James A Simon1, Irwin Goldstein2, Noel N Kim3, Susan R Davis4, Susan Kellogg-Spadt5, Lior Lowenstein6, JoAnn V Pinkerton7, Cynthia A Stuenkel8, Abdulmaged M Traish9, David F Archer10, Gloria Bachmann11, Andrew T Goldstein12, Rossella E Nappi13, Linda Vignozzi14. 1. IntimMedicine Specialists, George Washington University, Washington, DC. 2. Sexual Medicine, Alvarado Hospital, San Diego, CA. 3. Institute for Sexual Medicine, San Diego, CA. 4. Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic, Australia. 5. Center for Pelvic Medicine, Rosemont, PA. 6. Department of Obstetrics and Gynecology, Rambam Health Care Campus, Technion School of Medicine, Haifa, Israel. 7. The North American Menopause Society. 8. University of California, San Diego, School of Medicine, La Jolla, CA. 9. Department of Urology, Boston University School of Medicine, Boston, MA. 10. CONRAD Clinical Research Center, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA. 11. Department of Obstetrics, Gynecology and Reproductive Sciences, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ. 12. Center for Vulvovaginal Disorders. 13. Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS S. Matteo Foundation, University of Pavia, Pavia, Italy. 14. Gynecological Endocrinology Research Unit, Sexual Medicine and Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.
Abstract
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.
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.
Authors: Zachary J Solomon; Jorge Rivera Mirabal; Daniel J Mazur; Taylor P Kohn; Larry I Lipshultz; Alexander W Pastuszak Journal: Sex Med Rev Date: 2018-11-30