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The role of androgens in the treatment of genitourinary syndrome of menopause (GSM)

International Society for the Study of Women's Sexual Health (ISSWSH) expert consensus panel review

Simon, James A. MD1; Goldstein, Irwin MD2; Kim, Noel N. PhD3; Davis, Susan R. MBBS, PhD4; Kellogg-Spadt, Susan PhD5; Lowenstein, Lior MD6; Pinkerton, JoAnn V. MD7; Stuenkel, Cynthia A. MD8; Traish, Abdulmaged M. PhD9; Archer, David F. MD10; Bachmann, Gloria MD11; Goldstein, Andrew T. MD12; Nappi, Rossella E. MD13; Vignozzi, Linda MD14

doi: 10.1097/GME.0000000000001138
Review Article

Objective: The objective of this consensus document is to broaden the perspective on clinical management of genitourinary syndrome of menopause to include androgens.

Methods: A modified Delphi method was used to reach consensus among the 14 international panelists representing multiple disciplines and societies.

Results: Menopause-related genitourinary symptoms affect over 50% of midlife and older women. These symptoms have a marked impact on sexual functioning, daily activities, emotional well-being, body image, and interpersonal relations. Tissues in the genitourinary system are both androgen and estrogen-dependent. The clitoris, vestibule, including minor and major vestibular glands, urethra, anterior vaginal wall, periurethral tissue, and pelvic floor are androgen-responsive. Historically, treatment of postmenopausal genitourinary symptoms involved both androgens and estrogens. This subsequently gave rise to predominantly estrogen-based therapies. More recently, double-blind, placebo-controlled clinical trials have demonstrated that local vaginal dehydroepiandrosterone improves symptoms in postmenopausal women, including moderate to severe dyspareunia. Limited data suggest that systemic testosterone treatment may improve vaginal epithelial health and blood flow. Open-label studies that have used high doses of intravaginal testosterone in the presence of aromatase inhibitor therapy for breast cancer have resulted in supraphysiological serum testosterone levels, and have been reported to lower vaginal pH, improve the vaginal maturation index, and reduce dyspareunia.

Conclusions: Vaginal dehydroepiandrosterone, hypothesized to enhance local production of both androgen and estrogen, is effective for the management of dyspareunia in menopause. Vaginal testosterone offers potential as a treatment for genitourinary syndrome of menopause, but more studies are needed.

1IntimMedicine Specialists, George Washington University, Washington, DC

2Sexual Medicine, Alvarado Hospital, San Diego, CA

3Institute for Sexual Medicine, San Diego, CA

4Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic, Australia

5Center for Pelvic Medicine, Rosemont, PA

6Department of Obstetrics and Gynecology, Rambam Health Care Campus, Technion School of Medicine, Haifa, Israel

7The North American Menopause Society; Professor of Obstetrics and Gynecology, University of Virginia Health System, Charlottesville, VA

8University of California, San Diego, School of Medicine, La Jolla, CA

9Department of Urology, Boston University School of Medicine, Boston, MA

10CONRAD Clinical Research Center, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA

11Department of Obstetrics, Gynecology and Reproductive Sciences, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ

12Center for Vulvovaginal Disorders; George Washington University, Washington, DC

13Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS S. Matteo Foundation, University of Pavia, Pavia, Italy

14Gynecological Endocrinology Research Unit, Sexual Medicine and Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.

Address correspondence to: James A. Simon, MD, 1850 M Street, NW #450, Washington, DC 20036. E-mail:

Received 1 February, 2018

Revised 20 March, 2018

Accepted 20 March, 2018

Funding/support: This project was supported by an unrestricted grant from AMAG Pharmaceuticals.

Financial disclosure/conflicts of interest: JAS—Advisory Board/Consultant: AbbVie, Inc., Allergan, Plc, AMAG Pharmaceuticals, Inc., Amgen, Ascend Therapeutics, Azure Biotech, Inc., Bayer HealthCare Pharmaceuticals Inc., CEEK Enterprises, LLC, Covance Inc., Millendo Therapeutics, Inc., Mitsubishi Tanabe Pharma Development America, Inc., ObsEva SA, Radius Health, Inc., Sanofi S.A., Sebela Pharmaceuticals, Inc., Sermonix Pharmaceuticals, Inc., Shionogi Inc., Symbiotec Pharmalab, TherapeuticsMD, Valeant Pharmaceuticals. Speaker: Duchesnay USA, Novo Nordisk, Shionogi Inc., Valeant Pharmaceuticals. Grants/Research: AbbVie, Inc., Allergan, Plc, Agile Therapeutics, Bayer Healthcare LLC., Myovant Sciences, New England Research Institute, Inc., ObsEva SA, Palatin Technologies, Symbio Research, Inc., TherapeuticsMD. Stock Shareholder: Sermonix Pharmaceuticals; IG—Advisory Board/Consultant: AMAG Pharmaceuticals, Aytu BioScience, Ipsen, Shionogi, Strategic Science & Technologies, Valeant Pharmaceuticals. Speaker: AMAG Pharmaceuticals, Cynosure, Valeant Pharmaceuticals. Grants/Research: Endoceutics, Palatin Technologies; NNK—Grants/Research: Valeant Pharmaceuticals; SRD—Grants/Research: Lawley Pharmaceuticals. Consultant: Pfizer Pharmaceuticals, Besins Healthcare. Susan R Davis is an Australian NHMRC Senior Principal Research Fellow; SK-S—Advisory Board/Consultant: Materna, Symbiomix, Aytu BioScience, AMAG Pharmaceuticals, Lelo; Speaker: Duchesnay; JP—Grants/Research: Therapeutics MD. Consultant: Pfizer; DFA—Advisory Board/Consultant: Abbvie, Agile Therapeutics, Evestra, Exeltis (formerly CHEMO), Radius Health, TherapeuticsMD. Grants/Research: Abbvie, Bayer Healthcare, Endoceutics, Glenmark, Radius Health, Shionogi, TherapeuticsMD. Stock Options: Agile Therapeutics; GB—Advisory Board/Consultant: AMAG Pharmaceuticals, Inc., Exeltis USA. Grants/Research: Bayer Healthcare Pharmaceuticals. Opinion Leader Roundtable: Endoceutics. Co-author: Uptodate; ATG—Advisory Board/Consultant: AMAG Pharmaceuticals, Ipsen, Strategic Science & Technologies, Emotional Brain; REN—Advisory Board/Consultant: Bayer HealthCare, Endoceutics, Gedeon Richter, HRA Pharma, MSD, Novo Nordisk, Pfizer, Shionogi, Teva. Speaker: Bayer HealthCare, Endoceutics, Gedeon Richter, HRA Pharma, MSD, Novo Nordisk, Pfizer, Shionogi and Teva; LV—Advisory Board: Bayer AG. Speaker: Bayer AG, Bruno FarmaceuticiS.p.a. Grants/Research: Bayer AG, IBSA Farmaceutici, Teva Pharmaceuticals Industries Ltd.

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© 2018 by The North American Menopause Society.