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

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)

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Atrophy
• Intervention / Treatment: Device: CO2 intimate; Device: Erbium-yag; Device: CO2 intimate or Erbium-yag

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 of the last laser session.

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

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Instituto Palacios

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Instituto Palacios

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: COER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No