This study evaluates the effectiveness and safety of ulipristal acetae (UPA) in women with symptomatic uterine fibroids. Those who fulfilled inclusion/exclusion criteria will be treated UPA at daily dose of 5mg.
Who can participate
Age range
18 Years – 48 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 aged 18-48
* Regular cycle of 22-35 days interval and FSH \<=20 mUI/mL.
* \>=1 uterine fibroid of 3\<= d \< 10cm (regardless of location), diagnosed by transvaginal ultrasound.
* Heavy menstrual bleeding (blood loss \>80ml/cycle).
* Uterine size \< 16 weeks of GA on clinical examination.
* Agree to participate in the study.
Exclusion Criteria:
* Previous or current treatment of uterus, cervix, ovarian or breast cancer.
* Previous endometrial ablation or uterine artery embolization.
* Abnormal PAP's smear result within 12 months prior to recruitment.
* Endometrial hyperplasia within 6 months prior to recruitment.
* Uterine polyp \>2cm.
* Ovarian cysts 4cm diagnosed by transvaginal ultrasound.
* Severe anemia (Hb 6 g/dl) or indication for blood transfusion.
* Coagulation disorder indicated for treatment.
* Increased liver enzyme level of twofold or more than normal upper limit.
* Previous use of SPRM.
* Treatment of systemic progestin or intrauterine device or hormonal contraception within 2 months, or use of GnRH analogue within 5 months prior to recruitment.
* Current use of acetylsalicylic acid, mefenamic acid, anticoagulation agents, antifibrinolysis agents, or systemic corticoid
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
Amenorrhea
Timeframe: from first dose to the end of 3 consecutive months of treatment course