Contraceptive efficacy and acceptability of the female condom.

Abstract

OBJECTIVES. 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. 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 the female condom as their only means of contraception for 6 months. RESULTS. 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. CONCLUSIONS. 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.

Female-Initiated Barrier Methods for the Prevention of STI/HIV: Where Are We Now? Where Should We Go?

“…A Medline key word search of "female condom" at press time resulted in a listing of 123 articles on various aspects of safety, acceptability, and efficacy. While the first two have been well established 38,39 and rigorous studies on the contraceptive efficacy of the female condom have been done, [40][41][42] data on the efficacy against STI are limited, 43,44 and more studies, especially those involving long-term follow up, are needed.…”

Effectiveness of an intervention promoting the female condom to patients at sexually transmitted disease clinics

“…Research has confirmed the contraceptive efficacy of the female condom. 7,8 One study suggested prophylactic efficacy against vaginal trichomoniasis. 9 A study among commercial sex workers in Thailand suggested that adding the female condom as an option for protection decreases unprotected sex and STD incidence.…”

“…12,13 Although some of the studies with US women merely assessed acceptability with potential users, [14][15][16][17] most assessed acceptability after trial use. 7,[18][19][20][21][22] High rates of trial use and fairly positive reactions to the female condom have been reported. 7,18,19 Many acceptability studies have been criticized, however, as overestimating acceptability due to selection bias because the women had to agree to try the device as a criterion for study inclusion.…”

“…7,[18][19][20][21][22] High rates of trial use and fairly positive reactions to the female condom have been reported. 7,18,19 Many acceptability studies have been criticized, however, as overestimating acceptability due to selection bias because the women had to agree to try the device as a criterion for study inclusion. 22 Acceptability studies also assume that the product is the major determinant of acceptability.…”

Challenges to female condom integration into condom programming

“…In addition, of the 221 US women, 33.5% discontinued, whereas 55.1% of the 107 Latin American women discontinued. Overall the very limited evidence available indicates that the female condom, when used consistently and correctly, can be a highly effective method of contraception 14 .…”