FDA Authorizes the First Condom for Anal Sex

Source: Freepik

FDA grants approval to a condom specifically designed for preventing sexually transmitted infections during anal sex.

Unprotected anal intercourse carries a much higher risk of sexually transmitted infections (STIs) than vaginal sex. However, in recent years, the use of condoms during anal sex has significantly declined. Thus, putting people at a greater risk of HIV and other infections. The One Male Condom, therefore, aims to encourage safe sex practices among people who engage in anal sex. Now, for the first time, the U.S. Food and Drug Administration (FDA) has authorized the marketing of the specific condom.

The FDA’s authorization of a condom that is specifically indicated, evaluated and labelled for anal intercourse may improve the likelihood of condom use during anal intercourse.

Dr. Courtney Lias, FDA

One Male Condom

According to the press release, the approval was based on the results of the largest trial to assess the effectiveness of condoms for anal sex. The study recruited 252 men who have sex with men and 252 men who have sex with women. As part of the trial, participants received proper training in proper condom use. The condom has three different versions: standard, thin, and fitted; the fitted version comes in 54 different sizes. Researchers gave participants five samples of each version to use for 2-4 weeks.

They were then instructed to fill out a daily sex diary on a phone app. The participants further answered questions on whether the condom broke or slipped while in use. Results revealed a lower failure rate (0.7%) during anal sex than vaginal intercourse (1.9%). However, there was no difference in failure rate among the three condom types. Moreover, the use of a lubricant lowered the failure rate for both anal and vaginal sex. Therefore, health officials recommend the use of lubricants along with the condoms.

The study further looked at reports of symptomatic STIs or recent STI diagnoses during the trial. Although the STIs were reported in less than 1% of condom use, researchers attributed them to possibly occurring due to participants not using a condom. Or they could have preceded the use of the One Male Condom. 

Health officials hope that the approval of the condom will increase people’s access and awareness to various prevention options.


Siegler AJ, Rosenthal EM, Sullivan PS, et al. Levels of clinical condom failure for anal sex: A randomized cross-over trial. EClinicalMedicine. 2019;17:100199. Published 2019 Oct 31. doi:10.1016/j.eclinm.2019.10.012


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