Double-blind Randomized Study on the Effect of Non-hormonal Gel Application to the Genital Area of Women in the Menacme With Sexual Dysfunction

In this study, 60 sexually active (having a male partner, boyfriend or husband) female volunteers will be included. All patients will undergo gynecological evaluation of the vulvar area and the vaginal mucosa before and after the treatment, by means of visual inspection and speculum examination.

Volunteers will be requested to apply once a day, for four weeks, a small amount of gel to the dry area (vulva), followed by a gentle massage to promote the absorption of the product.

For the time of the study, volunteers will be asked not to change personal hygiene products, e.g., moisturizers, soaps, deodorants, etc. Volunteers will be instructed to fill out the "diary of use" with the dates of product application and notes about feelings of discomfort or subjective reactions, if any. In the final visit, volunteers will answer the FSFI questionnaire (see Annex 1). All variables in the questionnaire (comfort during sexual intercourse, hydration and softness of genital tissue) will undergo a descriptive analysis.

In the first moment of the study, patients will receive the FSFI (Female Sexual Function Index) questionnaire, self-applied and validated for the Portuguese language in Brazil (Thiel et al., 2008). Then, the estronization of external genital organs will be assessed by gynecological exam.

Patients will be randomly assigned to four groups: group A and B (A and B - 30 and 30 patients in the menacme, following the order defined by the computer-generated randomization list.