Using light therapy to treat menopause-related vaginal issues
Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause: Randomized Controlled Clinical Trial
NA · Centro de Atenção ao Assoalho Pélvico · NCT04902794
This study is testing a new light therapy to see if it can help menopausal women with vaginal dryness and discomfort.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Centro de Atenção ao Assoalho Pélvico (other) |
| Locations | 1 site (Salvador, Bahia) |
| Trial ID | NCT04902794 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of a 405 nm light emitting diode in treating vulvovaginal atrophy associated with menopause. The study will begin with a pilot phase involving 10 volunteers, followed by a randomized, blinded trial with 58 participants. Eligible candidates are menopausal women experiencing symptoms such as vaginal dryness, irritation, and discomfort during intercourse. The trial will be conducted at the Pelvic Floor Care Center in Salvador, Bahia.
Who should consider this trial
Good fit: Ideal candidates are menopausal women up to 65 years old with clinical signs of vulvovaginal atrophy.
Not a fit: Patients currently undergoing hormone replacement therapy or with vaginal infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for menopausal women suffering from vulvovaginal atrophy.
How similar studies have performed: While this approach is relatively novel, similar studies using light therapy for other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * menopausal women up to 65 years of age * presence of clinical signs and symptoms of Menopause Genitourinary Syndrome :dryness and irritation of the vagina, pruritus, pain or discomfort in sexual intercourse, bleeding after sexual intercourse * voluntarily participate in the research. Exclusion Criteria: * patients undergoing hormone replacement for less than 6 months * diagnosis of vaginal infection * difficulty in understanding the proposed instruments * patients with chronic neurological degenerative diseases.
Where this trial is running
Salvador, Bahia
- Instituto Patrícia Lordelo — Salvador, Bahia, Brazil (RECRUITING)
Study contacts
- Study coordinator: Patrícia Lôrdelo
- Email: pvslordelo@hotmail.com
- Phone: 557188592400/3330- 1640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrophy, Vaginal, Phototherapy, Menopause, Women