CONTRACEPTIVE EFFICACY AND ACCEPTABILITY OF THE FEMALE CONDOM

Objectives. The purpose of the study was to determine the contraceptiv e efficacy of the female condom and to provide data about the device t o the US Food and Drug Administration. Methods. 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 t he female condom as their only means of contraception for 6 months. Re sults. A total of 328 subjects contributed to the analysis of contrace ptive efficacy. Twenty-two US subjects and 17 Latin American subjects became pregnant, yielding 6-month gross cumulative accidental pregnanc y rates of 12.4 and 22.2, respectively. During perfect (consistent and correct) use of the method, the 6-month accidental pregnancy rates we re 2.6 and 9.5 for the US and Latin American centers, respectively. Th ere were no serious adverse events related to the use of the method. C onclusions. The female condom provides contraceptive efficacy in the s ame range as other barrier methods, particularly when used consistentl y and correctly, and has the added advantage of helping protect agains t sexually transmitted diseases.