The US Food and Drug Administration (FDA) authorized the sale of the first condoms specific for anal sex on February 23, in order to reduce the risk of sexually transmitted diseases ( STD).
Although conventional prophylactics were already widely used for this practice, the FDA had not yet officially authorized any brand for that specific use, due to lack of data. They were only approved for vaginal sex.
“The risk of sexually transmitted infections during anal intercourse is significantly higher than during vaginal intercourse. “FDA clearance of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” said FDA official Dr. Courtney Lias.
“In addition, this authorization helps us achieve our priority of promoting health equity through the development of safe and effective products that meet the needs of diverse populations,” he added.
The condom, produced by the company Global Protection Corp, will be marketed under the name One Male Condom. However, it is no different from others and is identical to the “One” condoms, which the company already sold. The best result is due to the use of an adapted lubricant, which reduces friction. It will be available in three versions: standard, slim or slim, with 54 sizes available.
Studies
The safety and effectiveness of One Male Condom was studied in a clinical trial consisting of 252 men who have sex with men and 252 men who have sex with women. All participants were between 18 and 54 years old.
The study found that the overall condom failure rate was 0.68% for anal sex and 1.89% for vaginal sex with One Male Condom. Condom failure rate was defined as the number of slipping, breaking, or slipping and breaking events that occurred over the total number of sexual acts performed. For One Male Condom, the overall adverse event rate was 1.92%.
Adverse events reported during the clinical trial included symptomatic STIs or newly diagnosed STIs (0.64%), discomfort related to the condom or lubricant (0.85%), partner discomfort with the lubricant (0.21% ) and urinary tract infection in the partner (0.21%).
Symptomatic STIs or recent STI diagnoses observed in the study were self-reported and may be a result of subjects having condomless sex or may have preceded use of One Male Condom, as STIs were not measured at baseline of the study.
