Department of Obstetrics and Gynaecology, Sahlgrenska Academy at Göteborg University, Göteborg, Sweden
2 Gynaecology Department, Santiago Hospital, Vitoria, Alava, Spain
3 Risvollan Legesenter as, Trondheim
4 Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway
5 Department of Gynaecological Endocrinology and Reproductive Medicine, University of Vienna Medical School, Vienna, Austria
6 Division of Gynaecological Endocrinology and Reproductive Medicine, University of Berne, Berne, Switzerland
7 French Association for Contraception, Paris, France
8 Søndergade, Haverslev, Nørager, Denmark
9 Department of Gynaecolgy, Perinatology and Childcare, University of Rome La Sapienza, Rome, Italy

* To whom correspondence should be addressed.
I. Milsom, E-mail: ian.milsom{at}obgyn.gu.se


  Abstract

BACKGROUND: The objective of this study was to compare cycle control, cycle-related characteristics and bodyweight effects of NuvaRing with those of a combined oral contraceptive (COC) containing 30 µg of ethinyl estradiol and 3 mg of drospirenone. METHODS: A randomized, multicentre, open-label trial in which 983 women were treated (intent-to-treat population) with NuvaRing or the COC for 13 cycles. RESULTS: Breakthrough bleeding or spotting during cycles 2-13 was in general less frequent with NuvaRing than that with the COC (4.7-10.4%) and showed a statistically significant odds ratio of 0.61 (95% confidence interval: 0.46, 0.80) with longitudinal analysis. Intended bleeding was significantly better for all cycles with NuvaRing (55.2-68.5%) than that with the COC (35.6-56.6%) (P < 0.01). Changes from baseline in mean bodyweight and body composition parameters were relatively small for both groups with no notable between-group differences. CONCLUSION: NuvaRing was associated with better cycle control than the COC, and there was no clinically relevant difference between the two groups in bodyweight.

Keywords: combined contraceptive vaginal ring/combined oral contraceptive/cycle control/irregular bleeding.
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