Comparative performance of ultra-thin and standard latex condoms: a randomized multi-centre trial.

Abstract

Objectives: This study aimed to assess the performance of a natural rubber latex (NRL) condom with thickness 42 µm, compared with two currently marketed alternatives.

Study design: In this blinded, three-way crossover, multi-centre study, across four sites in Thailand, couples were randomised to receive one of three thicknesses of condom (42 µm, 55 µm, or 70 µm) at first visit. Couples received the remaining condoms at visits two and three respectively. Participants were given seven condoms at each visit and asked to use at least five condoms of each thickness and report any clinical failures (slippage or breakage during intercourse or withdrawal from the vagina). Participants recorded adverse events and clinical failures within two hours of use.

Results: 225 couples completed the study. Clinical failure rates were 1.37% (95% confidence intervals [CI] 0.78, 2.22) in the 42 µm group, 2.12% (95% CI 1.38, 3.11) in the 55 µm group and 1.68% (95% CI 1.03, 2.58) in the 70 µm group. The 42 µm condom was non-inferior compared with each of the reference condoms and had a similar safety profile.

Conclusions: This ultra-thin, NRL condom of <50 µm has been clinically tested to current International Organization for Standardization (ISO) standards. The 42 µm condom was as effective as the 55 µm and 70 µm condoms, demonstrating that performance in terms of failure rate, slippage, or breakage was not altered by its thinness.