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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04039555
Other study ID # COER
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 24, 2019
Est. completion date May 30, 2020

Study information

Verified date February 2021
Source Instituto Palacios
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 treatment.


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


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date May 30, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 45 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
Spain Instituto Palacios Madrid

Sponsors (1)

Lead Sponsor Collaborator
Instituto Palacios

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
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