Actively Recruiting
Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors
Led by University of Aarhus · Updated on 2024-12-05
60
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.
CONDITIONS
Official Title
Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Breast cancer survivor in endocrine therapy
- Symptomatic genitourinary syndrome of menopause with vaginal discomfort and/or pain during intercourse
- Able to read and understand Danish
- Able to give written informed consent
You will not qualify if you...
- Pelvic organ prolapse stage 2 or higher
- Use of non-hormonal vaginal therapies within 1 month prior to baseline
- Use of hormonal vaginal therapies within 12 months prior to baseline
- Use of chemotherapy within 6 months prior to baseline
- Acute urinary tract infection or active genital infection
- History of vaginal reconstructive surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Obstetrics and Gynaecology, Randers Regional Hospital
Randers, Denmark, 8930
Actively Recruiting
Research Team
S
Sine Jacobsen, MD
CONTACT
P
Pinar Bor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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