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Laser Therapy for Treatment of Genitourinary Syndrome of Menopause (GSM) in Postmenopausal Women

NCT05305209 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2022-05-18

No results posted yet for this study

Summary

This is a prospective, multi-centre, double blinded, randomized controlled trial, which will be conducted under a common protocol.

The aim of this study is to evaluate the efficacy of vaginal laser for treatment of GSM (Genitourinary Syndrome of Menopause) compared to the sham procedure in postmenopausal women.

The study population is female subjects \> 18 years old with symptoms of genitourinary syndrome of menopause (GSM) who have not menstruated for at least 5 years.

Conditions

  • Genitourinary Syndrome of Menopause

Interventions

OTHER

Intervention group

The patients will receive 12 minutes of intravaginal application with an average power of 1 watios and total applied energy of 720J and an extracavitary application for 4 minutes with an average power of 3 watios and a total dose of 720J with all effects at 200%, twice a week for 6 weeks.

OTHER

Control Group

The patients will receive 12 minutes of intravaginal application and 4 minutes of extracavitary application, twice a week for 6 weeks. The difference compared to the intervention of group 1 is that the device will be off and therefore will not emit energy.

Sponsors & Collaborators

  • Antonia Maria Ruiz Moreno

    collaborator UNKNOWN

  • María Dolores Martínez Colmena

    collaborator UNKNOWN

  • María del Carmen Iniesta Moreno

    collaborator UNKNOWN

  • María Lydia Serra Llosa

    collaborator UNKNOWN

  • University of Malaga

    lead OTHER

Principal Investigators

  • Rocío Martín-Valero, PhD · University of Malaga

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2022-07-01
Completion
2022-12-15

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 NCT05305209 on ClinicalTrials.gov