The first condoms specifically indicated for use during anal sex gained a thumbs up from the FDA, the agency announced on Wednesday.
One Male Condoms, manufactured by Global Protection of Boston, received marketing authorization to prevent sexually transmitted infections (STIs) during anal intercourse, including HIV. The move could improve public health efforts to reduce STIs, the agency said.
“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” Courtney Lias, PhD, of FDA’s Center for Devices and Radiological Health, 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,” Lias added. “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.”
One Male Condom is also indicated to prevent pregnancy and the transmission of STIs during vaginal intercourse, the agency stated.
Public health authorities have long recommended condom use during both vaginal and anal intercourse. But prior to today’s authorization, there was not enough data showing that condoms were safe and effective for use during anal sex.
The FDA’s decision is based on a clinical trial measuring the safety and efficacy of One Male Condoms in more than 500 patients (ages 18-54) — 252 men who had sex with men and 252 men who had sex with women. The investigators measured condom failure rate, which was defined as the number of breakage or slippage events that occurred over a total number of sexual encounters.
The condom failure rate was 0.68% for anal intercourse and 1.89% for vaginal intercourse. Additionally, the overall adverse event (AE) rate with the One Male Condom was 1.92%, the trial found. AEs included symptomatic STI or a recent STI diagnosis (0.64%), condom or lubricant-related discomfort (0.85%), partner discomfort with lubricant (0.21%), and partner urinary tract infection (0.21%).
The latex condoms are available in three different versions: standard, thin, and fitted, the latter of which are available in 54 different sizes. During anal intercourse, One Male Condoms should be used with a condom-compatible lubricant, the agency said.
One Male Condoms were reviewed via the FDA de novo premarket review pathway for low-to-moderate-risk devices of a new type. Companies who manufacture similar products that show a “substantial equivalence” to One Male Condoms can apply for clearance through this pathway, which may enable products to get to the market faster, the agency said.
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