Ulipristal Use in Chinese Population
Fibroid
About this trial
This is an interventional treatment trial for Fibroid focused on measuring Fibroid, Ulipristal, Selective progesterone receptor modulator, Chinese
Eligibility Criteria
Inclusion Criteria:
- Scheduled for hysterectomy for symptomatic fibroid
- Be a Chinese
- Pre-menopausal
- With a Pictorial bleeding assessment chart score > 100 during menstruation at the preceding month
- Non-pregnant
- With a body-mass index between 18 to 30.
Exclusion Criteria:
- History of uterine surgery (apart from Caesarean section or cervical conization), endometrial ablation or uterine artery embolization
- History of gynaecological malignancies
- History of endometrial hyperplasia
- Known haemoglobinopathy (e.g. thalassaemia)
- Known severe coagulation disorder
- Has one or more ovarian cysts >= 4 cm in diameter diagnosed by ultrasound
- History of use of Selective Progesterone Receptor Modulator (SPRM)
- Current (within 12 months) problem with alcohol or drug abuse.
- Known allergy to SPRM or ferrous sulphate
Sites / Locations
- Department of Obstetrics and Gynaecology, Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ulipristal
Placebo
Patients will be prescribed Ulipristal acetate 5mg daily for 12 weeks before operation. If the patients have anaemia with haemoglobin less than 10g/dL, ferrous sulphate 300mg three times a day will be prescribed as well. Tranexamic Acid 500mg four times a day will be prescribed on request basis.
Patients will be prescribed placebo pills daily for 12 weeks before operation. If the patients have anaemia with haemoglobin less than 10g/dL, ferrous sulphate 300mg three times a day will be prescribed as well. Tranexamic Acid 500mg four times a day will be prescribed on request basis.