KUALA LUMPUR, Feb 24 – The US Food and Drug Administration (FDA) has approved the sale of condoms specifically indicated for use during anal sex.
The condoms, manufactured by Global Protection Corp, will be marketed under the name One Male Condom.
They are also indicated as a contraceptive to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs) during vaginal intercourse.
Prior to this, no approval had been given by the FDA for condoms specifically indicated for anal intercourse.
“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. The FDA’s authorisation of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” said Dr Courtney Lias, director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices.
“Furthermore, this authorisation helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations.”
Global Protection Corp used data from a study by Dr Aaron Siegler at the Rollins School of Public Health, Emory University, as the basis for its request to the FDA to expand the intended use claim of the One Male Condom to include anal sex.
Participants in the study were divided evenly between men who have sex with men and men who have sex with women.
All participants were provided with the three different versions of One Male Condom: fitted, thin and standard.
They were required to note their sexual activity in an electronic daily diary.
The study found that the total condom failure rate was 0.68 per cent for anal intercourse and 1.89 per cent for vaginal intercourse with the One Male Condom.
Condom failure rate was defined as the number of slippage, breakage, or both slippage and breakage events that occurred over the total number of sex acts performed.
“There have been over 300 condoms approved for use with vaginal sex data, and never before has a condom been approved based on anal sex data,” said Dr Siegler.
“This is despite two-thirds of HIV transmission in the United States being linked to anal sex. Having condoms tested and approved for anal sex will allow users to have confidence in using condoms to prevent HIV transmission.”
