Laser Treatment of Genito-urinary Syndrome in Women (NCT03238053) | Clinical Trial Compass
WithdrawnNot Applicable
Laser Treatment of Genito-urinary Syndrome in Women
Stopped: Hospital terminated treatment with laser
Denmark0Started 2022-10-01
Plain-language summary
Women with genitourinary syndrome of menopause, overactive bladder, with breast or endometrial cancer are randomized to either laser treatment og sham treatment for 3 months. The randomization is stratified for estrogen treatment. The effect is evaluated by questionnaire, histology and microbiology swaps
Who can participate
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:
* menopause i.e. age more than 50 years and absence of menstruation for twelve months
* breast cancer
* endometrial cancer
* symptoms of vaginal dryness
* dyspareunia rated as moderate or severe most bothersome symptoms
Exclusion Criteria:
* use of vaginal moisturizers, lubricants or any other local preparation within the thirty days prior to inclusion
* acute or recurrent urinary tract infections
* active genital infections i.e. herpes genitalis, candida
* previous reconstructive pelvic surgery
* pelvis organ prolapse stage 2
* any serious disease or chronic condition that could interfere with study compliance except from breast and endometrial cancer
* psychiatric disorders precluding informed consent
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.