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MonaLisa Touch Randomized Double-Blind Placebo Controlled Study

NCT03331328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-08-14

No results posted yet for this study

Summary

Aim of the study: To assess the efficacy of MonaLisa Touch procedure for the management of genitourinary syndrome of menopause (GSM) in a randomized double-blind placebo controlled study.

Conditions

  • Genitourinary Syndrome of Menopause

Interventions

DEVICE

MonaLisa Touch

MonaLisa Touch is a fractional CO2 laser that has been specially designed with the DEKA pulse to stimulate vaginal tissue. It is delivered in a very precise manner and results in the synthesis of collagen and stratification of the vaginal epithelium with improvement of the vaginal pH and moisturization of the vaginal tissue due to increased blood flow and turgidity of the ground substance from the synthesis of the proteoglycans, hyaluronic acid and collagen.

Sponsors & Collaborators

  • Michigan Institution of Women's Health PC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-13
Primary Completion
2019-07-10
Completion
2019-07-10
FDA Device
Yes

Countries

  • United States

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 NCT03331328 on ClinicalTrials.gov