UA Versus UAE in Treatment of Fibroids (NCT04832906) | Clinical Trial Compass
CompletedPhase 4
UA Versus UAE in Treatment of Fibroids
Egypt70 participantsStarted 2019-03-13
Plain-language summary
Study objective: To prove that Ulipristal acetate is an effective line of management for uterine fibroids by causing a significant decline in fibroid volumes resulting in a substantial relief of fibroid-related symptoms, and to compare its results with those of uterine artery embolization.
Design: A randomized control trial. Setting: Maternity Hospital, Ain Shams University.
Patients: Women with symptomatic uterine fibroids.
Interventions: 70 women were randomly assigned to either Ulipristal Acetate (UA) group or uterine artery embolization (UAE) group (35 in each group). Both groups were followed up to detect the decline in fibroid size as well as the improvement of symptoms.
Who can participate
Age range
35 Years – 50 Years
Sex
ALL
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:
* Their age should range from 35 to 50 years.
* Their body mass index (BMI) should range from 18 to 35 Kg/m2.
* The presence of one or more symptomatic type 2, 3, 4, 5, or 6 uterine fibroids according to the FIGO classification.
* The dominant fibroid diameter should range from 4 to 8 cm as assessed by ultrasound.
* They should not be seeking future fertility.
* They should be refusing any surgical intervention whether myomectomy or hysterectomy.
Exclusion Criteria:
* Post-menopausal status or premature ovarian failure.
* Type 0, 1 and 7 uterine fibroids according to FIGO classification.
* Previous myomectomy or any uterine surgery.
* Previous or ongoing hormonal treatment.
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
Decline in dominant fibroid volume (in cubic centimeters).