Genitourinary Syndrome of Menopause study: SmartXIDE2V2LR
Official title Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors
ClinicalTrials.gov ID: NCT06007027
What this study is testing
- What it's testing
- The study will see if the laser improves symptoms and changes vaginal health in breast cancer survivors. It will compare active laser to a placebo and follow up for a year.
- Who it's for
- Breast cancer survivors who have menopause‑related genitourinary problems.
- What's involved
- Participants will receive 3–5 laser treatments every 3 weeks, or a placebo laser. They will fill out questionnaires, have vaginal fluid tests, biopsies, and microbiome checks before and after each treatment.
- Time commitment
- The study lasts about one year, with 3–5 laser sessions spaced 3 weeks apart and regular follow‑up visits for tests and questionnaires.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100, women only
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Randers, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Randers, Denmark. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.