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CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer

NCT04517370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-03-12

No results posted yet for this study

Summary

Given the need for an effective, non-hormonal treatment for Genitourinary syndrome of menopause GSM) symptoms in breast cancer survivors, the reported efficacy of fractional CO2 laser as such a treatment in retrospective studies, the study aims to evaluate the efficacy of CO2 laser for the treatment of GSM in breast cancer patients, in a prospective, randomized, blinded, placebo-controlled trial.

Conditions

Interventions

DEVICE

Fractional/Pixel CO2 laser

The treatment is done with a specialized vaginal applicator which allows treatment of vagina, using the Femilift fractional micro ablative CO2 laser system (Alma Lasers, Israel), according to the usual protocol (Laser mode: Pulse, Energy: 40-80 mj/pulse). Before treatment, 5ml of topical anesthetic ointment (10% lidocaine in Vaseline base) will be spread in the vagina and on the vestibule for 30 minutes in both groups to avoid pain from the laser, as well as to allow the comparison between the groups (patients in both groups will not experience pain and therefore will remain blinded to their allocation).

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Ahinoam Lev-Sagie, MD · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2023-06-30
Completion
2023-12-30

Countries

  • Israel

Study Locations

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Entities

Diseases

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 NCT04517370 on ClinicalTrials.gov