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Laser Therapy
OCT Imaging + CO2 Laser Therapy for Genitourinary Syndrome
N/A
Recruiting
Led By Felicia Lane, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Postmenopausal women with genitourinary syndrome of menopause (Aim 2)
Premenopausal, peri-menopausal, and postmenopausal women (Aim 1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will use a new Imaging system to assess the changes in the vagina before and after menopause, and before and after treatment with fractional-CO2 laser therapy.
Who is the study for?
This trial is for premenopausal, peri-menopausal, and postmenopausal women to study vaginal health. For the second part of the study, only postmenopausal women with genitourinary syndrome can join. Women who've had pelvic radiation, are pregnant or breastfeeding, recently used hormone therapy, or can't follow instructions in English are excluded.Check my eligibility
What is being tested?
The trial is testing a new imaging system called Optical Coherence Tomography (OCT) endoscopy on vaginal tissues. It aims to detect changes due to menopause and observe how fractional-CO2 laser treatment affects these tissues over time.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort from the OCT endoscopy procedure and typical reactions associated with CO2 laser treatments such as redness, swelling or minor pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a postmenopausal woman experiencing vaginal dryness, itching, or pain.
Select...
I am a woman who has not gone through menopause.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Vaginal epithelial thickness (VET)
Secondary outcome measures
Lactobacillus abundance
Vaginal Health Index (VHI)
blood vessel density
Trial Design
2Treatment groups
Experimental Treatment
Group I: OCT onlyExperimental Treatment1 Intervention
Premenopausal, peri-menopausal and postmenopausal women who will only get one time OCT scan
Group II: CO2 Laser +OCTExperimental Treatment2 Interventions
Postmenopausal women with genitourinary syndrome of menopause who will receive CO2 vaginal laser treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CO2 laser
2016
Completed Phase 3
~150
OCT
2016
N/A
~1140
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
537 Previous Clinical Trials
1,921,550 Total Patients Enrolled
Felicia Lane, MDPrincipal Investigator - UC Irvine
St. Joseph Hospital, University of California-Irvine Medical Center
6 Previous Clinical Trials
339 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation treatment to my pelvic area.I am a postmenopausal woman experiencing vaginal dryness, itching, or pain.I have not used hormone replacement therapy in the last three months.I can follow all research instructions.I am a woman who has not gone through menopause.
Research Study Groups:
This trial has the following groups:- Group 1: CO2 Laser +OCT
- Group 2: OCT only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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