NCT01820728已完成3 期
A Phase III Clinical Study for the Comparison Evaluation of DA-3801 and Gonal-F® in Infertile Female Patients With Chronic Anovulation Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- The ovulation rate after 3 cycles of the injection
研究概览
简要总结
open label, active-controlled, randomized, parallel group, comparative study.
详细描述
This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene citrate treatment. The study is conducted with following methods: open label, active-controlled, randomized, parallel group, comparative.
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
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •WHO group II
- •Clomiphene citrate resistance
- •BMI: 17~29 kg/m^2
- •Irregular menstrual cycle
- •Normal blood concentration of FSH, E2, prolactin and TSH
排除标准
- •Uncontrolled endocrine disease
- •Ovarian cystic tumor which are NOT related to PCOS
- •Severe endometriosis
- •Chronic cardiovascular disease, liver complaint
研究组 & 干预措施
DA-3801 injection
Experimental
Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days
干预措施: DA-3801 Injection (Drug)
Gonal-F®
Active Comparator
75 IU/day is injected for 14 days
干预措施: Gonal-F® (Drug)
结局指标
主要结局
The ovulation rate after 3 cycles of the injection
时间窗: 5 weeks maximum
次要结局
- Total dose used, IU (International Unit)(5 weeks)
- Threshold dose, IU(5 weeks)
- Number of follicles(5 weeks)
- Duration of stimulation, days(5 weeks)
研究者
研究点 (1)
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