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Clinical Trial

Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment

NCT: NCT07697768 · NOT_YET_RECRUITING

NCT IDNCT07697768
StatusNOT_YET_RECRUITING
Start Date2026-07-30
Completion2028-05-20
SponsorPatricia Lordelo (OTHER)
First posted
Last updated

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.

Frequently Asked Questions

What is Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment?

Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment is a clinical trial registered under NCT07697768. Current status: NOT_YET_RECRUITING.

What is the status of NCT07697768?

The current status of NCT07697768 (Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment) is: NOT_YET_RECRUITING.

When did Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment start?

Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment started on 2026-07-30.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.