To try to collect data that could lead to the approval of condoms for anal sex, the company teamed up with researchers at Emory University, met with the FDA, and designed a study.
The National Institutes of Health-funded 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 half had sex. had with women, and the researchers took several steps to encourage more consistent and accurate data than previous studies, said Dr. siegler.
After being trained in proper condom use, the men were given condoms and asked to fill in a daily diary on a phone app, to answer questions about whether they had had sex that day and whether the condom they were using broke or slipped. . The participants reported 2,351 anal and 2,533 vaginal sex acts during the study period.
dr. Siegler said the team had assumed the condom failure rate during anal sex would be low enough to pass the FDA, but hadn’t expected it to be as low as it was — 0.7 percent — or lower. than the failure rate during vaginal sex, which was 1.9 percent.
The researchers attributed the higher failure rate during vaginal sex to the fact that the study encouraged lubricant compatible with condoms to be used for any case of anal sex, but, following public health guidelines, only encouraged lubricant to to be used during vaginal sex “as needed or desired.”
So while 98 percent of people who had anal sex used lubricant, only 42 percent of those who had vaginal sex did. When the researchers looked only at people who used lubricant, the failure rate in the vaginal group was 1.1 percent, making the odds of failure essentially the same in each group, the study reported.
Public health experts said this suggests that lubricant was crucial to the results of the study, and in its statement, the FDA said that during anal sex, the condom “should be used with a condom-compatible lubricant.”
