LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breas… (NCT04081805) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)
Brazil195 participantsStarted 2019-09-30
Plain-language summary
This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic promestriene to treat symptoms of vulvovaginal atrophy of women treated for breast cancer.
Who can participate
Age range
30 Years – 75 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
. Women with breast cancer treated with surgery and / or chemotherapy and / or radiotherapy, that has been concluded at least 6 months before inclusion, whether or not using aromatase inhibitor and complaining of vulvovaginal atrophy
. To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of vulvovaginal atrophy:
. Absence of vaginal surgical procedure in the last year
. Genital prolapse stage no greater than stage II of Pelvic Organs Prolapse Quantitation (POP-Q) with Ba, Bp or C points less than or equal to 0
Exclusion criteria
. Active genital infection
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
Clinical Improvement of signs and symptoms of vulvovaginal atrophy with intravaginal LASER, Micro Ablative Radiofrequency, and topic promestriene
Timeframe: The evaluation will be done 90 days after treatment]
2
Satisfaction with treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic promestriene for women treated for breast cancer, with genitourinary atrophy syndrome
Timeframe: The evaluation will be done 90 days after treatment