Condom was approved through the De Novo premarket review pathway for low- to moderate-risk devices of a new type
THURSDAY, Feb. 24, 2022 (HealthDay News) — The first condom specifically designed to prevent the transmission of HIV and other sexually transmitted infections (STIs) during anal sex has been approved for sale in the United States, the U.S. Food and Drug Administration says. The One Male Condom can also be used to help reduce the risk for pregnancy and STIs during vaginal intercourse.
“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” said Courtney Lias, of the FDA Center for Devices and Radiological Health. “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.”
The condom is marketed by Global Protection Corp. It was assessed in a clinical trial that included 252 men who have sex with men and 252 men who have sex with women. All were between the ages of 18 and 54 years. The rate of condom failure (slippage, breakage, or both slippage and breakage) was 0.68 percent during anal intercourse and 1.89 percent during vaginal intercourse.
The overall rate of adverse events was 1.92 percent. This included symptomatic STIs or recent STI diagnosis, condom or lubricant-related discomfort, partner discomfort with lubricant, and partner urinary tract infection — all occurring in less than 1 percent of participants.
The symptomatic STIs or recent STI diagnoses were self-reported by study participants, who were not checked for STIs at the start of the study. That means infections may have occurred due to having intercourse without a condom or before participants started using the One Male Condom, according to the FDA.
The condom was approved through the De Novo premarket review pathway for low- to moderate-risk devices of a new type.
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