A Multicenter Randomized Clinical Trial of Mifepristone Versus GnRHa for the Treatment of Adenomyosis
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24
研究概览
简要总结
The design was a prospective, randomized, positive-control, parallel-group, multicenter clinical trial. The study included a randomized, parallel-group treatment for 24 weeks in 140 subjects from eight hospitals in seven cities across the country who were diagnosed with Adenomyosis and associated symptoms (dysmenorrhea, with or without heavy menstrual flow) , the subjects were randomly assigned to the following two groups:
- Study Group: mifepristone tablets, 10 mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks;
- Control Group: dafinil (Triptorelin Acetate) , 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
mifepristone
mifepristone tablets，10mg，One tablet daily, oral treatment
干预措施: mifepristone (Drug)
Triptorelin Acetate
dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
干预措施: Triptorelin Acetate (Drug)
结局指标
主要结局
Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24
时间窗: Baseline and Week 24
The VAS is the most commonly used instrument assessing pain in clinical practice. It reflects the patient's subjective perception of pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). The last observation carry forward was used for missing data. Change=(Week 24 Score - Baseline Score)
次要结局
- Pictorial blood loss assessment chart（PBAC）(Baseline and week 24)
- Change from baseline in CA125 at week 24(Baseline and week 24)
- Change from baseline in hemoglobin at week 24(Baseline and week 24)
- Change from baseline in uterine size at week 24(Baseline and week 24)