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

Not Applicable

Completed

• Conditions: Vaginal Atrophy
• Interventions: Device: CO2 intimate; Device: Erbium-yag; Device: CO2 intimate or Erbium-yag

• Registration Number: NCT04039555
• Lead Sponsor: Instituto Palacios

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

Study Timeline

• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Study Start: 2019-09-24
• Primary Completion: 2020-03-31
• Study Completion: 2020-05-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Arm - CO2 intimate	CO2 intimate	Patients will receive 2 sessions of CO2 laser treatment, spaced 4 to 6 weeks apart
Active Arm - Erbium-yag	Erbium-yag	Patients will receive 2 sessions of Erbium-Yag laser treatment, spaced 4 to 6 weeks apart
Sham Arm	CO2 intimate or Erbium-yag	Patients will receive 2 sessions of Erbium-Yag laser or CO2 laser treatment with non-therapeutic energy, spaced between 4 and 6 weeks apart

Primary Outcome Measures

Name	Time	Method
Comparation of 1 series of 2 treatment sessions with Erbium-Yag or intimate CO2RE vs Sham for the symptoms of vulvovaginal atrophy	Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)	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

Name	Time	Method
Differences between CO2RE and Erbium-Yag	Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)	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)	Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)	Analyzing the information registered in the visits performed

Trial Locations

Locations (1)

Instituto Palacios; 🇪🇸 Madrid, Spain