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

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• 作者：Hans-Joachim Ahrendt ; Israel Nis ; Carlo Bastianelli ; Maria Angeles Gó ; mez ; Kristina Gemzell-Danielsson ; Wolfgang Urdl ; Birgit Karskov ; Luc Oeyen ; Johannes Bitzer ; Geert Page ; et al.
• 关键词：NuvaRing ; Contraceptive ; Compliance ; Efficacy ; Tolerability ; Pill
• 刊名：Contraception
• 出版年：2006
• 期刊代码：71_00107824
• 类别：med
• 出版时间：December 2006
• 卷：74
• 期：6
• 页码：451-457
• 文件大小：270 K

摘要

>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.

Conclusion

NuvaRing has comparable efficacy and tolerability to a COC containing 30 μg of EE and 3 mg drospirenone. User acceptability of both methods was high.