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

被引:107
|
作者
Ahrendt, Hans-Joachim
Nisand, Israel
Bastianelli, Carlo
Gomez, Maria Angeles
Gemzell-Danielsson, Kristina
Urdl, Wolfgang
Karskov, Birgit
Oeyen, Luc
Bitzer, Johannes
Page, Geert
Milsom, Ian
机构
[1] Hautepoerre hosp, Dept Obstet & Gynaecol, F-67098 Strasbourg, France
[2] Univ Roma Tor Vergata, Dept Gynaecol Perinatol & Childcare, I-00161 Rome, Italy
[3] Valencian Hlth Agcy, Family Planning Ctr, Alicante 03013, Spain
[4] Karolinska Inst, Dept Woman & Child Hlth, Div Obstet & Gynaecol, S-17176 Stockholm, Sweden
[5] Med Univ Graz, Dept Obstet & Gynaecol, A-8036 Graz, Austria
[6] Voerlose Loegehus, DK-3500 Voerlose DK, Denmark
[7] St Vincents Hosp, Dept Gynecol, B-2018 Antwerp, Belgium
[8] Univ Basel, Dept Obstet & Gynaecol, CH-4031 Basel, Switzerland
[9] Dept Obstet & Gynaecol, B-8970 Poperinge, Belgium
[10] Sahlgrens Univ Hosp, Dept Obstet & Gynaecol, SE-41286 Gothenburg, Sweden
关键词
NuvaRing; contraceptive; compliance; efficacy; tolerability; pill;
D O I
10.1016/j.contraception.2006.07.004
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
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 mu g 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 [Cl]: 0.006, 1.363) and four with the COC (Pearl Index=0.99) (95% Cl: 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 mu g of EE and 3 mg drospirenone. User acceptability of both methods was high. (c) 2006 Elsevier Inc. All rights reserved.
引用
收藏
页码:451 / 457
页数:7
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