The first condom specifically designed for anal sex has been approved by the United States Food
and Drug Administration.
The FDA had blocked corporations from marketing their products as an effective tool for safe anal sex.
Global Protection Corp.’s One Male Condom would be allowed to be marketed as a product that helps “reduce transmission of sexually transmitted infections” during both vaginal and anal intercourse.
Courtney Lias, Ph.D., director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices said the risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” said
“The FDA’s authorization of a condom that is specifically indicated, evaluated, and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse.
Just last year, Global Protection Corp. requested that the FDA approve the use of the condom for anal sex as part of an update to its labeling.
The company filed the request after a study found that the One Male Condom failed for vaginal sex at 1.89 percent and for anal sex at less than 1 percent.
The clinical trial included more than 500 men, ages 18-54; 252 of them had sex with other men, and 252 had sex with women.
The FDA says the move will allow other companies to apply for similar approval.
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