First condom authorized in the United States for anal sex

the One Male Condom is the first condom officially authorized by the Food and Drug Administration in the United States for anal sex, in addition to its already possible use for vaginal sex. This is the first time that such a condom has been officially approved with this indication by American health authorities.

A clinical trial of more than 500 people

Before obtaining this approval from the FDA, the condom went through the clinical trial stage, conducted between May 2016 and May 2017 on more than 500 people divided into two equal groups. These two groups contained men who have sex with men and men who have sex with women. The participants had to report daily, on a telephone application which contained a questionnaire, if they had had sexual intercourse that day, its nature and their use of the condom, after having been previously trained in its use.

The condom failure rate (which slipped or cracked during intercourse) was 0.68% during anal intercourse and 1.92% during vaginal intercourse. Furthermore, less than 1% of the volunteers reported having had a sexually transmitted infection during the study. A figure which, according to one of the authors of the study, could be explained by reports during which the condom had not been used.

An incentive to protect oneself

By authorizing the One Male Condom, the American health authorities wish to encourage the use of condoms during anal intercourse. Indeed, the risk of sexually transmitted diseases is “significantly higher” during anal sex than during vaginal sex, an FDA official said. But until now, there hasn’t been enough data to show that condoms are safe and effective during anal sex.

The One male condom, made from natural rubber latex, is marketed in the United States under the One condom brand of Global Protection Corp. It will come in three varieties: standard, slim and fitted, with a fitted version available in 54 sizes. “When used for anal sex, it should be paired with a condom-safe lubricant” recommend the authors of the study.

Other similar condoms in the future?

“FDA clearance of a condom specifically indicated, rated, and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse.” said Courtney Lias, one of the directors of the FDA office. It is also possible that this authorization paves the way for a faster commercialization of similar products.

Finally, health professionals are also counting on companies to communicate more about this novelty, which concerns both heterosexuals and homosexuals. “This clearance helps us achieve our priority of advancing health equity through the development of safe and effective products that meet the needs of diverse populations.” concludes Courtney Lias.