Back to results

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

Primary Purpose

Vaginal Atrophy

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

CO2 intimate

Erbium-yag

CO2 intimate or Erbium-yag

About this trial

This is an interventional treatment trial for Vaginal Atrophy

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Instituto Palacios

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Arm - CO2 intimate

Active Arm - Erbium-yag

Sham Arm

Arm Description

Patients will receive 2 sessions of CO2 laser treatment, spaced 4 to 6 weeks apart

Patients will receive 2 sessions of Erbium-Yag laser treatment, spaced 4 to 6 weeks apart

Patients will receive 2 sessions of Erbium-Yag laser or CO2 laser treatment with non-therapeutic energy, spaced between 4 and 6 weeks apart

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Changes in the Vulvar and Vaginal Health Index (VVHI)

Analyzing the information registered in the visits performed

Full Information

NCT ID

NCT04039555

First Posted

April 22, 2019

Last Updated

February 10, 2021

Sponsor

Instituto Palacios

1. Study Identification

Unique Protocol Identification Number

NCT04039555

Brief Title

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

Acronym

COER

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

September 24, 2019 (Actual)

Primary Completion Date

March 31, 2020 (Actual)

Study Completion Date

May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto Palacios

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginal Atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Masking Description

It is a single blind study

Allocation

Randomized

Enrollment

136 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Arm - CO2 intimate

Arm Type

Active Comparator

Arm Description

Patients will receive 2 sessions of CO2 laser treatment, spaced 4 to 6 weeks apart

Arm Title

Active Arm - Erbium-yag

Arm Type

Active Comparator

Arm Description

Patients will receive 2 sessions of Erbium-Yag laser treatment, spaced 4 to 6 weeks apart

Arm Title

Sham Arm

Arm Type

Sham Comparator

Arm Description

Patients will receive 2 sessions of Erbium-Yag laser or CO2 laser treatment with non-therapeutic energy, spaced between 4 and 6 weeks apart

Intervention Type

Device

Intervention Name(s)

CO2 intimate

Intervention Description

Two sessions with CO2 intimate laser for vaginal symptoms treatment

Intervention Type

Device

Intervention Name(s)

Erbium-yag

Intervention Description

Two sessions with Erbium-yag laser for vaginal symptoms treatment

Intervention Type

Device

Intervention Name(s)

CO2 intimate or Erbium-yag

Intervention Description

Two sessions of one of the two lasers with no therapeuthical energy

Primary Outcome Measure Information:

Title

Comparation of 1 series of 2 treatment sessions with Erbium-Yag or intimate CO2RE vs Sham for the symptoms of vulvovaginal atrophy

Description

Analyzing the differences in % the cytological maturity index, changes in the intensity of symptoms and PH range of normality (3,5- 4.5).

Time Frame

Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)

Secondary Outcome Measure Information:

Title

Differences between CO2RE and Erbium-Yag

Description

Analyzing the differences in % the cytological maturity index, changes in the intensity of symptoms and PH range of normality (3,5- 4.5).

Time Frame

Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)

Title

Changes in the Vulvar and Vaginal Health Index (VVHI)

Description

Analyzing the information registered in the visits performed

Time Frame

Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Instituto Palacios

City

Madrid

ZIP/Postal Code

28009

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs