Status:
TERMINATED
The Use of Laser in the Treatment of Atrophic Vulvovaginitis
Lead Sponsor:
Hospital Italiano de Buenos Aires
Conditions:
Lasers
Atrophy of Vagina
Eligibility:
FEMALE
Phase:
NA
Brief Summary
This study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo.
Detailed Description
Thermal laser treatments are proposed as the newest treatments for atrophy. Through the thermal effect it would stimulates de mucosa, enhances the collagen component and the vascularization. Collagen ...
Eligibility Criteria
Inclusion
- Menopause women with vulvovaginal symptoms of atrophy
- No previous estrogen treatment for the last 30 days
- Active sexual life (vaginal penetration)
- Accept to participate
- Pap atrophy or hypotrophy in the last year
Exclusion
- Vulvovaginal diseases
- Abnormal uterine bleeding
- Antidepressants drugs
- Uncontrolled diabetes
- Cervical intraepithelial lesions or cancer
- Photosensitized or under treatment with photosensibilized drugs
- Collagen diseases
- Vulvovaginal infections in the last 15 days
- Immunosuppressed patients or under immunosuppressed treatments
Key Trial Info
Start Date :
September 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04297319
Start Date
September 20 2019
End Date
December 1 2021
Last Update
August 9 2022
Active Locations (1)
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1
Hospital Italiano de Buenos Aires
CABA, Argentina, 1199