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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 397
- 主要终点
- Bone Mineral Density
研究概览
简要总结
The purpose of this study is to compare the long term safety and efficacy of TAK-385, once daily (QD) following continued administration in participants who completed a Phase II dose-finding study.
详细描述
This study is a long-term extension study for evaluation of the safety and efficacy of TAK-385 following administration for 24 weeks (calculated from Visit 3 in the TAK-385/CCT-101 study) in participants from the Phase II dose-finding study (TAK-385/CCT-101 study).
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants who have completed TAK-385/CCT-101 study
排除标准
- •Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult
- •Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings
- •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
- •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 participants.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
TAK-385 10 mg QD
干预措施: TAK-385 (Drug)
TAK-385 20 mg QD
干预措施: TAK-385 (Drug)
TAK-385 40 mg QD
干预措施: TAK-385 (Drug)
Leuplin
干预措施: Leuprorelin acetate (Drug)
结局指标
主要结局
Bone Mineral Density
时间窗: Up to Week 24.
Measured by Dual-energy X-ray absorptiometry (DXA)
Treatment-emergent Adverse Events
时间窗: Up to Week 16
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)
Vital Signs
时间窗: Up to Week 24
Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
Body Weight
时间窗: Up to Week 24
Electrocardiograms
时间窗: Up to Week 24.
Laboratory Values
时间窗: Up to Week 24
Serum NTx
时间窗: Up to Week 24
NTx is one of the biochemical bone metabolism markers
Serum BAP
时间窗: Up to Week 24
BAP is one of the biochemical bone metabolism markers
次要结局
- Visual Analogue Scale (VAS) Score for Pelvic Pain(Up to Week 24)
- VAS Score for Dyspareunia(Up to Week 24)