Clinical Trial

Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment

Not Yet Recruiting
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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 Details
NCT Number NCT07697768
Lead Sponsor Patricia Lordelo
Collaborators: Escola Bahiana de Medicina e Saude Publica
Conditions Genitourinary Syndrome of Menopause (GSM), Bacterial Vaginosis, Vulvovaginal Candidiasis (VVC)
Enrollment 150 participants
Start Date 2026-07-30
Primary Completion 2027-06-30 (estimated)
Study Completion 2028-05-20 (estimated)
Updated on ClinicalTrials.gov 2026-07-13