FDA OKs first condom specifically indicated to prevent STIs during anal sex

The FDA has authorized the marketing of One Male Condom, which the agency said is the first condom specifically indicated to help reduce the transmission of sexually transmitted infections during anal sex.

One Male Condom (Global Protection Corp.) is also indicated to lower the risk for pregnancy and sexually transmitted infections (STIs) during vaginal sex, the FDA said.

Last year, the CDC announced a record number of STIs in the U.S. in 2019, with more than 2.5 million cases of chlamydia, gonorrhea and syphilis. In addition, recent worldwide data from WHO revealed a high prevalence of anal HPV among men who have sex with men, regardless of HIV status.

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” Courtney Lias, PhD, the director of the Office of GastroRenal, ObGyn, General Hospital and Urology Devices in the Center for Devices and Radiological Health at the FDA, said in a press release. “The FDA’s authorization of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse.”

One Male Condom is a natural rubber latex sheath that comes in standard, thin and fitted types. There are 54 different sizes and a paper template to help ensure the “best condom size for each user,” according to the press release. During anal sex, the condom should be used with a condom-compatible lubricant, the FDA said.

The authorization was based on a trial including 252 men who had sex with men and 252 men who had sex with women, whereby the rate of condom failure — the “number of slippage, breakage or both slippage and breakage events that occurred over the total number of sex acts performed” — was 0.68% for anal sex and 1.89% for vaginal sex, according to the release.

The FDA said adverse events reported during the clinical trial included STI symptoms or a recent STI diagnosis, condom- or lubricant-related pain, partner pain with lubricant and partner UTI. Fewer than 2% of all study participants experienced these events. The agency also said that since STIs were not measured at baseline, it is possible the STI symptoms and diagnoses may have occurred from sex without a condom or before use of the One Male Condom.

“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,” Lias said.