For Immediate Release:

Spanish

Today, the US Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. 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.

Before today’s authorization, the FDA had not cleared or approved condoms specifically indicated for anal intercourse. Unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission. Consistent and correct condom use has the potential to significantly help decrease the risk of STIs. While today’s authorization underscores the public health importance of condoms tested and labeled specifically for anal intercourse, all other FDA-cleared condoms can continue to be used for contraception and STI prevention. It’s important to continue to use condoms consistently and correctly to reduce the risk of STI transmission, including HIV, and to prevent pregnancy.

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. 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,” 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. “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 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 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 between 18 through 54 years old.

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. 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. For the One Male Condom, the overall percentage of adverse events was 1.92%. Adverse events reported during the clinical trial included symptomatic STI or 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 symptomatic STI or recent STI diagnoses observed in the study were self-reported and may be the result of subjects having intercourse without a condom or may have preceded use of the One Male Condom, as STIs were not measured at baseline.

The FDA reviewed the One Male Condom through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The FDA granted the marketing authorization to Global Protection Corp.

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The FDA, an agency within the US Department of Health and Human Services, protects the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.