Abstract

Abstract Introduction There is mounting evidence that androgens play an important role, together with estrogens, in the maintenance of genitourinary health. Objective Vaginal prasterone was used to characterize the histological changes associated with the dual androgen - estrogen stimulation of the vaginal wall in the treatment of the genitourinary syndrome of menopause (GSM). Since prasterone is converted to androgens which are subsequently aromatised in estrogens, a group of patients on aromatase inhibitors (AI) was included to isolate changes attributable to androgens. Methods Vaginal biopsies and vulvar pictures were collected before and after 12 weeks of treatment with 6.5 mg intravaginal prasterone daily (Intrarosa®). Eight women with GSM were recruited, including two breast cancer survivors on AI. Results Following treatment, the epithelium showed striking histological improvements, regaining thickness, ridges, active proliferation and glycogen synthesis. In the lamina propria, treatment led to increases in elastin content and nerve endings density. Visual evaluation of the vulva showed reduction of the redness and inflammation in the vestibule and the urethral meatus as well as a relaxation of the vaginal entrance. All observations were consistent between the groups with and without AI. Conclusions Data presented here are believed to be the first demonstration of the beneficial effects of androgens deep into the lamina propria of GSM patients both together with or independently from estrogens. Tissue changes observed could help understand some of the GSM symptomatology improvements observed before on dyspareunia and other sexual function parameters. While further studies are warranted to better understand how androgens and estrogens work synergistically in the treatment of GSM, the data presented here strongly suggest that prasterone has deep beneficial impacts on the urogenital tissue. Disclosure Yes, this is sponsored by industry/sponsor: Endoceutics Clarification: Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Endoceutics

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