NCT06007027 Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors
| NCT ID | NCT06007027 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Genitourinary Syndrome of Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-12-01 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06007027 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Genitourinary Syndrome of Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06007027 currently recruiting?
Yes, NCT06007027 is actively recruiting participants. Contact the research team at sinjac@rm.dk for enrollment information.
Where is the NCT06007027 trial being conducted?
This trial is being conducted at Randers, Denmark.
Who is sponsoring the NCT06007027 clinical trial?
NCT06007027 is sponsored by University of Aarhus. The trial plans to enroll 60 participants.