THURSDAY, Nov. 17, 2016 (HealthDay News) -- Intrarosa has been approved by the U.S. Food and Drug Administration to treat women who have moderate-to-severe pain during sexual intercourse caused by post-menopausal vulvar and vaginal atrophy (VVA).
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As the FDA explained, during menopause estrogen levels can decline in vaginal tissues, leading to VVA.
The product, contained in a once-daily insert, is the first approved to include the active ingredient prasterone, also known as dehydroepiandrosterone (DHEA), the agency said Thursday in a news release.
The product's effectiveness was established in two 12-week clinical trials involving 406 post-menopausal women, aged 40 to 80. The most common adverse reactions included vaginal discharge and abnormal Pap smear, a test used to detect cervical cancer.
Intrarosa is marketed by Endoceutics Inc., based in Quebec, Canada.
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