First such condom approved by the FDA

The US Food and Drug Administration (FDA) has approved the approval of the first condom in the US designed specifically to prevent sexually transmitted infections during anal intercourse. However, condoms, which will be sold under the name One Male, are universal - heterosexual couples can also use them successfully, both as a contraceptive and to prevent disease transmission during vaginal intercourse.

The FDA reminds that unprotected anal intercourse carries the greatest risk of exposure to HIV transmission. The FDA's decision underscores the importance of condoms tested and specifically labeled as appropriate for anal intercourse. Consistent and correct use of them can significantly reduce the risk of sexually transmitted diseases.

- The approval of One Male condoms will help us achieve our priority goal of increasing equity in health by developing safe and effective products that meet the needs of different populations. The presence of such condoms on the market may increase the likelihood of using protection during anal intercourse , said Dr. Courtney Lias of the FDA's Center for Devices and Radiological Health.

The safety and effectiveness of the One Male condom was tested in a clinical trial involving 252 men who had sex with men and 252 men who had sex with women. The participants were between 18 and 54 years old.

The study found that condom problems only occurred in 0.68% of anal intercourse and 1.89% of vaginal intercourse. The problems were that the condom had slipped or broken. The overall rate of adverse events was 1.92%.

Medical adverse events reported during the clinical trial included symptomatic or newly diagnosed STD (0.64%), condom or lubricant discomfort (0.85%), lubricant-related partner discomfort (0.21% ) and infection of the partner's urinary tract (0.21%). As noted by the FDA, the diagnosis of an STI was reported by patients themselves and may be due to sexual intercourse without a condom prior to study initiation (participants were not tested for contamination at the start of the study).

The One Male condom comes in three different versions: standard, thin and fitted. The latter is available in 54 different sizes. The manufacturer also provided a set of paper "templates" to help the user choose the optimal size. When used during anal intercourse, the condom should be used with a "compatible" lubricant.