Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Vasomotor Symptoms (VMS)

Intervention / Treatment
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* Drug: MT-8554


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent to participate in this study. Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12. Exclusion Criteria: Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>MT-8554 | Drug: MT-8554<br>* MT-8554 Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Adverse Events |  | 52 Weeks | 
| Percentage of Subjects With Serious Adverse Events |  | 52 Weeks | 
| Percentage of Subjects With Clinical Laboratory Tests Abnormalities | Hematology, biochemistry, coagulation and urinalysis | 52 Weeks | 
| Change in Blood Pressure | Systolic and diastolic blood pressure | Baseline and 52 Weeks | 
| Change in Heart Rate |  | Baseline and 52 Weeks | 
| Change in ECG Parameters | PR, QRS, QT and QTc | Baseline and 52 Weeks | 
| Change in Endometrial Thickness as Measured by Transvaginal Ultrasound |  | Baseline and 52 Weeks | 
| Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy |  | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 52 Weeks | 
| 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). | Baseline and 52 Weeks |