Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy

What this trial studies

We have recently developed and optimized a vaginal Optical Coherence tomography/angiography endoscopy imaging system. This technology is able to obtain a comprehensive image of the vaginal epithelium, blood vessels, and lamina propria. The primary focus of this study is establishing the Optical Coherence Tomography system's capability of capturing vaginal changes that occur before and after menopause, as well as before and after treatment with fractional-CO2 laser therapy. There are two aims of this study.

Conditions in scope

• Genitourinary Syndrome of Menopause

Interventions

• CO2 laser (Device) — Fractional CO2 vaginal laser for genitourinary syndrome of menopause
• OCT (Device) — Optical coherence tomography endoscope

Who can join

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

Inclusion criteria

• Aim 1:
• Women who are premenopausal, peri-menopausal and postmenopausal
• Aim 2:
• Postmenopausal women with genitourinary syndrome of menopause

Exclusion criteria

• history of pelvic irradiation
• Current pregnant or breastfeeding
• Use of hormone replacement therapy within three months of study enrollment
• Inability to read and understand english
• inability to follow research instructions

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: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2020-07-16
• Primary completion: 2026-07
• Last update posted: 2025-07-20
• First posted: 2021-02-04

Sponsor & contact

Lead sponsor: University of California, Irvine (Other)

Collaborators: National Institutes of Health (NIH)

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 (VET) (2 years)
  Vaginal epithelium thickness measured with the OCT.

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.