NCT04039555

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Instituto Palacios · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Vaginal Atrophy

Interventions

Type	Name	Description
DEVICE	CO2 intimate	Two sessions with CO2 intimate laser for vaginal symptoms treatment
DEVICE	Erbium-yag	Two sessions with Erbium-yag laser for vaginal symptoms treatment
DEVICE	CO2 intimate or Erbium-yag	Two sessions of one of the two lasers with no therapeuthical energy

Timeline

• Start date: 2019-09-24
• Primary completion: 2020-03-31
• Completion: 2020-05-30
• First posted: 2019-07-31
• Last updated: 2021-02-11

Locations

1 site across 1 country: Spain