Genitourinary Syndrome of MenopauseNCT04737616
Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy
A study testing CO2 laser and OCT in people with Genitourinary Syndrome of Menopause, run by University of California, Irvine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- CO2 laser and OCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aim 1:
- . Women who are premenopausal, peri-menopausal and postmenopausal
- Aim 2:
- . Postmenopausal women with genitourinary syndrome of menopause
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute and Medical Clinic
Irvine, California, 92612
About this study
Official title: Continuous Monitoring and Management of Vaginal Health Via Multifunctional 1.7um Optical Coherence Tomography/Angiography Endoscopy
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.
Read more
Aim 1:
- To determine the feasibility and sensitivity of the integrated optical coherence endoscope to assess vaginal tissue integrity in pre, peri and postmenopausal women.
Aim 2:
To optically visualize the effects of fractional-CO2 laser treatment on vaginal tissue over the course of C02 vaginal laser therapy.
Read the detailed description
The 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.
Aim 1: To determine the feasibility and sensitivity of the integrated optical coherence endoscope to assess vaginal tissue integrity in pre, peri and postmenopausal women
We will enroll up to 90 women (age: 18 and older) who will be classified as pre-menopausal, peri- menopausal, or post-menopausal. There will be 30 women in each group. All enrolled subjects will first complete informed consents.
They will then fill out a questionnaire (the vulvovaginal symptom questionnaire) about their vaginal health. This will be followed by a pelvic exam to determine the vaginal health (vaginal health index) and to obtain a vaginal swab for assessment of the vaginal microbiome .
This will be followed by OCT scan of the vaginal tissue. There will be only one visit.
Aim 2: To optically visualize the effects of fractional-CO2 laser treatment on vaginal tissue over the course of C02 vaginal laser therapy.
Up to thirty Post-menopausal subjects with GSM who desire fractional-CO2 laser therapy, will be recruited.
Each visit will include: completion of a questionnaire (the vulvovaginal symptom questionnaire) about their vaginal health; followed by a pelvic exam to determine the vaginal health (vaginal health index) and to obtain a vaginal swab for assessment of the vaginal microbiome and an OCT scan of the vaginal tissue before the CO2 vaginal laser treatment.
This group will have a total of three visits with CO2 laser treatments. There will be a fourth visit which will include all the above study procedures except the CO2 laser treatment.
Subjects who complete 3 laser treatments will be offered participation in long term follow up with repeat OCT imaging every 3 months at 3, 6, 9 and 12 months after the final laser treatment to study the long- term effects of the laser treatment on the vaginal tissue.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- CO2 laser, OCT
- Keywords
- OCT: Optical coherence tomography, CO2: Carbon dioxide, GSM: genitourinary syndrome of menopause, OCE: Optical coherence angiography, OCTA:Optical coherence tomography with angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 laserDevice
Fractional CO2 vaginal laser for genitourinary syndrome of menopause
OCTDevice
Optical coherence tomography endoscope
| Study group | Role | What they receive |
|---|---|---|
| CO2 Laser +OCT | Experimental | Postmenopausal women with genitourinary syndrome of menopause who will receive CO2 vaginal laser treatment Receives: Device: CO2 laser; Device: OCT |
| OCT only | Experimental | Premenopausal, peri-menopausal and postmenopausal women who will only get one time OCT scan Receives: Device: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal epithelial thickness (VET)
Vaginal epithelium thickness measured with the OCT.
Measured: 2 years
Secondary outcomes (3)
blood vessel density
The blood vessel density will be measured by OCT
Measured: 2 years
Vaginal Health Index (VHI)
VHI to be measured on exam
Measured: 2 years
Lactobacillus abundance
Lactobacillus abundance by RNA sequencing
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start16 Jul 2020
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of MenopauseStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Felicia Lane, University of California, Irvine
- Investigators
- Felicia Lane, MD, Principal investigator, UC Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737616
- Sponsor's protocol ID
- 20195446
- Status last verified
- Jun 2025
- First submitted
- 22 Jan 2021
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring and Management of Vaginal Health Via Multifunctional 1.7um Optical Coherence Tomography/Angiography Endoscopy
- ClinicalTrials.gov ID
- NCT04737616
- Acronym / sponsor ID
- 20195446
- Conditions
- Genitourinary Syndrome of Menopause
- Keywords
- OCT: Optical coherence tomography, CO2: Carbon dioxide, GSM: genitourinary syndrome of menopause, OCE: Optical coherence angiography, OCTA:Optical coherence tomography with angiography
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Aim 1:
- To determine the feasibility and sensitivity of the integrated optical coherence endoscope to assess vaginal tissue integrity in pre, peri and postmenopausal women.
Aim 2:
To optically visualize the effects of fractional-CO2 laser treatment on vaginal tissue over the course of C02 vaginal laser therapy.
Detailed description
The 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.
Aim 1: To determine the feasibility and sensitivity of the integrated optical coherence endoscope to assess vaginal tissue integrity in pre, peri and postmenopausal women
We will enroll up to 90 women (age: 18 and older) who will be classified as pre-menopausal, peri- menopausal, or post-menopausal. There will be 30 women in each group. All enrolled subjects will first complete informed consents.
They will then fill out a questionnaire (the vulvovaginal symptom questionnaire) about their vaginal health. This will be followed by a pelvic exam to determine the vaginal health (vaginal health index) and to obtain a vaginal swab for assessment of the vaginal microbiome .
This will be followed by OCT scan of the vaginal tissue. There will be only one visit.
Aim 2: To optically visualize the effects of fractional-CO2 laser treatment on vaginal tissue over the course of C02 vaginal laser therapy.
Up to thirty Post-menopausal subjects with GSM who desire fractional-CO2 laser therapy, will be recruited.
Each visit will include: completion of a questionnaire (the vulvovaginal symptom questionnaire) about their vaginal health; followed by a pelvic exam to determine the vaginal health (vaginal health index) and to obtain a vaginal swab for assessment of the vaginal microbiome and an OCT scan of the vaginal tissue before the CO2 vaginal laser treatment.
This group will have a total of three visits with CO2 laser treatments. There will be a fourth visit which will include all the above study procedures except the CO2 laser treatment.
Subjects who complete 3 laser treatments will be offered participation in long term follow up with repeat OCT imaging every 3 months at 3, 6, 9 and 12 months after the final laser treatment to study the long- term effects of the laser treatment on the vaginal tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 Laser +OCT | Experimental | Device: CO2 laser, Device: OCTPostmenopausal women with genitourinary syndrome of menopause who will receive CO2 vaginal laser treatment |
| OCT only | Experimental | Device: OCTPremenopausal, peri-menopausal and postmenopausal women who will only get one time OCT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- . Women who are premenopausal, peri-menopausal and postmenopausal
- . Postmenopausal women with genitourinary syndrome of menopause
Key exclusion criteria (5 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 laserFractional CO2 vaginal laser for genitourinary syndrome of menopause | Device | CO2 Laser +OCT |
| OCTOptical coherence tomography endoscope | Device | CO2 Laser +OCT, OCT only |
Primary outcome
Vaginal epithelial thickness (VET)
Time frame: 2 years
Vaginal epithelium thickness measured with the OCT.
3 secondary outcomes
blood vessel density
Time frame: 2 years
Vaginal Health Index (VHI)
Time frame: 2 years
Lactobacillus abundance
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felicia Lane, MD principal investigator
UC Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 laser and OCT in people with Genitourinary Syndrome of Menopause, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal epithelial thickness (VET) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.