Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 μg of ethinyl estradiol and 3 mg of drospirenone

Ahrendt, Hans-Joachim; Nisand, Israel; Bastianelli, Carlo; Gómez, Maria Angeles; Gemzell-Danielsson, Kristina; Urdl, Wolfgang; Karskov, Birgit; Oeyen, Luc; Bitzer, Johannes; Page, Geert; Milsom, Ian

doi:10.1016/j.contraception.2006.07.004

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Volume 74, Issue 6 , Pages 451-457, December 2006

Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 μg of ethinyl estradiol and 3 mg of drospirenone

Hans-Joachim Ahrendt
- Halberstädter Straβe 122, D-39112 Magdeburg, Germany
- Corresponding author. Tel.: +49 391 60 19 60; fax: +49 391 60 40 74.
Israel Nisand
- Department of Gynaecology and Obstetrics, Hautepierre Hospital, 67098 Strasbourg Cédex, France
Carlo Bastianelli
- Department of Gynaecolgy, Perinatology and Childcare, University of Rome La Sapienza, 00161 Rome, Italy
Maria Angeles Gómez
- Family Planning Centre, Valencian Health Agency, 03013 Alicante, Spain
Kristina Gemzell-Danielsson
- Division for Obstetrics and Gynaecology, Department of Woman and Child Health, Karolinska Institute, S-171 76 Stockholm, Sweden
Wolfgang Urdl
- Department of Obstetrics and Gynaecology, Medical University of Graz, 8036 Graz, Austria
Birgit Karskov
- Værløse Lægehus, Bymidten 39, 1, 3500 Værløse, Dk Denmark
Luc Oeyen
- Department of Gynecology, Saint Vincent Hospital, St. Vincentiusstraat 20, 2018 Antwerpen, Belgium
Johannes Bitzer
- Department of Obstetrics and Gynaecology, University of Basel, CH-4031 Basel, Switzerland
Geert Page
- Department of Obstetrics and Gynaecology, Gasthuisstraat 59, 8970 Poperinge, Belgium
Ian Milsom
- Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, SE-416 85 Göteborg, Sweden

Received 10 February 2006; received in revised form 25 July 2006; accepted 26 July 2006. published online 28 September 2006.

Abstract

Purpose

This randomized multicenter, open-label, trial compared efficacy, acceptability, tolerability and compliance of NuvaRing with a combined oral contraceptive (COC), containing 30 μg of ethinyl estradiol (EE) and 3 mg of drospirenone.

Method

In this 13-cycle study, 983 women were randomized and treated (intent-to-treat population) with NuvaRing or COC.

Results

One in-treatment pregnancy occurred with NuvaRing (Pearl Index=0.25) (95% confidence interval [CI]: 0.006, 1.363) and four with the COC (Pearl Index=0.99) (95% CI: 0.269, 2.530). For both groups, compliance (89.2% NuvaRing, 85.5% COC) and satisfaction (84% NuvaRing; 87% COC) were high; the vast majority of women found NuvaRing easy to insert (96%) and remove (97%). Tolerability was similar; the most frequent adverse events with NuvaRing were related to ring use, whereas estrogen-related events were more common with the COC.