Failure Rates for Female Condom Are Moderate; Incorrect Use Is Common

Abstract

A six-month clinical trial of the female condom revealed failure rates of 12/100 users in the US and 22/100 users in Latin America. However among women who used the method consistently and correctly these rates were 3/100 and 10/100 respectively. The trial involved a total of 377 women 18-40 years of age recruited from six sites in the US and three in Latin America. Included among the stringent entry requirements were involvement in an ongoing monogamous relationship and a commitment to use the female condom as the only method of contraception for the six-month study period. US women were older more educated and significantly more likely to have previous experience with a barrier method than their Latin American counterparts. The contraceptive efficacy data were based on the 328 women who used the method at least once and returned for a minimum of one follow-up examination. 34% of the US women and 55% of those at the Latin American sites dropped out of the study before the six-month limit. Dislike of the device end of the sexual relationship or pregnancy were the most frequent reasons for study discontinuation. Of the 39 pregnancies recorded during the trial 24 were considered user failures. 62% of US and 70% of Latin American women acknowledged that they did not use the method as directed and 57% and 62% respectively did not use the condom at every act of intercourse. 45% of US women and 62% of Latin American women indicated a willingness to use female condoms in the future however and more than 80% indicated they would recommend the method to friends.