Status:
RECRUITING
Laser Vaginal Treatment for GSM
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
Conditions:
Menopausal Urethral Atrophy
Vulvar Atrophy
Eligibility:
FEMALE
45-70 years
Phase:
NA
Brief 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 dr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04042766
Start Date
August 1 2019
End Date
March 1 2026
Last Update
February 15 2024
Active Locations (1)
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1
Sunnybrook Health Sciences Centre, University of Toronto
Toronto, Ontario, Canada, M4N 3M5