The Food and Drug Administration (FDA) has authorized marketing of the One Male Condom as the first condom indicated to help reduce the transmission of sexually transmitted infections (STIs) during anal intercourse. It is also indicated as a contraceptive to help reduce the risk of pregnancy and the transmission of STIs during vaginal intercourse.

The FDA authorization was based on efficacy and safety data from a clinical trial led by Dr Aaron Siegler at the Rollins School of Public Health at Emory University. The study included 252 men who have sex with men and 252 men who have sex with women. All participants (between 18 to 54 years of age) used the One Male Condom and tracked their sexual activity in an electronic daily diary.

Findings showed that the total condom failure rate, defined as the number of slippage, breakage or both slippage and breakage events that occurred over the total number of sex acts performed, was 0.68% for anal intercourse and 1.89% for vaginal intercourse.

“A critical finding of the study was that failure was low when condom-compatible lubricant was used, and the use of lubricant is part of the new FDA label indication. Programs providing condoms should also be providing lubricant,” said Dr Siegler.

Adverse events reported in the 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 were self-reported by participants, and may be due to intercourse without a condom or may have occurred prior to use of the One Male Condom; STIs were not measured at baseline. 

“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, PhD, 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.”

While the One Male Condom was specifically tested and labeled for anal intercourse, the Agency noted that all other FDA-cleared condoms can continue to be used for contraception and STI prevention.

References

  1. US Food and Drug Administration. FDA permits marketing of first condom specifically indicated for anal intercourse. News release. Accessed February 23, 2022. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse.
  2. In landmark shift, ONE® brand condoms are first to receive FDA approval for “safe and effective use” label for anal sex. News release. Accessed February 23, 2022. https://www.prnewswire.com/news-releases/in-landmark-shift-one-brand-condoms-are-first-to-receive-fda-approval-for-safe-and-effective-use-label–for-anal-sex-301489090.html.