The male condom “One Male Condom” has just obtained approval from the Food and Drug Administration (FDA) to be marketed. It is a product specially designed for anal intercourse, capable of protecting against sexually transmitted infections (STIs).
Before this decision, the “One Male Condom” had been the subject of a study involving several hundred people, which served to test its effectiveness. The results showed that its failure rate was only 0.68%.
This is the first time the FDA has approved a condom for use in anal sex. The organization now encourages other condom manufacturers to submit their products for similar approval. However, they must have the same efficiency rate.
Limit the transmission of STIs
As experts know, the risk of STI transmission is higher for anal intercourse than for vaginal intercourse. So, for quite some time, sexual health specialists have been waiting for the approval of a product suitable for anal sex so that those affected can have a safer sexual experience.
The authorization issued by the FDA thus corresponds to an important step for the organization. This enables it to advance health equity through the development of safe and effective products.
“FDA clearance of a condom specifically indicated, rated, and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse”declared the doctor Courtney Lias, director within the agency.
The clinical trial
To test the effectiveness of the new condom, a clinical trial was conducted with 252 men who have sex with men and 252 men who have sex with women. The experiment revealed a failure rate of 0.68% for anal intercourse and 1.89% for vaginal intercourse. Failures usually result in the condom slipping and/or breaking.
Aside from approving the first male condom for anal intercourse, the FDA also implemented a new regulatory classification to allow other companies to quickly obtain similar clearance, should they wish.
Apart from the standard and thin versions, the “One Male Condom” will also be available in 54 different sizes. Users will be able to choose the one that suits them by referring to a paper template. It should be noted that this new condom must be used with a lubricant.