Contraception · 2025
Comparative performance of ultrathin and standard latex condoms: A randomized multicentre trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Esclassan Frederic, Tank Nina, Switonski Alice, Steiner Markus J, Hood Sarah, Jaisamrarn Unnop
Аннотация
OBJECTIVES: This study aimed to assess the performance of a natural rubber latex condom with a thickness of 42 µm, compared with two currently marketed alternatives.
STUDY DESIGN: In this blinded, three-way crossover, multicentre study, across four sites in Thailand, couples were randomized to receive one of three thicknesses of condom (42, 55, 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 2 hours of use.
RESULTS: A total of 225 couples completed the study. Clinical failure rates were 1.37% (95% confidence intervals [CIs] 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 noninferior compared with each of the reference condoms and had a similar safety profile.
CONCLUSIONS: This ultrathin, natural rubber latex condom of <50 µm has been clinically tested to current International Organization for Standardization standards. The 42 µm condom was as effective as the 55 and 70 µm condoms, demonstrating that performance in terms of failure rate, slippage, or breakage was not altered by its thinness.
IMPLICATIONS: This ultrathin NRL condom of <50 µm has been clinically tested to current International Organization for Standardization standards. This could help to ease concerns about whether ultrathin condoms might compromise reliability and increase failure rate.
STUDY DESIGN: In this blinded, three-way crossover, multicentre study, across four sites in Thailand, couples were randomized to receive one of three thicknesses of condom (42, 55, 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 2 hours of use.
RESULTS: A total of 225 couples completed the study. Clinical failure rates were 1.37% (95% confidence intervals [CIs] 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 noninferior compared with each of the reference condoms and had a similar safety profile.
CONCLUSIONS: This ultrathin, natural rubber latex condom of <50 µm has been clinically tested to current International Organization for Standardization standards. The 42 µm condom was as effective as the 55 and 70 µm condoms, demonstrating that performance in terms of failure rate, slippage, or breakage was not altered by its thinness.
IMPLICATIONS: This ultrathin NRL condom of <50 µm has been clinically tested to current International Organization for Standardization standards. This could help to ease concerns about whether ultrathin condoms might compromise reliability and increase failure rate.