RBR-4vknryn招募中Unknown

Randomized clinical study of the efficacy and clinical safety of Brassica oleracea in the treatment of Menopausal Genitourinary Syndrome - pilot study with analysis of quality of life and urogenital symptoms

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFM/USP0 个研究点开始时间: 2023年12月27日最近更新: 2024年1月23日

试验速览

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•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)

•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

发起方

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFM/USP