An Open-label, Long Term Extension Study of MT-8554 in Postmenopausal Women Experiencing Moderate to Severe Vasomotor Symptoms Who Completed Study MT-8554-A01
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 54
- 主要终点
- Percentage of Subjects With Adverse Events
研究概览
简要总结
An open-label, long term extension study of MT-8554 in postmenopausal women experiencing moderate to severe vasomotor symptoms who completed Study MT-8554-A01
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
- •Signed informed consent to participate in this study.
- •Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12.
排除标准
- •Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)
研究组 & 干预措施
Open Label
MT-8554
干预措施: MT-8554 (Drug)
结局指标
主要结局
Percentage of Subjects With Adverse Events
时间窗: 52 Weeks
Percentage of Subjects With Serious Adverse Events
时间窗: 52 Weeks
Percentage of Subjects With Clinical Laboratory Tests Abnormalities
时间窗: 52 Weeks
Hematology, biochemistry, coagulation and urinalysis
Change in Heart Rate
时间窗: Baseline and 52 Weeks
Change in Endometrial Thickness as Measured by Transvaginal Ultrasound
时间窗: Baseline and 52 Weeks
Change in ECG Parameters
时间窗: Baseline and 52 Weeks
PR, QRS, QT and QTc
Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy
时间窗: 52 Weeks
Change in Blood Pressure
时间窗: Baseline and 52 Weeks
Systolic and diastolic blood pressure
次要结局
- Change in Average Daily Frequency of Moderate to Severe VMS(Baseline and 52 Weeks)
- Change in Average Daily Severity Score of Mild to Severe VMS(Baseline and 52 Weeks)