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

Vaginal Atrophy Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039555
• Other study ID #: COER
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

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)