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Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment

NCT07697768 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-07-13

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Blue LED Photobiomodulation

Blue LED photobiomodulation (401 ± 5 nm) delivered through a vaginal light-emitting device. Participants will receive treatment according to the assigned protocol (home-based or outpatient). For participants with Genitourinary Syndrome of Menopause, treatment will consist of 8-minute sessions performed three times per week for a total of 24 sessions. For participants with Bacterial Vaginosis or Vulvovaginal Candidiasis, treatment will consist of 15-minute sessions performed twice weekly for a total of 8 sessions.

Sponsors & Collaborators

  • Escola Bahiana de Medicina e Saude Publica

    collaborator OTHER

  • Patricia Lordelo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2027-06-30
Completion
2028-05-20

Countries

  • Brazil

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 NCT07697768 on ClinicalTrials.gov