Effectiveness of female and male condoms in preventing exposure to semen during vaginal intercourse: a randomized trial.

OBJECTIVES Comparison of male condom (MC) vs. female condom (FC) with respect to self-reported mechanical and acceptability problems and semen exposure using prostate-specific antigen (PSA) as an objective biological marker and evaluation of the effect of an educational intervention on self-reported problems and semen exposure, by condom type. DESIGN Randomized crossover trial. METHODS Four hundred women attending a family planning clinic in Brazil were randomized and either received in-clinic instruction or were encouraged to read the condom package insert; all used two FCs and two MCs. We measured the rates of self-reported user problems with MC and FC use and the rates of semen exposure during use (assessed by testing vaginal fluid for PSA). RESULTS The educational intervention group reported fewer problems with either condom as compared with the control group (p = .0004, stratified by condom type). In both groups, self-reported problems were more frequent with FC use than with MC use (p < .0001, stratified by intervention). The educational intervention did not significantly reduce semen exposure. Overall, semen exposure occurred more frequently with FC use (postcoital PSA, > 1 ng/mL; 22%) than with MC use (15%); the difference, however, was small and nonsignificant for high PSA levels (> or = 150 ng/mL; 5.1% for FC vs. 3.6% for MC). CONCLUSIONS In this study, the FC was less effective than the MC in preventing semen exposure during use and led more frequently to self-reported user problems. Both devices were highly protective against "high-level" semen exposure, as measured by postcoital PSA levels in vaginal fluid. In-clinic education may reduce user problems and increase acceptability and use of both devices.