Menopausal Genitourinary Syndrome
Conditions
Interventions
The patients will be randomized and allocated to two groups in a 1:1 ratio - 18 patients per group: 1) Moisturizing polymer + 10% glycolic extract of Brassica var. capitata (cabbage) (Intervention Gro
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFM/USP
Eligibility
Sex/Gender
Female
Age
50 Years to 65 Years
Inclusion criteria
Inclusion criteria: Woman, age equal to or greater than 50 years and less than 65 years. Clinical menopause for at least 3 years and presence of GSM - Genitourinary Syndrome of Menopause - symptoms according to established diagnostic criteria. FSH (follicle-stimulating hormone) measurement > 25 IU/ml and estradiol < 20 pg/mL, when it is not possible to predict the date of the last menstrual period. Diagnosis of genitourinary syndrome identified by clinical data and supported by the Vaginal Health Index questionnaire. Negative cervical cytology exam, within the routine timeframe recommended by the Ministry of Health/Instituto Nacional do Câncer (INCA)
Exclusion criteria
Exclusion criteria: Allergy to cabbage, broccoli, kale, or any plant from the Brassicaceae family. Patients with severe depression or any other mental health condition that impairs study participation or other study requirements. Intact hymen. Altered oncotic colpocytology of the cervix and/or vagina. Active or recurrent genital infections (genital herpes or candidiasis). Active connective tissue diseases. Congenital or acquired immunosuppression. Decompensated diabetes mellitus. Differential diagnosis of vulvar pathology (atrophic lichen sclerosus, vulvar intraepithelial neoplasia, and vulvar Paget's disease). Decompensated thyroid disorders. Use of systemic or local steroid hormones or herbal substances such as teas, sitz baths, compounded or commercial herbal products, or hormonal therapy within the past 3 months. Patients with decompensated chronic diseases. Acquired immunodeficiency virus carriers. Patients who have undergone pelvic irradiation, pelvic surgeries, or hysterectomy for malignant disease. Patients with current or ongoing neoplasms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is hoped to find a significant improvement in urogenital symptoms, which will be verified using the VHI (Vaginal Health Index). Indicators will be taken as changes in the VHI scores, with an expected increase of at least 10% compared to the initial values.;The primary endpoint will also be female sexual function, assessed by the IFSF (Female Sexual Function Index). For this endpoint, the parameters will include a positive change in IFSF scores, with an expected increase of at least 15% compared to pre-treatment measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is hoped to find a significant improvement in the participants' quality of life. This improvement will be verified using the WHQ (Womens Health Questionnaire), a validated instrument for measuring various aspects of women's health and well-being. The specific parameters that will be observed include increases in overall WHQ scores, with an expected increase of at least 20% in relation to the scores obtained at the start of the study. This increase in WHQ scores will indicate an improvement in the participants' general perception of well-being, emotional and physical health, reflecting positively on the efficacy of topical non-hormonal therapy for menopausal symptoms | — |
Countries
Brazil
Contacts
Public ContactCaio Portella
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFM/USP
Outcome results
None listed