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Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause

NCT03754205 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-14

No results posted yet for this study

Summary

This study evaluates the clinical, histopathological, cytological and microbiological efficacy of Microablative Fractional CO2 laser intravaginally administered in postmenopausal women with Genitourinary Syndrome of Menopause. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.

Conditions

  • Vaginal Atrophy

Interventions

DEVICE

Microablative Fractional CO2 laser

3 therapies intravaginally administered will be applied at monthly intervals

Sponsors & Collaborators

  • IRCCS San Raffaele

    collaborator OTHER

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Stavros Athanasiou, Associate Proffesor · National and Kapodistrian University of Athens, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2020-04-15
Completion
2021-01-15

Countries

  • Greece

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 NCT03754205 on ClinicalTrials.gov