An overview of dehydroepiandrosterone (EM-760) as a treatment option for genitourinary syndrome of menopause

ABSTRACT

Introduction: Dyspareunia caused by vulvovaginal atrophy is a primary symptom of genitourinary syndrome of menopause (GSM), a chronic, progressive medical condition that results from estrogen and androgen deficiency at menopause. Dehydroepiandrosterone (DHEA, prasterone) is an endogenous precursor steroid hormone that is metabolized into both androgens and estrogens that has been recently been approved by the FDA for the treatment of moderate to severe dyspareunia caused by vulvovaginal atrophy secondary to menopause.

Areas covered: This is a comprehensive drug evaluation describing the chemical composition, pharmacokinetics, metabolism, clinical efficacy and safety of dehydroepiandrosterone (prasterone) in the treatment of dyspareunia and VVA secondary to menopause. Preclinical and clinical data suggesting further potential uses, benefits, and contraindications in the genitourinary health of postmenopausal women are also considered.

Expert opinion: Intravaginal dehydroepiandrosterone (prasterone) is effective for the management of dyspareunia secondary to menopause and may be effective in the treatment of other types of sexual dysfunction that are secondary to menopause. Further studies should explore additional dosing regimens and different indications.

KEYWORDS:

• Dehydroepiandrosterone (DHEA)
• Female androgen insufficiency
• Female sexual dysfunctions (FSDs)
• Genitourinary syndrome of menopause (GSM)
• Prasterone
• Vulvovaginal atrophy

Article highlights

• Dyspareunia caused by vulvovaginal atrophy is a primary symptom of menopause. Intravaginal DHEA (prasterone) is effective for the management of dyspareunia secondary to menopause

• Intrarosa, an FDA approved treatment available to treat GSM, is an intravaginal steroid precursor DHEA (prasterone) that is converted to both androgens and estrogens in the vaginal mucosa.

• Exogenous prasterone is metabolized in the same manner as endogenous DHEA

• There is current evidence suggesting that intravaginal DHEA (prasterone) is effective in treating additional symptoms in women with GSM, such as decreased lubrication, decreased sexual desire, decreased sexual satisfaction, decreased ability to achieve orgasm, and pain.

Declaration of interest

AT Goldstein has served as a consultant for Ipsen, the SST Corporation, Amag and Grunenthal. He has also received research funding from Ipsen, SST, Grunenthal, Elen and Endoceutics. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

One referee declares past financial relationships (as a lecturer, member of advisory boards and/or consultant) with Boehringer Ingelheim, Ely Lilly, Endoceutics, Gedeon Richter, HRA Pharma, Pfizer Inc, Procter & Gamble Co, TEVA Women’s Health Inc, Zambon SpA. Furthermore, they disclose that, at present, they have an on-going relationship with Bayer HealthCare AG, Exceltis, Fidia, Merck Sharpe & Dohme, Novo Nordisk, Palatin Technologies, Shionogi Limited and Theramex. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

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Funding

This manuscript has not been funded.