The U.S. Food and Drug Administration on Wednesday announced its first-ever authorization of a condom specifically meant for anal sex.
According to the FDA, the One Male Condom will be manufactured by the American condom manufacturer Global Protection Corp.
The condom maker, whose team is “fiercely passionate about our mission to make condoms as socially acceptable as toothpaste,” is the Boston-based company behind popular condom brands such as Trustex and One.
“The One Male Condom is a natural rubber latex sheath that covers the penis,” the FDA said in a news release. “It has three different versions: standard, thin and fitted. The fitted condoms, available in 54 different sizes, incorporate a paper template to aid in finding the best condom size for each user.”
The agency recommends the use of a condom-compatible lubricant whenever the One Male Condom is being used during anal intercourse.
Regulators say that the targeted marketing could help reduce transmission of sexually transmitted infections, or STIs, during anal intercourse, though the condoms are also indicated as a contraceptive to help reduce the risk of pregnancy and the transmission of STIs during vaginal intercourse.
“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” the FDA’s Courtney Lias said in a statement.
“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,” added Lias, director of the FDA office that handled the approval.
Even though condoms have been used by gay men for that purpose for decades, the FDA didn’t have enough data to allow a condom to be specifically marketed for that use.
The authorization comes after a clinical trial involving 504 men between the ages of 18 and 54. The study found that the total condom failure rate — defined as slippage, breakage or both — was less than 1% during anal intercourse.
According to the FDA, the authorization will help the agency “advance health equity through the development of safe and effective products that meet the needs of diverse populations.”
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