Er:YAG laser plus vaginal estriol for menopausal genitourinary symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double‑blind study enrolling 60 postmenopausal women with genitourinary syndrome of menopause to compare combined Er:YAG laser plus topical estriol versus estriol with a sham laser. All participants receive an initial 14‑day course of intravaginal estriol followed by twice‑weekly maintenance until completion of three laser sessions given at four‑week intervals. One group receives therapeutic Er:YAG laser treatments while the control group receives a minimal‑fluence sham application to preserve blinding. Outcomes include symptom scores, vaginal pH, and vaginal microbiome/trophism measures over the treatment course.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universidade Nove de Julho
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Stella Zamuner
• Email: stella.rz@uni9.pro.br
• Phone: +55 11 3385-9241

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.