Laser treatment for vaginal symptoms in menopausal women
Laser Vaginal Treatment for GSM
This study is testing if laser treatment can help menopausal women aged 45-70 with vaginal dryness and discomfort feel better compared to standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | Female |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04042766 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of laser vaginal treatment for women suffering from Genitourinary Syndrome of Menopause (GSM), which is characterized by symptoms such as vaginal dryness, itching, and discomfort due to low estrogen levels. The study aims to enroll women aged 45-70 who have experienced moderate to severe vaginal symptoms for at least 30 days. Participants will receive laser therapy and will be monitored for improvements in their symptoms compared to standard treatments. The trial is designed as a randomized controlled trial to provide robust evidence on the efficacy of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are females aged 45-70 who have experienced moderate to severe vaginal symptoms related to GSM for at least 30 days.
Not a fit: Patients who are pregnant, lactating, or have acute vaginal infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for post-menopausal women suffering from GSM.
How similar studies have performed: While laser therapy for GSM is a relatively novel approach, preliminary studies have shown promising results in similar interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Females aged 45-70 years; 2. 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy); 3. 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; 4. no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it; 5. vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol. Exclusion Criteria: 1. Patient is pregnant/lactating 2. unexplained abnormal genital bleeding 3. current acute vaginal/ bladder infection 4. antibiotic use the past 30 days; 5. women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary; 6. concurrent use of any other new GSM treatment 7. pelvic surgery \<3 months 8. current treatment for chronic pelvic pain
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre, University of Toronto — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Patricia Lee, MD — Sunnybrook Health Sciences Centre
- Study coordinator: Razia Sultana, MD
- Email: razia.sultana@sri.utoronto.ca
- Phone: 4164806100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.