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Er:YAG Laser Combined With Vaginal Estriol for Genitourinary Syndrome of Menopause

RecruitingNAAges 45 Years - 70 YearsFemaleUniversity of Nove de Julho
NCT06873971 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Chronic hypoestrogenism in postmenopausal women significantly impacts the urogenital epithelium, leading to Genitourinary Syndrome of Menopause (GSM) and increasing susceptibility to gynecological infections due to vaginal pH elevation. Therapies using the Erbium:YAG (Er:YAG) 2940nm laser and low dose topical estrogen have demonstrated efficacy in improving vaginal trophism and restoring microbiota balance. This randomised, double-blind clinical study aims to assess the effects of combining Er: YAG laser therapy with vaginal estriol compared with estriol therapy alone in postmenopausal women with GSM. Sixty patients will be recruited and randomly assigned to two groups. All participants will receive low-dose topical estrogen therapy (estriol cream ) for 14 days, followed by twice-weekly applications until completing three laser sessions at four-week intervals. Group 1 (Sham) will receiv

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📋 Eligibility rules (as published)
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.
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What it tests

  • Topical estrogen therapy based on estriol (E3)
  • Active Er:YAG Laser
  • Sham Er:YAG laser (minimal fluence)
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Where

1 site
Universidade Nove de Julho
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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