| NCT ID | NCT06691178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Irvine |
| Condition | Genitourinary Syndrome of Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-05-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Genitourinary syndrome of menopause (GSM) occurs due to a decline in estrogen levels as a woman approaches menopause. The syndrome negatively impacts women's quality of life and is characterized by vaginal dryness, burning, diminished lubrication, painful intercourse and urinary symptoms such as frequency and urgency. GSM is diagnosed by symptom assessment and physical exam, with current mainstay of treatment being vaginal estrogen. Women with a history of breast cancer, gynecologic cancer, or venous thromboembolism may not be candidates for hormonal therapy. Thus, there has been a quest for effective non-hormonal forms of treatment for GSM. The use of vaginal CO2 laser treatment for GSM has shown promising results. In this study, we aim to use long-wavelength optical coherence tomography/angiography/elastography (OCT/OCTA/OCE) to document changes that occur in the vaginal epithelium during menopause as well as after treatment for GSM. OCT is a well-studied technology and is widely used in Dermatology and Ophthalmology. In collaboration with the Beckman Laser Institute (BLI), we have developed a non-invasive vaginal probe (HS# 2017-3686). The probe has subsequently been used in previous studies to validate measurements in the vaginal epithelium (HS# 2019-5446). A previous RCT compared clinical response to laser therapy to a control group that received a low level of laser therapy. The study also did not examine histology. This will be a randomized controlled trial in which women will be enrolled into one group receiving laser therapy and compared to a true sham group that will not receive laser therapy at all. Response will be measured primarily by OCT device as well as optional vaginal biopsies. There will also be questionnaires and exam of the vaginal tissue using the VHI.
Eligibility 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
Contact & Investigator
Felicia Lane, MD
PRINCIPAL INVESTIGATOR
University of California, Irvine
Frequently Asked Questions
Who can join the NCT06691178 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Genitourinary Syndrome of Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06691178 currently recruiting?
Yes, NCT06691178 is actively recruiting participants. Contact the research team at klorente@hs.uci.edu for enrollment information.
Where is the NCT06691178 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT06691178 clinical trial?
NCT06691178 is sponsored by University of California, Irvine. The principal investigator is Felicia Lane, MD at University of California, Irvine. The trial plans to enroll 50 participants.