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FDA Approves Intrarosa for Sexual Pain in Postmenopausal Women

Feb 21, 2017

FDA Approves Intrarosa for Sexual Pain in Postmenopausal Women

Postmenopausal women who experience moderate to severe pain during intercourse may have a new treatment option.

Last November, the U.S. Food and Drug Administration (FDA) approved a drug called Intrarosa (prasterone) for sexual pain caused by vulvar and vaginal atrophy (VVA) due to menopause.

When a woman goes through menopause, her body starts producing less estrogen, a hormone that keeps the vagina and vulva healthy. In particular, estrogen helps keep the vagina flexible and lubricated during sex.

For many women, declining estrogen levels bring about cellular changes to the vagina and vulva, leaving them dry and brittle. With poorer lubrication and less elasticity in the vagina, intercourse can become uncomfortable or painful.

The active ingredient in Intrarosa is the hormone dehydroepiandrosterone (DHEA), which changes to estrogen. The drug is administered as a daily vaginal insert. In general, women are advised to place one insert into the vagina each night at bedtime, using a special applicator.  

The effectiveness of Intrarosa was tested in two 12-week clinical trials of 406 postmenopausal women between the ages of 40 and 80 who had moderate to severe pain during intercourse. The women were randomly assigned to try Intrarosa or a placebo insert. Those who used Intrarosa reported less severe sexual pain.

The most common side effects were vaginal discharge and an abnormal Pap smear.

Women who have vaginal bleeding should talk to their doctor before using Intrarosa. In addition, women who have a history of breast cancer should not use Intrarosa at all.

The FDA warns that while Intrarosa contains DHEA and has been approved to treat sexual pain in postmenopausal women, other products containing DHEA, such as dietary supplements, have not.

“The efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating, or preventing of any disease,” the agency said in a press statement.

Resources

Mayo Clinic

“DHEA – Background”

(Last updated: July 1, 2014)

http://www.mayoclinic.org/drugs-supplements/dhea/background/hrb-20059173

MedPage Today

Walker, Molly

“FDA Approves Intrarosa for Sexual Symptoms of Menopause”

(November 17, 2016)

http://www.medpagetoday.com/obgyn/menopause/61522

SexHealthMatters.org

“Vulvar and Vaginal Atrophy”

(June 26, 2013)

http://www.sexhealthmatters.org/sex-health-blog/vulvar-and-vaginal-atrophy

U.S. Food and Drug Administration

“FDA approves Intrarosa for postmenopausal women experiencing pain during sex”

(News Release. November 17, 2016)

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm529641.htm

"Full Prescribing Information”

(Revised: November 2016)

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208470s000lbl.pdf