Low-level Laser Therapy in Genitourinary Symptoms of Menopause

What this trial studies

The study will employ a prospective single-arm design involving menopausal women who present with genitourinary symptoms of menopause (GSM). Due to the preliminary nature of this study and the absence of a control group, the primary objective is to evaluate the feasibility and potential efficacy of low-level laser therapy in alleviating GSM in this population.

Conditions in scope

• Menopause Related Conditions

Interventions

• Low-level laser therapy (Device) — Low-level laser therapy would be introduced via a vaginal probe (gain medium: Gallium-Aluminum-Arsenide, wavelength 660nm) for 30 minutes per treatment, once a week, for 8 courses.

Who can join

Women only · Ages 45 Years to 85 Years

Inclusion criteria

• Menopause women
• With genitourinary symptoms of menopause

Exclusion criteria

• Acute or chronic infection of the genitourinary tract
• Advanced pelvic organ prolapse (\>= stage 2 on pelvic organ prolapse quantification system)
• History of pelvic malignancy
• Unstable blood pressure
• Fever
• Abnormal sensory nerve
• Abnormal coagulation

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2024-01-12
• Primary completion: 2025-07-04
• Last update posted: 2026-03-18
• First posted: 2023-10-10

Sponsor & contact

Lead sponsor: National Taiwan University Hospital (Other)

Collaborators: National Taiwan University Hospital Beihu Branch

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Vaginal health (20 weeks)
  Vaginal health index, each of these 5 items is evaluated by means of a scale from 1 (none) to 5 (excellent) and then the average of the scores is calculated. A value of ≤15 (= cut-off) is generally considered for the diagnosis of low vaginal health.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.