Status:
WITHDRAWN
Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.
Lead Sponsor:
University of Nove de Julho
Conditions:
Vulvovaginal Atrophy
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
Menopause is a physiological event and is defined as the loss of ovarian follicular activity, with consequent permanent cessation of menstrual cycles. Its diagnosis is made retrospectively after 12 mo...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04487392
Start Date
December 15 2020
End Date
December 30 2021
Last Update
June 29 2023
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