Vaginal Changes After CO2 Laser

What this trial studies

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.

Conditions in scope

• Genitourinary Syndrome of Menopause

Interventions

• Optical coherence tomography (OCT) (Diagnostic Test) — The OCT device with cover will be used to take measurements at four areas in the vaginal canal: the proximal posterior aspect, proximal anterior, distal anterior, and distal posterior. The proximal and distal points will be marked on the OCT…

Who can join

Women only · Ages 18 Years and up · Accepts healthy volunteers.

Inclusion criteria

• Birth sex: female
• Desire for vaginal laser therapy for GSM
• Age \>=18 years old
• Willingness to forego other treatments for GSM within the study period
• Diagnosed as postmenopausal (either by surgical removal of ovaries or natural progression defined as no periods in 1 year)

Exclusion criteria

• History of pelvic radiation
• On hormone replacement therapy in the prior 3 months
• Not able or willing to follow study instructions
• Current diagnosis of recurrent UTIs

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2023-05-01
• Primary completion: 2027-05-01
• Last update posted: 2026-02-18
• First posted: 2024-11-15

Sponsor & contact

Lead sponsor: University of California, Irvine (Other)

Collaborators: Alma Lasers, National Institute for Biomedical Imaging and Bioengineering (NIBIB)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Vaginal epithelial thickness (Measurements will be obtained once a month for the first three months. Measurements will be obtained at subsequent follow up visits every 3 months for 1 year.)
  OCT measurement of vaginal epithelial thickness
• Blood vessel density (Measurements will be obtained once a month for the first three months. Measurements will be obtained at follow up visits every 3 months for 1 year.)
  OCT measurement of blood vessel density

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.