Ulipristal Use in Chinese Population
关键词
抽象
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.
日期
| 最后验证: | 03/31/2020 |
| 首次提交: | 05/28/2016 |
| 提交的预估入学人数: | 06/30/2016 |
| 首次发布: | 07/06/2016 |
| 上次提交的更新: | 04/06/2020 |
| 最近更新发布: | 04/08/2020 |
| 实际学习开始日期: | 12/01/2015 |
| 预计主要完成日期: | 03/30/2020 |
| 预计完成日期: | 03/30/2020 |
状况或疾病
干预/治疗
Drug: Ulipristal
Other: Placebo
Drug: Ferrous sulphate
Drug: Tranexamic Acid
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 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. | Drug: Ulipristal Ulipristal acetate 5mg daily will be prescribed |
| Placebo Comparator: 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. | Other: Placebo Placebo pills will be prescribed |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Change of uterine bleeding [Through study completion, an average of 14weeks]
次要成果指标
1. Change of haemoglobin level [Through study completion, an average of 14weeks]
2. Change of fibroid volume [Through study completion, an average of 14weeks]
3. Intraoperative blood loss [After completion of 12 weeks course, the intraoperative blood loss at the time of performance of hysterectomy will be assessed.]
4. Conversion to less invasive intervention options [After completion of 12 weeks course of treatment and before the scheduled operation]
5. Side effects [Through study completion, an average of 14weeks]
6. Histology of the operative specimen [After completion of 12 weeks course of treatment]
