Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological C… (NCT03372720) | Clinical Trial Compass
CompletedNot Applicable
Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors
United States19 participantsStarted 2018-05-11
Plain-language summary
This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers.
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:
* Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment \>= 6 months prior to enrollment
* Any form of hysterectomy, including radical hysterectomy permitted
* Must have no evidence of recurrent disease on pelvic exam within past 3 months
* Radiation therapy is permitted but not required
* Patient reported dyspareunia and/or vaginal dryness with severity of \>= 4 on a scale from 0 (none) to 10 (most severe) that has been persistent over \>= 4 weeks and/or the inability to be sexually active due to pain
Exclusion Criteria:
* Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer
* Pelvic organ prolapse stage II or higher
* Prior reconstructive pelvic surgery involving mesh
* Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to enrollment
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 genitourinary syndrome of menopause (GSM) symptoms
Timeframe: Baseline to 12 weeks
Trial details
NCT IDNCT03372720
SponsorOhio State University Comprehensive Cancer Center