Vaginal treatment for menopause symptoms using CO2 laser
Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy, a Randomized Controlled Trial
NA · University of California, Irvine · NCT06691178
This study is testing if a CO2 laser treatment can help relieve vaginal dryness and discomfort in women going through menopause who can't use hormone therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, Irvine (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT06691178 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of CO2 laser treatment on Genitourinary Syndrome of Menopause (GSM), a condition characterized by vaginal dryness and discomfort due to decreased estrogen levels. Using advanced imaging techniques like optical coherence tomography, the study aims to document changes in the vaginal epithelium before and after treatment. The goal is to provide a non-hormonal alternative for women who cannot use traditional hormone therapies due to health concerns. Participants will be monitored for their response to the laser therapy over time.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women seeking relief from GSM symptoms who are willing to forego other treatments during the study.
Not a fit: Patients with a history of pelvic radiation, those currently on hormone replacement therapy, or those with recurrent urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for women suffering from GSM by providing an effective non-hormonal therapy.
How similar studies have performed: While the use of CO2 laser therapy in dermatology has shown success, its application in treating GSM is relatively novel and has limited long-term follow-up data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Birth sex: female 2. Desire for vaginal laser therapy for GSM 3. Age \>=18 years old 4. Willingness to forego other treatments for GSM within the study period 5. Diagnosed as postmenopausal (either by surgical removal of ovaries or natural progression defined as no periods in 1 year) Exclusion Criteria: 1. History of pelvic radiation 2. On hormone replacement therapy in the prior 3 months 3. Not able or willing to follow study instructions 4. Current diagnosis of recurrent UTIs
Where this trial is running
Irvine, California
- Beckman Laser Institute — Irvine, California, United States (RECRUITING)
Study contacts
- Principal investigator: Felicia Lane, MD — University of California, Irvine
- Study coordinator: Karla LORENTE, MD
- Email: klorente@hs.uci.edu
- Phone: 714-798-9044
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: Genitourinary Syndrome of Menopause