MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT03291067|
Recruitment Status : Completed
First Posted : September 25, 2017
Results First Posted : January 4, 2022
Last Update Posted : January 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Menopause Hot Flashes||Drug: MT-8554 1mg Drug: MT-8554 5mg Drug: MT-8554 10mg Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||375 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||October 9, 2017|
|Actual Primary Completion Date :||October 19, 2018|
|Actual Study Completion Date :||November 9, 2018|
|Experimental: MT-8554 1mg||
Drug: MT-8554 1mg
MT-8554 1mg QD, oral, 12 weeks
|Experimental: MT-8554 5mg||
Drug: MT-8554 5mg
MT-8554 5mg QD, oral, 12 weeks
|Experimental: MT-8554 10mg||
Drug: MT-8554 10mg
MT-8554 10mg QD, oral, 12 weeks
|Placebo Comparator: Placebo||
Placebo QD, oral, 12 weeks
- Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12 [ Time Frame: 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.
- Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12 [ Time Frame: 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.
- Percentage of Responders at Weeks 4 and 12 [ Time Frame: Week 4 and Week 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.
- Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12 [ Time Frame: Baseline, Weeks 4 and 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291067
|Study Director:||Head of Clinical Development,||Mitsubishi Tanabe Pharma Development America, Inc.|