Status:
COMPLETED
Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER)
Lead Sponsor:
Instituto Palacios
Conditions:
Vaginal Atrophy
Eligibility:
FEMALE
45+ years
Phase:
NA
Brief Summary
This trial compares the efficacy of two different laser treatments for vaginal atrophy symptoms between them and with sham treatment. Patients will be randomized to one of the two lasers or sham treat...
Detailed Description
Patients over 45 years of age with one or more AVV symptoms who wish to participate in the study will be included, 2 laser sessions spaced one of another 4-6 weeks, and final tracking visit 4-6 weeks ...
Eligibility Criteria
Inclusion
- Women older than 45 years with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity.
Exclusion
- Hormone treatment in the last three months for vulvovaginal atrophy
- Treatment with vaginal moisturizers in the last week for vulvovaginal atrophy
- Laser treatment in the last 12 months.
- Acute and recurrent infections of the urinary tract in the last 3 months.
- Acute genital infections
- Vaginal prolapse
- Alterations in the area to be treated, such as lacerations, abrasions or ulcers (time of resolution at medical discretion)
- Chronic decompensated noncommunicable diseases
- Women who are pregnant or have given birth in the last 3 months
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04039555
Start Date
September 24 2019
End Date
May 30 2020
Last Update
February 11 2021
Active Locations (1)
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1
Instituto Palacios
Madrid, Spain, 28009