The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
375
MT-8554 1mg QD, oral, 12 weeks
MT-8554 5mg QD, oral, 12 weeks
MT-8554 10mg QD, oral, 12 weeks
Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at 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.
Time frame: Baseline, Weeks 4 and 12
Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at 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.
Time frame: Baseline, Weeks 4 and 12
Percentage of Responders at Weeks 4 and 12
Subjects with cutoff number or greater reduction in the average daily frequency of moderate and severe VMS compared to baseline. The cutoff number was calculated using anchor-based method. The cutoff number was defined as numerical value to maximize the sensitivity and the specificity, using Patient Global Impression of Change (PGIC) as the anchor.
Time frame: Week 4 and Week 12
Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12
The Insomnia Severity Index was a self-rated, 7-item validated sleep scale that measured clinical insomnia severity. The total score ranged from 0-28 where higher values indicated increased severity of insomnia.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo QD, oral, 12 weeks
Research Site
Birmingham, Alabama, United States
Research Site
Dothan, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Norwalk, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
Denver, Colorado, United States
Research Site
New London, Connecticut, United States
Research Site
New London, Connecticut, United States
Research Site
Aventura, Florida, United States
...and 53 more locations
Time frame: Baseline, Weeks 4 and 12