Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change of uterine bleeding
研究概览
简要总结
Uterine leiomyomas is the commonest benign tumour of the female genital tract. It lead to menorrhagia, anaemia, pain and pressure symptoms. Due to the enlarged uterus, the use of minimal invasive surgery is limited. There is also increase risk of intraoperative blood transfusion. Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM). Preoperative use of Ulipristal for 12 weeks has been shown to decrease uterine bleeding, fibroid volume, pre-operative anaemia and symptoms severity. However there is still lacking evidence in terms of long term safety and efficacy, especially in Chinese population. The aim of the present study is to evaluate the effect and safety on preoperative use of Ulipristal on fibroid.
详细描述
Uterine leiomyomas is the commonest benign tumour of the female genital tract. It is often asymptomatic, but can also lead to anaemia, pain and pressure symptoms. It is the commonest indication for hysterectomy, especially abdominal hysterectomy. Currently, the use of hormonal treatment is associated with side effects including gastrointestinal upset, bloating, weight gain and thromboembolic risks. The main stay for treatment relies on surgery.
Furthermore, the use of minimal invasive surgeries is limited by the size of the fibroids. Preoperative use of Gonadotrophic Releasing Hormone analogues (GnRHa) is effective in shrinkage of the uterine leiomyomas and reduction of uterine bleeding. However, postmenopausal symptoms including hot flushes, vaginal dryness are profound.
Ulipristal acetate (UPA), previously named CDB-2914, is a selective progesterone-receptor modulator (SPRM). It binds to the progesterone receptors with high affinity. It inhibits follicular development and ovulation, while it has no significant effects on estradiol levels and antiglucocorticoid activity. Preoperative use of Ulipristal for symptomatic uterine fibroids has been investigated in randomized controlled study with improvement in terms of uterine bleeding, fibroids volume, pre-operative anaemia and symptoms severity. However there is still lacking evidence in terms of long term safety and efficacy. Also there is lack of evidence in Chinese population.
The aim of the present study is to evaluate the effect and safety on preoperative use of Ulipristal on fibroid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Ulipristal
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.
干预措施: Ulipristal acetate (Drug)
Ulipristal
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.
干预措施: Ferrous sulphate (Drug)
Ulipristal
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.
干预措施: Tranexamic Acid (Drug)
Placebo
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.
干预措施: Placebo pills (Other)
Placebo
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.
干预措施: Ferrous sulphate (Drug)
Placebo
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.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Change of uterine bleeding
时间窗: Through study completion, an average of 14weeks
Pictorial bleeding assessment chart will be used for assessment of uterine bleeding. Patients will be assessed before the start of treatment, after completion of 6 weeks course and after completion of 12 weeks course. The change of uterine bleeding after completion of 12 weeks course of treatment will be recorded.
次要结局
- Change of haemoglobin level(Through study completion, an average of 14weeks)
- Change of fibroid volume(Through study completion, an average of 14weeks)
- Intraoperative blood loss(After completion of 12 weeks course, the intraoperative blood loss at the time of performance of hysterectomy will be assessed.)
- Conversion to less invasive intervention options(After completion of 12 weeks course of treatment and before the scheduled operation)
- Side effects(Through study completion, an average of 14weeks)
- Histology of the operative specimen(After completion of 12 weeks course of treatment)
研究者
Lui Man Wa
Dr
Queen Mary Hospital, Hong Kong