Brief Summary

Vaginal disorders, including vulvovaginal candidiasis (VVC), bacterial vaginosis (BV), and genitourinary syndrome of menopause (GSM), are highly prevalent conditions that significantly affect women's quality of life and sexual health. These disorders are associated with inflammatory changes, vaginal dysbiosis, and symptoms such as pruritus, abnormal vaginal discharge, dryness, and dyspareunia. In this context, photobiomodulation has emerged as a noninvasive therapeutic approach with anti-inflammatory and tissue-repair properties. This study is a randomized clinical trial designed to compare the therapeutic response to blue LED photobiomodulation (401 ± 5 nm) delivered through home-based and outpatient treatment protocols. A total of 150 women aged 18 to 75 years with a diagnosis of GSM, BV, or VVC will be enrolled and randomly assigned to one of two treatment groups. Clinical and laboratory assessments will be performed before and after treatment. Participants will also complete the Female Sexual Function Index (FSFI) and the 36-Item Short Form Health Survey (SF-36). Outcomes will include the evaluation of gynecological signs and symptoms, sexual function, quality of life, treatment adherence, and adverse events. The anticipated risks are minimal and primarily related to potential discomfort during gynecological examinations and possible embarrassment associated with discussing sensitive health information. The study is expected to demonstrate that photobiomodulation may improve clinical and functional outcomes, representing a safe, non-hormonal therapeutic alternative for the management of vaginal disorders.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

150

participants targeted

Target at P75+ for not_applicable

Timeline

22mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

June 5, 2026

Completed

1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed

17 days until next milestone

Study Start

First participant enrolled

July 30, 2026

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2028

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

June 5, 2026

Last Update Submit

July 9, 2026

Conditions

Genitourinary Syndrome of Menopause (GSM)Bacterial Vaginosis Vulvovaginal Candidiasis (VVC)

Keywords

PhotobiomodulationBlue LEDVaginal DisordersVulvovaginal CandidiasisBacterial VaginosisGenitourinary Syndrome of MenopauseSexual FunctionNon-Hormonal TherapyRandomized Clinical TrialHome-Based TherapyOutpatient Therapy

Outcome Measures

Primary Outcomes (1)

Therapeutic Response to Blue LED Photobiomodulation
PRIMARY OUTCOME Clinical improvement will be assessed based on the proportion of participants exhibiting complete resolution or a reduction in at least one vaginal sign or symptom present at the initial assessment, without worsening of any other assessed sign or symptom. Assessed clinical signs will include hyperemia, edema, leukorrhea, and fissures, classified as present or absent during the gynecological examination. Assessed symptoms will include pruritus, burning sensation, pain, vaginal dryness, and dyspareunia. Signs and symptoms will be evaluated upon the patient's entry into the study and immediately after the completion of all sessions. Additionally, follow-up assessments will take place 30, 60, and 90 days after the completion of therapy. Changes in each sign and symptom will be classified using a three-point Likert scale (improvement, unchanged, or worsening) relative to the baseline assessment.
From enrollment to the end of treatment at 8 weeks in case of women with vaginal atrophy caused by menopause; or From enrollment to the end of treatment at 4 weeks in case of women with vaginal infections.

Study Arms (6)

GSM - Home-Based Blue LED Photobiomodulation

EXPERIMENTAL

Participants diagnosed with Genitourinary Syndrome of Menopause (GSM) will receive blue LED photobiomodulation (401 ± 5 nm) through a home-based protocol. Treatment will be administered for 8 minutes per session, three times per week, totaling 24 sessions. Participants will receive standardized training and instructions regarding device use and treatment procedures.