A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- PregLem SA
- 入组人数
- 132
- 试验地点
- 15
- 主要终点
- percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received
研究概览
简要总结
This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment.
This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.
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 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.
排除标准
- •Subject has a large uterine polyp (> 2cm).
- •Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.
- •Subject has abnormal hepatic function at re-test.
- •Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.
- •Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.
研究组 & 干预措施
A
PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ended by a drug free period until return of menses.
干预措施: PGL4001, placebo, drug free period (Drug)
B
PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets) during 3 periods each ended by a drug free period until return of menses.
干预措施: PGL4001, progestin, drug free period (Drug)
结局指标
主要结局
percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received
时间窗: From baseline to end of each PGL4001 treatment (3months treatment)
次要结局
未报告次要终点