Abstract

PIP: A 6-month clinical trial on the effectiveness of the Realty female condom involving 377 women in the United States and Latin America ascertained that its failure rate was similar to that of other barrier methods. The cumulative pregnancy rates were 12.4% in the US 22.2% in Latin America. Among the 262 American women using the condom correctly the failure rate was only 2.6%; among the 115 Latin American women the perfect-use failure rate was 9.5% at the end of 6 months. The difference in pregnancy rates was probably due to the different characteristics of the two groups of women, since Latin American women had little previous experience with barrier methods. They were also younger and more parous than the American women. 12 of the 39 pregnancies were classified as method failures and 24 as user failures. The overall rate of use-effectiveness compared favorably with that of the cervical cap, the contraceptive sponge, and the diaphragm with spermicide reported for US women. The US Food and Drug Administration doubled the 13% 6-month failure rate to come up with a 26% 12-month failure rate for the female condom. However, British scientists studying the British version, Femidom, based on a 1988 12-month contraceptive efficacy study, found a 15% failure among 100 women studied. During 437 cumulative months of use, 7 accidental pregnancies occurred, 4 of which were related to inconsistent use. The majority of British women did not like the product, however, more than 80% of the American and Latin American women liked it and would recommend it to others. Complaints included dislike of the inner ring, inconvenience, and messiness. Nevertheless, 45% of the American women and 62% of the Latin American women indicated that they would like to use the condom in the future for contraception.