The primary condom particularly designed to forestall the transmission of HIV and different sexually transmitted infections throughout anal intercourse has been authorized on the market in the USA, the U.S. Meals and Drug Administration says.
The One Male Condom will also be used to assist cut back the chance of being pregnant and sexually transmitted infections (STIs) throughout vaginal intercourse.
When having anal intercourse, the FDA mentioned the condom ought to be used with a condom-compatible lubricant.
“The danger of STI transmission throughout anal intercourse is considerably larger than throughout vaginal intercourse. The FDA’s authorization of a condom that’s particularly indicated, evaluated and labeled for anal intercourse could enhance the probability of condom use throughout anal intercourse,” mentioned Courtney Lias, of the FDA’s Heart for Units and Radiological Well being.
The condom is marketed by International Safety Corp. It was assessed in a medical trial that included 252 males who’ve intercourse with males and 252 males who’ve intercourse with ladies. All had been between the ages of 18 to 54.
The general price of antagonistic occasions was 1.92%. This included symptomatic STIs or latest STI analysis, condom or lubricant-related discomfort, companion discomfort with lubricant and companion urinary tract an infection, all occurring in lower than 1% of members.
The symptomatic STIs or latest STI diagnoses had been self-reported by research members, who weren’t checked for STIs firstly of the research. Meaning sexually transmitted infections could have occurred attributable to having intercourse with out a condom or earlier than members began utilizing the One Male Condom, in response to the FDA.
The condom was authorized by way of the De Novo premarket evaluation pathway for low- to moderate-risk gadgets of a brand new sort.
“This authorization helps us accomplish our precedence to advance well being fairness by way of the event of protected and efficient merchandise that meet the wants of numerous populations,” Lias mentioned in an company information launch.
For extra on sexually transmitted infections amongst homosexual males, see the U.S. Facilities for Illness Management and Prevention.
© 2022 HealthDay. All rights reserved.
FDA approves first condom designed for anal intercourse (2022, February 23)
retrieved 23 February 2022
This doc is topic to copyright. Aside from any honest dealing for the aim of personal research or analysis, no
half could also be reproduced with out the written permission. The content material is offered for data functions solely.