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Laser Vaginal Treatment for GSM

NCT04042766 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-27

No results posted yet for this study

Summary

Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.

Conditions

  • Menopausal Urethral Atrophy
  • Vulvar Atrophy

Interventions

PROCEDURE

laser vaginal treatment

Er:YAG laser

Sponsors & Collaborators

  • Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario

    collaborator UNKNOWN

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Patricia Lee, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2025-03-24
Completion
2027-10-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT04042766 on ClinicalTrials.gov