Menopausal Urethral AtrophyNCT04042766
Laser Vaginal Treatment for GSM
A study testing laser vaginal treatment in people with Menopausal Urethral Atrophy and Vulvar Atrophy, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral… Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Urethral Atrophy, Vulvar Atrophy
- What is being tested?
- laser vaginal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2019to 31 Oct 2027
- 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 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females aged 45-70 years;
- 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);
- at least 1 vaginal symptom reported from the following list, experienced for the past 30 days which is moderate or severe at least once a week: dryness | itching | irritation | soreness/pain | dyspareunia;
- no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;
- vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.
Who cannot join
- Patient is pregnant/lactating
- unexplained abnormal genital bleeding
- current acute vaginal/ bladder infection
- antibiotic use the past 30 days;
- women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary;
- concurrent use of any other new GSM treatment
- pelvic surgery <3 months
- current treatment for chronic pelvic pain
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centre, University of Toronto
Toronto, Ontario, M4N 3M5
About this study
Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.
- Conditions
- Menopausal Urethral Atrophy, Vulvar Atrophy
- Being tested
- laser vaginal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser vaginal treatmentProcedure or surgery
Er:YAG laser
| Study group | Role | What they receive |
|---|---|---|
| laser treatment | Active comparator | Not described Receives: Procedure: laser vaginal treatment |
| sham treatment | Sham comparator | Not described Receives: Procedure: laser vaginal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective measure of change in: the patient's most bothersome symptom
The most bothersome symptom of GSM (vaginal dryness, discomfort, itching, dyspareunia, urinary urgency, dysuria) will be identified and its severity rated on a standardized 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe
Measured: Baseline and 3 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Aug 2019
- Primary completion24 Mar 2025
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal Urethral AtrophyStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
- Responsible party
- Sponsor
- Investigators
- Patricia Lee, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042766
- Sponsor's protocol ID
- 094-2019
- Status last verified
- Apr 2026
- First submitted
- 31 Jul 2019
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Vaginal Treatment for GSM
- ClinicalTrials.gov ID
- NCT04042766
- Acronym / sponsor ID
- 094-2019
- Conditions
- Menopausal Urethral Atrophy, Vulvar Atrophy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 2 Aug 2019 (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.
Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser treatment | Active comparator | Procedure: laser vaginal treatment |
| sham treatment | Sham comparator | Procedure: laser vaginal treatment |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females aged 45-70 years;
- 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);
- at least 1 vaginal symptom reported from the following list, experienced for the past 30 days which is moderate or severe at least once a week: dryness | itching | irritation | soreness/pain | dyspareunia;
- no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;
- vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.
Key exclusion criteria (8 listed)
- Patient is pregnant/lactating
- unexplained abnormal genital bleeding
- current acute vaginal/ bladder infection
- antibiotic use the past 30 days;
- women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary;
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 |
|---|---|---|
| laser vaginal treatmentEr:YAG laser | Procedure or surgery | laser treatment, sham treatment |
Primary outcome
subjective measure of change in: the patient's most bothersome symptom
Time frame: Baseline and 3 months after treatment start
The most bothersome symptom of GSM (vaginal dryness, discomfort, itching, dyspareunia, urinary urgency, dysuria) will be identified and its severity rated on a standardized 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe
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 27 Apr 2026.
- Individual participant dataSharing planned: No
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.
Patricia Lee, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser vaginal treatment in people with Menopausal Urethral Atrophy and Vulvar Atrophy, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 5 inclusion and 8 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 27 Apr 2026. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
subjective measure of change in: the patient's most bothersome symptom (time frame: Baseline and 3 months after treatment start). 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 27 Apr 2026.