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Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.

NCT04021966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-01-10

No results posted yet for this study

Summary

Purpose of the trial is to study the efficacy of fractional laser in alleviating genitourinary symptoms in menopausal women.

Primary outcome of the study is the efficacy of the laser procedure, intended as the amelioration of the severity of most bothersome symptom (MBS).

Therefore we conducted a single center, double-blinded randomized placebo-controlled cross-over trial.

Conditions

  • Vulvovaginal Atrophy

Interventions

PROCEDURE

Vaginal laser application

One laser treatment cycle consists of 3 vaginal laser applications with a 4-weeks interval. Each application lasts around 5 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators. A vaginal probe will be gently inserted and manually rotated to provide a 360° treatment of the vaginal mucosa.

Sponsors & Collaborators

  • prof. dr. Jan Deprest

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2021-09-27
Completion
2021-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04021966 on ClinicalTrials.gov