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First Condom Approved for Anal Sex by FDA

Emell Adolphus READ TIME: 2 MIN.

At long last, the U.S. Food and Drug Administration is giving the go ahead for a condom to be used for anal sex.

In a statement released on Wednesday, the government agency authorized the marketing of the "One Male Condom,"the first condoms to approved by the FDA to specifically help reduce transmission of sexually transmitted infections (STIs) and HIV transmission during anal intercourse.

The condoms are also can be used as a contraceptive to help reduce the risk of pregnancy and the transmission of STIs during vaginal intercourse.

"The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. 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," said Courtney Lias, Ph.D., director of the FDA's Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.

Furthermore, Lias shared that the authorization will help the FDA "accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations."

Although condoms have been used as protection during anal sex for a long time, the FDA had not officially approved any condom for anal intercourse because it reportedly had a lack of data from regulators for approval.

The safety and efficacy of The One Male Condom's efficacy was study in a clinical trial featuring "252 men who have sex with men and 252 men who have sex with women. All participants were between 18 through 54 years old," according to the FDA.

Manufactured by Global Protection Corp, the ONE condom is made of a natural rubber latex sheath for the penis and comes in standard, thin and fitted sizes.

Will you be looking for the ONE Male condom in stores?

Read the full statement from the FDA to learn more about the ONE Male Condom's clinical trials.


by Emell Adolphus

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