A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety, Pharmacokinetics and Efficacy of Intravenous Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labour
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Cervical ripening
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.
详细描述
A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A dose-escalation portion of the study is followed by a randomized, double-blind, placebo-controlled portion of the study. The endpoints include cervical ripening, as well as progression to labor and delivery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 40 years
- •Normal pregnancy
- •At least 40 weeks of gestation
- •Otherwise healthy
排除标准
- •Anemia or hypertension
- •Presence of chronic disease
- •Endometriosis
- •Known fetal anomaly
- •Substance abuse
- •History of cancer
研究组 & 干预措施
7.5 µg/kg/d
Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A.
干预措施: Serelaxin (Drug)
25 µg/kg/d
Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A.
干预措施: Serelaxin (Drug)
75 µg/kg/d
Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B.
干预措施: Serelaxin (Drug)
Placebo
Participants who received IV infusion of placebo, some during part A and others during part B.
干预措施: Placebo (Drug)
结局指标
主要结局
Cervical ripening
时间窗: Through 24 hours
次要结局
- Progression to active labor and delivery(Within 7 Days of Drug Infusion)