On Wednesday February 23, the American Medicines Agency authorized the marketing of the first condoms specifically indicated to protect against the risk of sexually transmitted infection during anal intercourse.
- The study on this condom was carried out between May 2016 and May 2017.
- The failure rate had to be less than 5% for the condom to be authorized.
The use of a condom is recommended when having sex with people you don’t know very well. And for the first time, the American health authorities officially authorize a brand to market condoms dedicated to anal sex. The decision was announced in a communicated from the Food and Drug Administration (FDA), Wednesday, February 23.
encourage condom use
“Prior to today, the FDA had not cleared or approved condoms specifically indicated for anal intercourse.”, explains the organization. However, the risk of transmission of a sexually transmitted infection (STI) during anal intercourse is significantly higher than during vaginal intercourse. “FDA clearance of condom specifically indicated, rated, and labeled for anal intercourse may improve likelihood of condom use during anal intercourse“, estimates Courtney Lias, director of the office in particular dedicated to urology within the FDA.
Before conducting their pre-licensing clinical trial, the authors conducted a survey of more than 10,000 men who have sex with men. 69% of them said that if the FDA allowed a condom specifically for anal sex, they would feel more incentive to use them. If for the time being, only one brand is authorized, the FDA indicates that classification elements have been developed and will allow other condoms to obtain the same authorization in the future.
Authorization based on a scientific study
The One Male Condom, name of this condom dedicated to anal sex, is made of natural rubber. It was tested in a clinical trial with 504 men: half of them had sex with men and the other half with women. After each use of the condom, they were asked to answer questions on a mobile application. For example, men were asked if the condom slipped off or broke during intercourse.
The results of the study show that the total condom failure rate was 0.68% for anal intercourse and 1.89% for vaginal intercourse. This condom failure rate was defined as the number of cases that slipped, broke, or both. At the same time, the scientists identified the number of adverse events: an STI, condom-related discomfort or a urinary tract infection. In total, these events were recorded in 1.92% of cases.
Why do the results differ depending on the type of sex practiced?
In an article from New York Times, Aaron Siegler, an epidemiologist at Emory University who helped lead the study, says the team didn’t expect such a low failure rate for anal intercourse compared to vaginal intercourse. Scientists explain this difference by the use of lubricant, which was recommended for anal intercourse and suggested for vaginal intercourse. 98% of people who had anal sex used lube, compared to only 42% of those who had vaginal sex. Thus, the authors believe that the use of a lubricant, compatible with the condom, should be encouraged.
Today, we authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. https://t.co/zmAWtFty58 pic.twitter.com/0SwlWkSh4S
— US FDA (@US_FDA) February 23, 2022