Actively Recruiting
Effects of Erbium:YAG Laser Combined With Vaginal Estriol Therapy in Postmenopausal Women With Genitourinary Syndrome of Menopause: A Randomised, Double-Blind Controlled Trial
Led by University of Nove de Julho · Updated on 2026-04-23
60
Participants Needed
1
Research Sites
7 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Genitourinary Syndrome of Menopause (GSM) in postmenopausal women, a condition caused by chronic low estrogen levels that affect the urogenital tract and increase the risk of infections due to higher vaginal pH. This randomized, double-blind clinical trial aims to compare the effects of combining Erbium:YAG (Er:YAG) laser therapy with low-dose vaginal estriol cream against estriol therapy alone in improving symptoms and vaginal health in women aged 45 to 70 years with moderate GSM symptoms. Participants will all use low-dose vaginal estriol cream for 14 days daily, then twice weekly until completing three laser sessions spaced four weeks apart. One group will receive a sham laser treatment with minimal energy that does not affect tissues but maintains blinding, while the other group will receive an active Er:YAG laser treatment targeting the vaginal canal and external vulvar areas with specific energy settings. The laser device used is a 2940 nm wavelength Smooth XS Dynamics Dualis. During the study, assessments will be done at baseline, 30 days after each laser session, and four months after the third session. Researchers will measure vaginal health using the Vaginal Health Index, evaluate symptoms via a visual analog scale, analyze vaginal microbiota with gene sequencing, and collect quality of life and sexual health questionnaire data. Safety and statistical analyses will be conducted to compare the effects between groups over time.
CONDITIONS
Brief Title
Er:YAG Laser Combined With Vaginal Estriol for Genitourinary Syndrome of Menopause
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women aged 45 to 70 years
- Moderate symptoms of GSM (vaginal dryness, burning, pain during sex, persistent discharge) with a score of 4 or higher on a 0-10 scale
- Vaginal pH of 5.0 or higher at baseline
- No hormone therapy (vaginal or systemic) in the last 6 months
- No use of vaginal moisturizers in the last 30 days
- Ability and willingness to give written informed consent and follow study procedures
You will not qualify if you...
- Vaginal or vulvar energy-based treatments (e.g., laser, radiofrequency) in the last 6 months
- Abnormal cervical cytology (ASCUS, LSIL, HSIL) in the last 6 months
- Systemic corticosteroid therapy in the last 90 days
- Body mass index (BMI) of 35 kg/m² or higher
- Abnormal uterine bleeding in the last 30 days
- Vaginal surgery in the last 180 days or grade II or higher uterine prolapse
- History of malignant neoplasms or vaginal radiotherapy
- Severe liver or kidney disease, autoimmune disease, or severe psychiatric disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 to 14 weeks
Participants receive low-dose vaginal estriol cream daily for 14 days followed by twice weekly applications while undergoing three laser sessions spaced about 4 weeks apart. The laser sessions include either active Er:YAG laser treatment or sham laser treatment depending on group assignment.
3 laser treatment visits spaced 4 weeks apart with ongoing vaginal estriol application
Duration - 4 months after treatment ends
Participants are assessed four months after the third laser session to evaluate the long-term effects of the treatment on vaginal health and symptoms.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Universidade Nove de Julho
São Paulo, São Paulo, Brazil, 01525-000
Actively Recruiting
Research Team
S
Stella Zamuner
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here