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
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- 入组人数
- 397
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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