Intrarosa Postmenopausal

November 18, 2016 –  Do we really need another steroid hormone to treat women? If yes, does it have to be DHEA? The American Food & Drug Administration (FDA) thinks so.  FDA just approved  Prasterone (Intrarosa) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. imageIntrarosa 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 FDA’s Center for Drug Evaluation and Research (CDER). “Prasterone (Intrarosa) provides an additional treatment option for women seeking relief of dyspareunia caused by VVA.”

Efficacy of Prasterone (Intrarosa), a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 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 Prasterone (Intrarosa) or a placebo vaginal insert. Prasterone (Intrarosa), when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse.

The safety of Prasterone (Intrarosa) was established in four 12-week placebo-controlled trials and one 52-week open-label 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. Overall, DHEA may not be as begnin as it may appear here. If we consult MedlinePlus for safety information on supplements (i.e, DHEA in this case), it becomes clear that there exists quite an array of adverse effects to go with the use of DHEA. Patients using Prasterone (Intrarosa) might be well advised to be careful. The brand name Intrarose might be misleading.

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thassodotcom

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Posted in New Drug Approval, Thasso Post, Theragenomic Medicine, Uncategorized
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