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COMPLETED
NCT07858994
NA

Effects of Fractional CO2 Vaginal Laser in Postmenopausal Women With Genitourinary Syndrome of Menopause

Sponsor: Karina Amar Svec

View on ClinicalTrials.gov

Summary

This study evaluated the effects of fractional carbon dioxide (CO2) vaginal laser treatment in postmenopausal women with genitourinary syndrome of menopause. Ten women underwent three fractional CO2 laser sessions at 30 to 40-day intervals. Clinical and vaginal assessments were performed before treatment and during follow-up. Vaginal tissue samples were collected at baseline, approximately one month after completion of treatment, and at long-term follow-up to evaluate histological changes, including collagen, vascularization, and estrogen receptor expression. Participants were followed through the long-term assessment performed approximately one year or more after treatment.

Official title: Effects of Fractional CO2 Laser on Angiogenesis and Collagenesis in Women With Genitourinary Syndrome of Menopause

Key Details

Gender

FEMALE

Age Range

45 Years - 68 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-11-09

Completion Date

2025-07-31

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DEVICE

Fractional CO2 Vaginal Laser

Fractional microablative CO2 vaginal laser treatment was performed using the MTZ40 device with a 360-degree intravaginal probe. Treatment parameters were 28 W, pulse duration of 6.5 ms, and 45 DOTS. Participants received three treatment sessions at 30- to 40-day intervals. During each session, a single pass was performed along the vaginal walls, starting at the vaginal fornix and withdrawing the probe distally in 0.5-cm increments.

Locations (1)

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil