Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER)

Study Overview
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Brief Summary
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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 treatment.

Detailed Description
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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 of the last laser session. Each patient shall be randomly assigned an arm of tto, with laser CO2, or laser Erbium, or sham group

Official Title
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Clinical Study to Compare the Efficacy of 1 Series of 2 Treatment Sessions With Erbium-Yag Laser or CO2RE Intimate Laser vs Sham (Sham Treatment) for Vulvovaginal Atrophy (Dryness and / or Dyspareunia)

Conditions
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Vaginal Atrophy

Intervention / Treatment
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* Device: CO2 intimate
* Device: Erbium-yag
* Device: CO2 intimate or Erbium-yag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Arm - CO2 intimate<br>Patients will receive 2 sessions of CO2 laser treatment, spaced 4 to 6 weeks apart | Device: CO2 intimate<br>* Two sessions with CO2 intimate laser for vaginal symptoms treatment<br>|
| Active Comparator: Active Arm - Erbium-yag<br>Patients will receive 2 sessions of Erbium-Yag laser treatment, spaced 4 to 6 weeks apart | Device: Erbium-yag<br>* Two sessions with Erbium-yag laser for vaginal symptoms treatment<br>|
| Sham Comparator: Sham Arm<br>Patients will receive 2 sessions of Erbium-Yag laser or CO2 laser treatment with non-therapeutic energy, spaced between 4 and 6 weeks apart | Device: CO2 intimate or Erbium-yag<br>* Two sessions of one of the two lasers with no therapeuthical energy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparation of 1 series of 2 treatment sessions with Erbium-Yag or intimate CO2RE vs Sham for the symptoms of vulvovaginal atrophy | Analyzing the differences in % the cytological maturity index, changes in the intensity of symptoms and PH range of normality (3,5- 4.5). | Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between CO2RE and Erbium-Yag | Analyzing the differences in % the cytological maturity index, changes in the intensity of symptoms and PH range of normality (3,5- 4.5). | Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks) | 
| Changes in the Vulvar and Vaginal Health Index (VVHI) | Analyzing the information registered in the visits performed | Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks) |