Randomized controlled clinical trial, with topical use of estrogen,testosterone, polyacryli cacid and placebo in the treatment of urogenital atrophy in postmenopausal women

Abstract

Urogenital atrophy is a frequent chronic condition in postmenopausal women that causes changes in their quality of life. Recent studies have evaluated new treatment alternatives for this increasingly common complaint among the female population. However, few therapeutic options have been adequately assessed and are currently available. Objective: the aim of this study is to compare the topical use of estrogen, testosterone, polyacrylic acid and placebo in the treatment of urogenital atrophy. Methods: a randomized clinical trial based on 96 postmenopausal women is to be conducted. Women undergoing follow-up care at the Unicamp Climacteric Outpatient Facility will be selected and randomized into four groups for vaginal topical treatment: one group will receive topical estrogen, another group will be given topical testosterone, another group will receive polyacrylic acid and a control group will be given placebo for a period of 12 weeks. Trophism, cytology, pH and vaginal collagen production will be assessed at the beginning and end of treatment. Genital and urologic symptoms, sexuality aspects and levels of serum estradiol, total and free testosterone, follicle-stimulating hormone (FSH), androstenedione, dehydroepiandrosterone, dehydroepiandrosterone sulfate and ShBG will also be evaluated. Statistical analysis will be carried out, using the chi-square test and the ANOVA test. Thus, we hope to contribute towards better management of these women. (AU)