JPRN-jRCT2080221549未知2 期
A Phase II, multicenter, long-term extension study to compare the safety and efficacy of TAK-385 (10, 20, and 40 mg) following oral administration for 12 weeks or more in the treatment of endometriosis
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 397 人开始时间: 2011年8月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 397
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •Participants who have completed TAK-385/CCT-101 study
排除标准
- •1. Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug diffficult
- •2. Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings
- •3. Participants in whom investigator deems that the study drug shows no efficacy based on the level of pain, menstruation status, and the status of analgesic drug intake in TAK-385/CCT-101 study, or that study continuation represents an unacceptable risk
- •4. Participants in whom investigator deems that study continuation is difficult due to the occurrence of low estrogen symptoms in TAK-385/CCT-101 study which were attributed to the pharmacological effects of the study drug, taking into account the level and frequency of the adverse events etc. as well as the risk-benefit of subjects
研究者
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