Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT04487392
Eligibility Criteria:
Inclusion Criteria:
* postmenopausal women (amenorrhea for less than 12 months);
* presence one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation and vaginal burning);
* Vaginal Heath Index ≤ 15 (signs of atrophy);
* normal cytopathology of uterine cervix in the last year.
Exclusion Criteria:
* previous or current history of gynecological neoplasia;
* who used hormonal or non-hormonal treatment for vulvovaginal symptoms of menopause;
* current or recent genitourinary lesions or infectious processes in the genitourinary tract (last month);
* current or recent (last month) systemic treatment with antifungals, antibiotics or corticosteroids;
* presence of genital prolapse;
* presence of contraindications to the use of vaginal estrogen (current, previous or suspected diagnosis of breast cancer, malignant estrogen-dependent tumors, uninvestigated uterine bleeding, untreated endometrial hyperplasia, deep venous thrombosis and current or previous pulmonary thromboembolism, known thrombophilia, recent or active arterial disease, acute liver disease, porphyria, use of drugs that may interact with estriol and hypersensitivity to the components of the vaginal cream formula).
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT04487392
Study Brief:
Protocol Section:
NCT04487392