Status:
COMPLETED
Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.
Lead Sponsor:
prof. dr. Jan Deprest
Conditions:
Vulvovaginal Atrophy
Eligibility:
FEMALE
Phase:
NA
Brief 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, inten...
Eligibility Criteria
Inclusion
- Healthy women with menopausal status (\>1 year amenorrhea) AND with moderate to severe symptoms of VVA as measured by the MBS score ≥2.
Exclusion
- Acute or recurrent urogenital infections
- Prolapse ≥ grade 3 according to the Pelvic Organ Prolapse Quantification System
- Hormonal replacement therapy within the last 6 months before study entry
- Use of local estrogens, moisturizers, lubricants or homeopathic preparations within the last 3 months
- Pelvic floor physiotherapy for pelvic floor disorders within the last 3 months
- Any condition that could interfere with study compliance
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04021966
Start Date
August 1 2019
End Date
December 31 2021
Last Update
January 10 2022
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000