Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER)
NCT ID: NCT04039555
Last Updated: 2021-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2019-09-24
2020-05-30
Brief Summary
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Detailed Description
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Each patient shall be randomly assigned an arm of tto, with laser CO2, or laser Erbium, or sham group
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Active Arm - CO2 intimate
Patients will receive 2 sessions of CO2 laser treatment, spaced 4 to 6 weeks apart
CO2 intimate
Two sessions with CO2 intimate laser for vaginal symptoms treatment
Active Arm - Erbium-yag
Patients will receive 2 sessions of Erbium-Yag laser treatment, spaced 4 to 6 weeks apart
Erbium-yag
Two sessions with Erbium-yag laser for vaginal symptoms treatment
Sham Arm
Patients will receive 2 sessions of Erbium-Yag laser or CO2 laser treatment with non-therapeutic energy, spaced between 4 and 6 weeks apart
CO2 intimate or Erbium-yag
Two sessions of one of the two lasers with no therapeuthical energy
Interventions
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CO2 intimate
Two sessions with CO2 intimate laser for vaginal symptoms treatment
Erbium-yag
Two sessions with Erbium-yag laser for vaginal symptoms treatment
CO2 intimate or Erbium-yag
Two sessions of one of the two lasers with no therapeuthical energy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
45 Years
FEMALE
No
Sponsors
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Instituto Palacios
OTHER
Responsible Party
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Locations
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Instituto Palacios
Madrid, , Spain
Countries
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Other Identifiers
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COER
Identifier Type: -
Identifier Source: org_study_id
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