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
Halberstädter Strasse 122, D-39112 Magdeburg, Germany.
Contraception. 2006 Dec;74(6):451-7. doi: 10.1016/j.contraception.2006.07.004. Epub 2006 Sep 27.
This randomized multicenter, open-label, trial compared efficacy, acceptability, tolerability and compliance of NuvaRing with a combined oral contraceptive (COC), containing 30 microg of ethinyl estradiol (EE) and 3 mg of drospirenone.
In this 13-cycle study, 983 women were randomized and treated (intent-to-treat population) with NuvaRing or COC.
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.
NuvaRing has comparable efficacy and tolerability to a COC containing 30 microg of EE and 3 mg drospirenone. User acceptability of both methods was high.
本随机、多中心、开放标签试验比较了优思明与含30微克炔雌醇（EE）和3毫克屈螺酮的复方口服避孕药（COC）的疗效、可接受性、耐受性和依从性。
在这项为期13个周期的研究中，983名女性被随机分组，接受优思明或COC治疗（意向性治疗人群）。
使用优思明发生1例治疗期间妊娠（Pearl指数=0.25）（95%置信区间[CI]：0.006，1.363），使用COC发生4例（Pearl指数=0.99）（95%CI：0.269，2.530）。两组的依从性（优思明89.2%，COC 85.5%）和满意度（优思明84%；COC 87%）都很高；绝大多数女性发现优思明易于插入（96%）和取出（97%）。耐受性相似；优思明最常见的不良事件与环的使用有关，而与雌激素相关的事件在COC中更常见。
优思明与含30微克EE和3毫克屈螺酮的COC具有相当的疗效和耐受性。两种方法的用户接受度都很高。
