Status:
RECRUITING
Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors
Lead Sponsor:
University of Aarhus
Conditions:
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
18-100 years
Phase:
NA
Brief Summary
This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatm...
Eligibility Criteria
Inclusion
- Breast cancer survivor in endocrine therapy
- Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia
- Able to read and understand Danish
- Able to give written informed consent
Exclusion
- Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system
- Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively)
- Use of Chemotherapy (6 months prior to the baseline visit)
- Acute urinary tract infection or active genital infection
- History of vaginal reconstructive surgery
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06007027
Start Date
December 1 2024
End Date
March 30 2026
Last Update
December 5 2024
Active Locations (1)
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1
Department of Obstetrics and Gynaecology, Randers Regional Hospital
Randers, Denmark, 8930