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NCT06691178 · ClinicalTrials.gov registry record · NA
Vaginal Changes After CO2 Laser
A NA study of Genitourinary Syndrome of Menopause, sponsored by University of California, Irvine.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06691178 is a NA study of Genitourinary Syndrome of Menopause that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 50 participants, below the 379-participant average among 6 other Genitourinary Syndrome of Menopause trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06691178, a NA study of Genitourinary Syndrome of Menopause, is actively recruiting participants, sponsored by University of California, Irvine.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Optical coherence tomography (OCT)
Study Locations (1)
California
- Beckman Laser Institute - Irvine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2027-07-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06691178
The ClinicalTrials.gov registry entry for NCT06691178 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 379-participant average among 6 other Genitourinary Syndrome of Menopause trials with a reported enrollment target (87% lower). The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Genitourinary Syndrome of Menopause appearing as the primary indexed condition, and to 1 intervention - of which Optical coherence tomography (OCT) is the first listed.
NCT06691178 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06691178 about?
NCT06691178 is a clinical study titled "Vaginal Changes After CO2 Laser". 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 fre...
What is the current status of trial NCT06691178?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2023-05-01. Estimated completion is 2027-07-01.
What conditions does trial NCT06691178 study?
This clinical trial studies the following conditions: Genitourinary Syndrome of Menopause.
What interventions are being tested in trial NCT06691178?
The interventions under investigation include: Optical coherence tomography (OCT) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06691178?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06691178 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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