Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

What this trial studies

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.

Conditions in scope

• Genitourinary Syndrome of Menopause

Interventions

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DEKA, Florence, Italy (Device) — The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.

Who can join

Women only · Ages 18 Years to 100 Years

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-12-01
• Primary completion: 2026-01-30
• Last update posted: 2024-12-05
• First posted: 2023-08-23

Sponsor & contact

Lead sponsor: University of Aarhus (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• 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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.