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

NCT04039555 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2021-02-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Instituto Palacios

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2020-03-31
Completion
2020-05-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04039555 on ClinicalTrials.gov