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

Objective: This multisite, randomized, crossover trial comparing the performance of the Reality (R) 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. (c) 2006 Elsevier Inc. All rights reserved.