The United States Food and Drug Administration today approved the sale of the first condoms designed to help prevent sexually transmitted infections (STIs) during anal intercourse. The condoms, known as the One Male Condom, are also intended to be used as a contraceptive to help minimize the chance of pregnancy and STI transmission during vaginal intercourse.
The FDA had not authorized or recommended condoms expressly for anal intercourse prior to today’s approval. HIV transmission is most likely to occur during unprotected anal intercourse.
Condom use that is consistent and proper has the ability to reduce STI risk dramatically. While today’s approval highlights the importance of condoms that have been studied and labeled especially for anal intercourse in terms of public health, all other FDA-approved condoms can still be used for contraception and STI prevention.
To reduce the risk of STI transmission, including HIV, and to avoid pregnancy, it’s critical to continue to use condoms consistently and correctly.
The One Male Condom is a penis-covering natural rubber latex sheath. It is available in three different styles: normal, thin, and fitted. The fitted condoms come in 54 different sizes and include a paper template to help users discover the right condom size for them. The One Male Condom should be used with a condom-compatible lubricant during anal intercourse.
A clinical investigation including 252 men who have sex with men and 252 men who have sex with women was conducted to determine the safety and efficacy of the One Male Condom. All of the participants were between the ages of 18 and 54.
The study discovered that the total condom failure rate for anal intercourse was 0.68 percent and for vaginal intercourse was 1.89 percent when using the One Male Condom. The failure rate of condoms was defined as the number of slippage, breakage, or combined slippage and breakage events per total number of sexual actions conducted.
The overall rate of adverse events was 1.92 percent for the One Male Condom. Symptomatic STI or recent STI diagnosis (0.64 percent), condom or lubricant-related discomfort (0.85 percent), partner lubricant discomfort (0.21 percent), and partner urinary tract infection (0.21 percent) were all reported as adverse outcomes during the clinical study (0.21 percent ).
The symptomatic STIs or recent STI diagnoses found in the trial were self-reported and could have occurred as a result of respondents engaging in sexual activity without using a condom or could have occurred prior to the use of the One Male Condom, as STIs were not tested at baseline.
Source: FDA
