Although millions of couples rely on male latex condoms to protect against unintended pregnancy and sexually transmitted infections, their use is limited in part by questions about their performance. Rates of condom breakage and slippage, two measures of performance, vary broadly across studies. This variation in part reflects study variability and limitations, including sample size, reliance on subjects' memory, user populations, and products evaluated. In an effort to define condom performance in a group of monogamous couples typical of those using condoms for contraception, we conducted a clinical trial of a single brand of lubricated condoms (Durex Ramses). A total of 4637 attempts to use the condom were evaluated. Six breaks occurred before intercourse (nonclinical breaks), and 10 condoms broke during intercourse or were only noted to have broken upon withdrawal (clinical breaks), resulting in a nonclinical breakage rate of 0.13% (95% confidence interval, 0.05-0.28%), clinical breakage rate of 0.28% (0.15-0.48%), and a total breakage rate of 0.41% (0.25-0.64%). The rate of complete slippage was 0.63% (0.42-0.90%), and total failure (clinical breaks plus complete slips) was 1.04% (0.76-1.37%). These rates are lower than those in other studies with the exception of one, a prospective investigation in a population of female prostitutes. Results indicate that condoms can, in experienced, motivated populations, provide excellent performance and suggest that their efficacy at preventing pregnancy may equal that of the most reliable forms of contraception. Because this study involved a single condom brand, these results may not be generalizable to other brands.
PIP: Rates of condom slippage and breakage were recorded for 4637 attempts to use the condom during sexual intercourse by 92 monogamous couples who had sex at least 8 times per month and had no history of fertility-impairing conditions, including sexually transmitted infections. The couples were comprised of men age 18-50 years and women age 18-40 years. They were at risk of pregnancy, and condoms were their sole method of birth control during the study. Lubricated Durex Ramses condoms were tested in this clinical trial. The men and women were of mean ages 28.8 and 26.8 years, respectively, 75.0% White, and either married or never married in approximately equal proportions. Nearly all participants completed high school and 75% lived with their current partner or spouse. 70-75% were experienced condom users, having used a condom more than 50 times with their current partner. 6 breaks occurred before intercourse and 10 condoms broke during intercourse or were noted to have broken upon withdrawal. These breakages amount to a nonclinical breakage rate of 0.13%, a clinical breakage rate of 0.28%, and a total breakage rate of 0.41%. No breakage or slippage occurred during the 4 reported acts of anal intercourse. The rate of complete slippage was 0.63% and total failure, clinical breaks plus complete slips, was 1.04%. These rates are lower than those in other studies except for 1 prospective study in a population of female prostitutes.