A Phase III, Multicentre, Extension Study Investigating the Efficacy and Safety of Repeated Intermittent 3-month Courses of Open-label Administration of Ulipristal Acetate, in Subjects With Symptomatic Uterine 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
- 64
- 试验地点
- 16
- 主要终点
- Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
研究概览
简要总结
This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024).
This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) - without significant deviations.
- •Females of childbearing potential are advised to practice a non-hormonal method of contraception.
排除标准
- •Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments.
- •Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol.
- •Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study.
- •Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.
研究组 & 干预措施
Ulipristal Acetate (PGL4001) 10mg
Ulipristal Acetate (PGL4001)10mg daily administration
干预措施: Ulipristal Acetate - open label (Drug)
结局指标
主要结局
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
时间窗: 18 months
Average score of the first 3 questions.
次要结局
未报告次要终点