Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women.

Abstract Objective This multisite, randomized, crossover trial comparing the performance of the Reality® female condom (FC1) with a new synthetic latex prototype (FC2) was conducted in Durban, South Africa. Method In total, 276 women were enrolled and 201 women completed the study. Altogether, 1910 FC1 condoms and 1881 FC2 condoms were used. Results Total breakage was 0.73% in FC1 and 0.85% in FC2 (95% confidence interval, −0.64 to 0.87). The number of clinical breakages (those that could result in a pregnancy or sexually transmitted infection) was similar for each condom type (FC1, n =9; FC2, n =8). Incorrect penetration (penis between condom and vaginal wall) was 1.26% and 0.64% for FC1 and FC2, respectively. Outer ring displacements (outer ring pushed into the vagina partially or fully) were comparable for both condoms (FC1, 3.14%; FC2, 2.98%). Slippage (condom came out of the vagina) was rare and reported in 0.37% or less of devices used. Total clinical failure was 5.24% in FC1 and 4.3% in FC2. Conclusion The FC1 and FC2 performed comparably within this trial.