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Clinical Trials in Denmark / NCT06007027
Recruiting Not applicable

Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

NCT06007027 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Not applicable
Started
2024-12-01
Last updated
2024-12-05

Condition(s) studied

Genitourinary Syndrome of Menopause

Investigational drug(s) / intervention(s)

SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy

SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy: The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Vaginal dryness — Symptom data is collected at baseline visit and one month after the last treatment
    Participant are asked to complete the 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse vaginal dryness.

Trial sites (1)

FacilityCityRegionStatus
Department of Obstetrics and Gynaecology, Randers Regional Hospital Randers Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06007027 on ClinicalTrials.gov ↗ ← All trials in Denmark