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

NCT04039555 | Completed

• 1 other identifier: COER
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Differences between CO2RE and Erbium-Yag

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

• Changes in the Vulvar and Vaginal Health Index (VVHI)

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

Study Arms (3)

Active Arm - CO2 intimate

ACTIVE COMPARATOR

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

Device: CO2 intimate

Active Arm - Erbium-yag

ACTIVE COMPARATOR

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

Device: Erbium-yag

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

Device: CO2 intimate or Erbium-yag

Interventions

CO2 intimate DEVICE

Two sessions with CO2 intimate laser for vaginal symptoms treatment

Active Arm - CO2 intimate

Erbium-yag DEVICE

Two sessions with Erbium-yag laser for vaginal symptoms treatment

Active Arm - Erbium-yag

CO2 intimate or Erbium-yag DEVICE

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

Sham Arm

Eligibility Criteria

• Age: 45 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Palacios: lead

Study Sites (1)

Instituto Palacios

Madrid, 28009, Spain

Location

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: It is a single blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: July 31, 2019
• Study Start: September 24, 2019
• Primary Completion: March 31, 2020
• Study Completion: May 30, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)