WASHINGTON (1010 WINS) -- The U.S. Food and Drug Administration made history Wednesday: it authorized the marketing of the first condoms "specifically indicated to help reduce transmission of sexually transmitted infections during anal intercourse," the federal agency announced.
The condoms, which will be marketed as the One Male Condom, are also indicated as a contraceptive to help reduce the risk of pregnancy and the transmission of STIs during vaginal intercourse, as well.
Before Tuesday's authorization, the FDA had not cleared or approved condoms specifically indicated for anal intercourse.
According to the FDA, "The One Male Condom is a natural rubber latex sheath that covers the penis. 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. When used during anal intercourse, the One Male Condom should be used with a condom-compatible lubricant."
"The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse," said Courtney Lias, Ph.D., director of the FDA's Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the 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."
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. This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster."
The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women. All participants were 18-54 years of age.
The study found that the total condom failure rate was 0.68% for anal intercourse and 1.89% for vaginal intercourse with the One Male Condom, according to the FDA. Condom failure rate was defined as the number of slippage, breakage or both slippage and breakage events that occurred over the total number of sex acts performed.
