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This study looks at the use of an Er:YAG laser together with vaginal estriol (E3) therapy in women with genitourinary syndrome of menopause. Postmenopausal women aged 45-70 with at least one moderate symptom of the syndrome (such as vaginal dryness, burning, or painful intercourse) may take part. Conducted by University of Nove de Julho, this study without an assigned phase is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion criteria * Postmenopausal women (45-70 years of age). * At least one of moderate symptom of GSM (vaginal dryness, burning sensation, dyspareunia, and persistent leukorrhea), defined by ≥ 4 on Visual Analog Scale (VAS) ranging from 0 to 10. * Vaginal pH ≥5.0 at baseline assessment. * Not having undergone hormone replacement therapy (vaginal or systemic) in the previous six months. * No use of vaginal moisturizers in the previous 30 days. * Demonstrated capacity and willingness to provide written informed consent and adhere to study protocols. Exclusion criteria * Vaginal or vulvar energy-based interventions (e.g., laser, radiofrequency) in the previous six months. * Abnormal cervical cytology, specifically ASCUS, LSIL, or HSIL, documented in the previous six months. * Systemic corticosteroid therapy administered in the previous 90 days. * Body mass index (BMI) ≥35 kg/m². * Presence of abnormal uterine bleeding in the previous 30 days. * History of vaginal surgery in the previous 180 days or grade II or higher uterine prolapse (POP-q). * History of malignant neoplasms or exposure to vaginal radiotherapy. * Diagnosis of severe liver or kidney disease, autoimmune disease, or severe psychiatric disorder.