Status:
NOT_YET_RECRUITING
Effects of Erbium-Yag Laser in Women With Genitourinary Syndrome of Menopause Undergoing Estrogen Therapy
Lead Sponsor:
University of Nove de Julho
Conditions:
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
45-70 years
Phase:
NA
Brief Summary
Chronic hypoestrogenism in postmenopausal women significantly impacts the urogenital epithelium, leading to Genitourinary Syndrome of Menopause (GSM) and increasing susceptibility to gynecological inf...
Detailed Description
Chronic, progressive hypoestrogenism, without adequate treatment during the postmenopausal period, significantly affects the epithelium of the urogenital system, causing Genitourinary Syndrome of Meno...
Eligibility Criteria
Inclusion
- Women with amenorrhea present for at least 24 months.
- Women with amenorrhea for more than 12 months and FSH levels \> 30 mUI/MI and estradiol \< 30 mUI/MI, collected specifically for this research.
- Age between 45 to 70 years.
- Vaginal pH measurement \>= 5.
- Present at least one of these moderate symptoms of GSM (dyspareunia, dryness, burning, and persistent leukorrhea). Each of these will be assessed separately by the patient, according to the Visual Analog Scale (VAS) criteria, from 0 (absence of symptoms) to 10 (very severe symptoms). Moderate symptoms will be considered as values equal to or greater than 4.
- Not users of hormonal replacement therapy (oral or systemic) in the last 6 months.
- Not users of vaginal moisturizers in the last 30 days.
Exclusion
- Vaginal treatments using energy in the last 6 months.
- Patients with altered Pap smear results with cellular changes such as ASCUS, LSIL, or HSIL in the last 6 months.
- Corticotherapy in the last 90 days.
- BMI \>= 35 kg/m².
- Abnormal uterine bleeding in the last 30 days.
- History of vaginal surgeries in the last 180 days or uterine prolapse Grade II or higher.
- Patients with a prior diagnosis of malignant neoplasms of any nature or currently undergoing treatment; prior vaginal radiotherapy, severe liver and kidney diseases already diagnosed by previous tests, autoimmune diseases, and severe psychiatric disorders.
Key Trial Info
Start Date :
December 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06873971
Start Date
December 10 2025
End Date
July 20 2026
Last Update
December 15 2025
Active Locations (1)
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1
Universidade Nove de Julho
São Paulo, São Paulo, Brazil, 01525-000