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RECRUITING
NCT06007027
NA

Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

Sponsor: University of Aarhus

View on ClinicalTrials.gov

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.

Official title: Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study

Key Details

Gender

FEMALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-12-01

Completion Date

2026-03-30

Last Updated

2024-12-05

Healthy Volunteers

No

Interventions

DEVICE

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The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.

Locations (1)

Department of Obstetrics and Gynaecology, Randers Regional Hospital

Randers, Denmark