FDA grants first condom approval for anal sex

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To try to amass data that could lead to the approval of condoms for anal sex, the company partnered with researchers at Emory University, met with the FDA, and designed a study.

Funded by the National Institutes of Health, the study, the largest to date on the effectiveness of condoms during anal sex, was conducted between May 2016 and May 2017. It involved 504 men, half of whom had sex with men and the other half had sex with men. women, and the researchers took several steps to encourage more consistent and accurate data than previous studies, Dr. Siegler said.

After being trained in proper condom use, the men were given condoms and asked to fill out a daily diary on a phone app, answer questions about whether they had sex that day- there and if the condom they used had broken or slipped off. Participants reported 2,351 anal sex acts and 2,533 vaginal sex acts during the study period.

Dr Siegler said the team had speculated that the condom failure rate during anal sex would be low enough to pass the FDA test, but did not expect it to be. as low as it was – 0.7% – or it would be lower. than the failure rate during vaginal intercourse, which was 1.9 percent.

The researchers attribute the higher failure rate during vaginal intercourse to the fact that the study encouraged the use of an appropriate lubricant for condoms with each anal intercourse, but, in accordance with public health guidelines, only encouraged the use of lubricant during vaginal intercourse “as needed or desired”.

So while 98% of people who had anal sex used lube, only 42% of those who had vaginal sex did. When researchers only looked at people who used lube, the failure rate in the vaginal group was 1.1%, making the odds of failure in each group essentially the same, according to the study. .

Public health experts said this suggested lube was critical to the study results, and in its statement, the FDA said that during anal sex, the condom “should be used with a lubricant compatible with The preservative”.

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