EUCTR2012-001465-33-PL进行中（未招募）不适用
A Phase III, multicentre, extension study investigating theefficacy and safety of repeated intermittent 3-month coursesof open-label administration of ulipristal acetate, in subjectswith symptomatic uterine myomas and heavy uterinebleeding. - PEARL extension 2
PregLem S.A.0 个研究点目标入组 90 人开始时间: 2012年7月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Provision of written informed consent prior to any study-related procedures.
- •2. Subject completed visit F – Follow-up of Pearl III extension study (PGL09-027) - without significant deviations.
- •3. Subject has no contra-indication to enter the long term extension study, based on the investigator’s judgment.
- •4. Females of childbearing potential are advised to practice a non-hormonal method of contraception among one of the following:
- •a. Sexual abstinence
- •b. Diaphragms
- •c. Condom or having a partner with a vasectomy with either confirmed azoospermia or performed at least 6 months prior to the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. 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.
- •2. Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol: progestins (systemic or progestin releasing intra-uterine system), oestrogens, GnRH-Agonists/Antagonists, hormonal contraceptives, systemic glucocorticoids (oral and injectable), and/or treatments with potent inhibitors or inducers of CYP3A4. Wash-out periods prior to Visit I are as follows:
- •a. Progestins and Oestrogens: 1 month
- •b. GnRH-Agonists/Antagonists: 3 months
- •c. Systemic glucocorticoids: 1 month (3 months after depot injections)
- •d. CYP3A4 inhibitors or inducers: 2 weeks
- •3. Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study.
- •4. Subject has a current problem with alcohol or drug abuse.
- •5. Subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- •6. 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.
研究者
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