Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Ar… (NCT05713435) | Clinical Trial Compass
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Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors
Belgium162 participantsStarted 2022-12-27
Plain-language summary
To study the efficacy and safety of intravaginal CO2 laser versus intravaginal Er:YAG laser and sham application in alleviating genitourinary symptoms in patients receiving an aromatase inhibitor as adjuvant treatment of breast cancer
Who can participate
Age range
18 Years – 100 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Recruited participants will meet all of these criteria:
* a history of breast cancer
* premenopausal at diagnosis of breast cancer
* using AI as an adjuvant treatment
* moderate to severe symptoms of GSM (VAS ≥ 4/10)
* currently menopausal, which can be either biochemical menopause as confirmed after chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of the trial)
Exclusion Criteria:
* Not willing to abstain from vaginal intercourse for 1 week following laser therapy
* Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion
* Use of hormonal therapy within 6 months prior to inclusion (systemic or local)
* Acute urinary or genital tract infections
* A history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree laceration
* Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System
* Previous vaginal mesh implantation
* Abnormal result in the last cervical smear (maximum 36 month before enrollment)
* Active cancer treatment (radiotherapy or chemotherapy) ongoing or planned prior to the measurement of the primary outcome (6 months after inclusion, 3 months after last laser)
* Vaginal stenosis that does not allow the placement of the laser probe
* Any condition that could interfere with study compliance
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in severity dryness as most bothersome symptom (MBS) of GSM at 3 months after the end of treatment