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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm - CO2 intimate | Active Comparator | Patients will receive 2 sessions of CO2 laser treatment, spaced 4 to 6 weeks apart |
|
| Active Arm - Erbium-yag | Active Comparator | Patients will receive 2 sessions of Erbium-Yag laser treatment, spaced 4 to 6 weeks apart |
|
| Sham Arm | Sham Comparator | Patients will receive 2 sessions of Erbium-Yag laser or CO2 laser treatment with non-therapeutic energy, spaced between 4 and 6 weeks apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 intimate | Device | Two sessions with CO2 intimate laser for vaginal symptoms treatment |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Palacios | Madrid | 28009 | Spain |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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It is a single blind study
| Erbium-yag | Device | Two sessions with Erbium-yag laser for vaginal symptoms treatment |
|
| CO2 intimate or Erbium-yag | Device | Two sessions of one of the two lasers with no therapeuthical energy |
|
Analyzing the information registered in the visits performed |
| Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks) |