TY - JOUR
T1 - The role of androgens in the treatment of genitourinary syndrome of menopause (GSM)
T2 - International Society for the Study of Women's Sexual Health (ISSWSH) expert consensus panel review
AU - Simon, James A.
AU - Goldstein, Irwin
AU - Kim, Noel N.
AU - Davis, Susan R.
AU - Kellogg-Spadt, Susan
AU - Lowenstein, Lior
AU - Pinkerton, Joann V.
AU - Stuenkel, Cynthia A.
AU - Traish, Abdulmaged M.
AU - Archer, David F.
AU - Bachmann, Gloria
AU - Goldstein, Andrew T.
AU - Nappi, Rossella E.
AU - Vignozzi, Linda
N1 - Funding Information:
Received February 1, 2018; revised and accepted March 20, 2018. From the 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, Ram-bam 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; and 14Gynecological Endocrinology Research Unit, Sexual Medicine and Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy. 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 Pharma-lab, 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., Therapeu-ticsMD. Stock Shareholder: Sermonix Pharmaceuticals; IG—Advisory
Publisher Copyright:
© 2018 by The North American Menopause Society.
PY - 2018/7/1
Y1 - 2018/7/1
N2 - 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.
AB - 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.
KW - Androgens
KW - Dehydroepiandrosterone
KW - Genitourinary
KW - Menopause
KW - Vaginal atrophy
KW - Vulvar atrophy
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U2 - 10.1097/GME.0000000000001138
DO - 10.1097/GME.0000000000001138
M3 - Review article
C2 - 29870471
AN - SCOPUS:85050095350
SN - 1072-3714
VL - 25
SP - 837
EP - 847
JO - Menopause
JF - Menopause
IS - 7
ER -