The Food and Drug Administration has authorised the first condom designed specifically for anal sex. The One Male Condom, as it’s being marketed, can be used for vaginal sex as well, but it’s hoped this authorization will improve condom use for anal sex, which carries a higher risk of spreading certain sexually transmitted infections like HIV.
The One Male Condom was tested out in a clinical trial of just over 500 people, with two groups split evenly between men who have sex with men and men who have sex with women. The failure rate of the condom — defined as the condom slipping off or breaking during sex — was found to be 0.68% during anal sex, and 1.92% during vaginal sex. There were no serious adverse events reported, though less than 1% of participants did report an STI or recent STI diagnosis during the trial. Though these infections may reflect the rare risk of condom failure, it’s also possible that some cases preceded the trial or could have occurred in the absence of condom use.
Condoms and similar barrier methods have long been recommended for all forms of sexual intercourse, anal included, to prevent the spread of sexually transmitted infections. And every FDA-cleared condom, including this one, can still be used to prevent STIs and pregnancy from vaginal sex, the FDA notes. But authorizing the One Male Condom, the agency said, may encourage more people to wear a rubber during anal sex when they wouldn’t otherwise — an important goal, given its added infection transmission risks. It’s also possible, the FDA added, that this authorization will pave the way for similar products to get to market faster.
“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,” said Courtney Lias, director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Centre for Devices and Radiological Health, in an FDA statement. “Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations.”
The One Male Condom, made out of natural rubber latex, is being marketed under Global Protection Corp’s One condom brand. It will come in three varieties, standard, thin, and fitted, with the fitted version coming in 54 sizes. When used for anal sex, it should be paired with a condom-safe lubricant. And though this and other condoms may work just fine for any type of intercourse, the CDC still recommends that people use a fresh condom when switching between anal, oral, and vaginal sex.