The US FDA has just given permission to market the first condom designed to reduce the transmission of sexually transmitted diseases (STDs) during anal intercourse. Condoms, which will be labeled One Male Condom, are also indicated as contraceptives, to reduce the risk of pregnancy and transmission of sexually transmitted diseases during vaginal intercourse.
Prior to this approval, the FDA had never authorized a product for this specific use although unprotected anal intercourse has the highest risk of HIV transmission. Widespread and correct use of this condom, on the other hand, has the potential to effectively decrease the risk of STD. The authorization of the American government body underlines the public health importance of condoms designed, tested and labeled specifically for anal intercourse, underlining how important it is to continue to use condoms to reduce the risk of STD, including HIV , and to prevent unwanted pregnancies.
The risk of transmission
“The risk of transmission of STD during anal intercourse is significantly greater than during vaginal intercourse, for this reason the FDA authorization for a condom with specific indication, evaluation and labeling can increase the likelihood of its use during anal intercourse”, he precised Courtney Lias, director of the Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health of the FDA. Who also stressed that “this authorization helps us to achieve the goal of developing safe and effective products that meet the health needs of different populations. And this authorization will allow other products of the same type to reach the market more quickly. “.
The results of the study
The newly authorized condom is a latex sheath that covers the penis. It has three different versions, 54 sizes and should be used with a specific lubricant. Its safety and efficacy was studied in a sample aged 18 to 54: 252 men who had sex with men and 252 who had sex with women. The results of the study: the condom failure rate for anal intercourse stopped at 0.68%, while the one in vaginal intercourse was higher at 1.89%. By failure, the study meant the number of breakups, slips, or both in a total of sexual intercourse. The total of adverse effects stopped at 1.92%. Adverse events, on the other hand, include the diagnosis of symptomatic or recent STDs (0.64%), discomfort related to the condom or the lubricant used (0.85%), urinary tract infections of the partner (0.21%).
The symptomatic and non-symptomatic sexually transmitted diseases observed in the study were reported spontaneously by the sample of participants and could also be due to unprotected intercourse by condoms or prior to the use of the One Male Condom, and this is because a measurement was not used. departure of the study.