Er:YAG laser plus vaginal estriol for menopausal genitourinary symptoms

Effects of Erbium:YAG Laser Combined With Vaginal Estriol Therapy in Postmenopausal Women With Genitourinary Syndrome of Menopause: A Protocol for a Randomised, Double-blind Controlled Trial

This trial will test whether adding Er:YAG laser treatment to low‑dose vaginal estriol helps postmenopausal women with genitourinary syndrome of menopause.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 45 Years to 70 Years
• Sex: Female
• Sponsor: University of Nove de Julho (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06873971 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Postmenopausal women aged 45–70 with at least one moderate GSM symptom (VAS ≥4), baseline vaginal pH ≥5.0, and no vaginal or systemic hormone therapy in the prior six months are ideal candidates.

Not a fit: Women who recently had vaginal energy treatments, abnormal cervical cytology, recent systemic corticosteroids, BMI ≥35 kg/m², recent abnormal uterine bleeding, or recent vaginal surgery are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, combining Er:YAG laser with estriol could provide greater symptom relief and better restoration of vaginal pH and microbiota than estriol alone.

How similar studies have performed: Prior nonrandomized and observational studies have reported improved vaginal trophism and microbiota with Er:YAG laser and with low‑dose topical estrogen, but randomized double‑blind evidence on the combined approach is limited.

Eligibility criteria

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 this trial is running

São Paulo, São Paulo

• Universidade Nove de Julho — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Stella Zamuner

Conditions Genitourinary Syndrome of Menopause; Genitourinary syndrome of menopause; postmenopausal women; Erbium: YAG laser; vaginal microbiome; vaginal estriol