Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
Starting soon · Not applicable
Conditions studied: Genitourinary Syndrome of Menopause (GSM), Bacterial Vaginosis, Vulvovaginal Candidiasis (VVC)
In brief
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.
Key facts
- Study ID
- NCT07697768
- Run by
- Patricia Lordelo
- People needed
- 150
- Starts
- 2026-07-30
- Expected to finish
- 2028-05-20
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women aged 18 to 75 years.
- Clinical and/or laboratory-confirmed diagnosis of Genitourinary Syndrome of - Menopause (GSM), Bacterial Vaginosis (BV), or Vulvovaginal Candidiasis (VVC), according to established diagnostic criteria.
- Ability to understand study procedures and provide written informed consent.
- Willingness to comply with study procedures and follow-up assessments.
You may not qualify if…
- Pregnancy.
- Use of a pacemaker or other implanted electronic medical device.
- Active gynecological malignancy or suspicion of gynecological cancer.
- Neurological and/or psychiatric disorders associated with cognitive impairment that may interfere with understanding study procedures.
- Use of antibiotics, antifungal agents, corticosteroids, or vaginal creams within the previous 30 days in participants diagnosed with BV and/or VVC.
- Suspected or confirmed vulvovaginal conditions other than GSM, BV, or VVC.
- Any condition deemed by the investigators to compromise participant safety or interfere with study participation.
Where it is running
- Escola Bahiana de Medicina e Saúde Pública — Salvador, Estado de Bahia, Brazil
Full record on ClinicalTrials.gov
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