"The U.S. Food and Drug Administration approved Intrarosa prasterone to treat women experiencing moderate to severe pain during sexual intercourse dyspareunia a symptom of vulvar and vaginal atrophy VVA due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone which is also known as dehydroepiandrosterone DHEA. During menopause levels of estrogen decline in vaginal tissues which may cause a condition known as VVA leading to symptoms such as pain during sexual intercourse. Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women said Audrey Gassman M.D. deputy director of the Division of Bone Reproductive and Urologic Products DBRUP in the Office of Drug Evaluation III in the FDAs Center for Drug Evaluation and Research CDER. Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA. Efficacy of Intrarosa a oncedaily vaginal insert was established in two week placebocontrolled clinical trials of  healthy postmenopausal women  to  years of age who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa when compared to placebo was shown to reduce the severity of pain experienced during sexual intercourse. The safety of Intrarosa was established in four week placebocontrolled trials and one week openlabel trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear. Although DHEA is included in some dietary supplements the efficacy and safety of those products have not been established for diagnosing curing mitigating treating or preventing any disease. Intrarosa is marketed by Quebecbased Endoceutics Inc. The FDA an agency within the U.S. Department of Health and Human Services protects the public health by assuring the safety effectiveness and security of human and veterinary drugs vaccines and other biological products for human use and medical devices. The agency also is responsible for the safety and security of our nations food supply cosmetics dietary supplements products that give off electronic radiation and for regulating tobacco products."