Farr G, Gabelnick H, Sturgen K, Dorflinger L
Clinical Trials Division, Family Health International, Research Triangle Park, NC 27709.
Am J Public Health. 1994 Dec;84(12):1960-4. doi: 10.2105/ajph.84.12.1960.
The purpose of the study was to determine the contraceptive efficacy of the female condom and to provide data about the device to the US Food and Drug Administration.
The clinical trial was conducted at six US sites and three sites in Latin America. Eligible subjects were in mutually monogamous relationships and agreed to use the female condom as their only means of contraception for 6 months.
A total of 328 subjects contributed to the analysis of contraceptive efficacy. Twenty-two US subjects and 17 Latin American subjects became pregnant, yielding 6-month gross cumulative accidental pregnancy rates of 12.4 and 22.2, respectively. During perfect (consistent and correct) use of the method, the 6-month accidental pregnancy rates were 2.6 and 9.5 for the US and Latin American centers, respectively. There were no serious adverse events related to the use of the method.
The female condom provides contraceptive efficacy in the same range as other barrier methods, particularly when used consistently and correctly, and has the added advantage of helping protect against sexually transmitted diseases.
本研究旨在确定女用避孕套的避孕效果，并向美国食品药品监督管理局提供有关该器械的数据。
临床试验在美国的六个地点和拉丁美洲的三个地点进行。符合条件的受试者处于相互一夫一妻制关系，并同意将女用避孕套作为其唯一避孕方式使用6个月。
共有328名受试者参与了避孕效果分析。22名美国受试者和17名拉丁美洲受试者怀孕，6个月的总累积意外怀孕率分别为12.4和22.2。在完美（持续且正确）使用该方法期间，美国和拉丁美洲中心的6个月意外怀孕率分别为2.6和9.5。未发生与使用该方法相关的严重不良事件。
女用避孕套的避孕效果与其他屏障方法相当，特别是在持续且正确使用时，并且具有有助于预防性传播疾病的额外优势。
