A Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of MT-8554 on the Frequency and Severity of Vasomotor Symptoms in Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 63
- 主要终点
- Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.
详细描述
This is a Phase II randomized, double-blind, placebo-controlled study for dose selection in postmenopausal women with moderate to severe VMS, defined as follows:
- Moderate: sensation of heat with sweating, able to continue activity
- Severe: sensation of heat with sweating, causing cessation of activity This study is comprised of a screening period, a run-in period and a 12-week double-blind treatment period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Additional screening criteria check may apply for qualification:
- •Provide written informed consent to participate in this study
- •Spontaneous amenorrhea for ≥12 months; or spontaneous amenorrhea for at least 6 months and with follicle stimulating hormone (FSH) levels >40 mIU/mL; or documented bilateral salpingo oophorectomy ≥6 weeks, with or without hysterectomy
- •7 or more moderate to severe VMS per day, or 50 or more moderate to severe VMS per week
- •Have a consistent bedtime on at least 5 nights per week
- •Mean VMS frequency during the Placebo Run in period does not drop by more than 50% from the mean level reported for 2 weeks during the Screening period
- •VMS diary compliance >50%
- •In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements
排除标准
- •Additional screening criteria check may apply for qualification:
- •History of any cancer within 5 years except for basal cell carcinoma
- •History of undiagnosed abnormal vaginal bleeding
- •History of Hepatitis B, Hepatitis C or HIV
- •History of psychiatric illness, excessive alcohol intake or use of recreational drugs who are unsuitable for study enrollment and compliance
- •Presence or history of severe adverse reaction or allergy to any drug
- •Peripheral vascular disease or disorders with associated vasculopathies
- •Clinically significant conditions which could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator
- •Endometrial thickness of >=5 mm as measured by transvaginal ultrasound
- •Abnormal result from baseline endometrial biopsy (i.e., endometrial hyperplasia or endometrial cancer)
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin ≥2.0 × upper limit of normal (ULN) above the reference range
- •Subjects of childbearing potential
研究组 & 干预措施
MT-8554 1mg
干预措施: MT-8554 1mg (Drug)
MT-8554 5mg
干预措施: MT-8554 5mg (Drug)
MT-8554 10mg
干预措施: MT-8554 10mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12
时间窗: Baseline, Weeks 4 and 12
The daily severity score of VMS was defined as (2xFmo + 3xFse)/(Fmo + Fse) for baseline, and (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse) for Weeks 4 and 12, where Fmi, Fmo, and Fse were the daily frequencies of mild, moderate, and severe VMS, respectively. The average daily severity score of mild to severe VMS at a time point (Baseline, Week 4 and Week 12) was the average of the daily severity of available diary days in the corresponding 7-day window. The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity). Change in the average daily severity score of mild to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.
Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12
时间窗: Baseline, Weeks 4 and 12
The average daily frequency of moderate to severe VMS at a time point (Baseline, Weeks 4 and 12) was the average of the frequency of moderate to severe VMS of available diary days in a 7-day window. Changes in the average daily frequency of moderate to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.
次要结局
- Percentage of Responders at Weeks 4 and 12(Week 4 and Week 12)
- Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12(Baseline, Weeks 4 and 12)