Trials / Completed
CompletedNCT04021966
Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- prof. dr. Jan Deprest · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-08-01
- Primary completion
- 2021-09-27
- Completion
- 2021-12-31
- First posted
- 2019-07-16
- Last updated
- 2022-01-10
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04021966. Inclusion in this directory is not an endorsement.