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New treatment option for Genitourinary Syndrome of Menopause
Official title Er:YAG Laser Combined With Vaginal Estriol for Genitourinary Syndrome of Menopause
ClinicalTrials.gov ID: NCT06873971
What this study is testing
What is Topical estrogen therapy based on estriol (E3)?
Topical estrogen therapy based on estriol (E3) is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for genitourinary syndrome of menopause.
Also referred to as Estriol ( E3), Vaginal estriol ( E3).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 70, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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).
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.