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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
190
MT-8554 Oral
Percentage of Subjects With Adverse Events
Time frame: 52 Weeks
Percentage of Subjects With Serious Adverse Events
Time frame: 52 Weeks
Percentage of Subjects With Clinical Laboratory Tests Abnormalities
Hematology, biochemistry, coagulation and urinalysis
Time frame: 52 Weeks
Change in Blood Pressure
Systolic and diastolic blood pressure
Time frame: Baseline and 52 Weeks
Change in Heart Rate
Time frame: Baseline and 52 Weeks
Change in ECG Parameters
PR, QRS, QT and QTc
Time frame: Baseline and 52 Weeks
Change in Endometrial Thickness as Measured by Transvaginal Ultrasound
Time frame: Baseline and 52 Weeks
Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy
Time frame: 52 Weeks
Change in Average Daily Frequency of Moderate to Severe VMS
Subjects were asked to record frequency and severity of VMS in an electronic diary. Severity levels are defined as follows. Mild : Sensation of heat without sweating Moderate : Sensation of heat with sweating, able to continue activity Severe : Sensation of heat with sweating, causing cessation of activity
Time frame: Baseline and 52 Weeks
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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
Clearwater, Florida, United States
Research Site
Crystal River, Florida, United States
...and 43 more locations
Change in Average Daily Severity Score of Mild to Severe VMS
Baseline VMS severity score : (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse) VMS severity score for a specific week during the open label treatment period :(1xFmi+2xFmo+3xFse)/(Fmi+Fmo+Fse) Fmi, Fmo, and Fse are the daily frequencies of mild, moderate, and severe VMS respectively. The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity).
Time frame: Baseline and 52 Weeks