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Study identifier: NCT06691178 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Vaginal Changes After CO2 Laser

Condition: Genitourinary Syndrome of Menopause  ·  Sponsor: University of California, Irvine

PhaseNA
Planned participants50
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersYes

About this study

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 w…

This description comes directly from the study's public registry record.

Talk to the study team

Karla LORENTE, MD  ·  714-798-9044  ·  klorente@hs.uci.edu

Nicole Wakida  ·  949.824.3295  ·  nwakida@hs.uci.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Beckman Laser InstituteIrvine, California, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06691178