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

Vasomotor Symptoms (VMS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541200
• Other study ID #: MT-8554-A02
• Status: Completed
• Phase: Phase 2
• Start date: April 18, 2018
• Est. completion date: November 15, 2019

Study information

• Verified date: May 2023
• Source: Mitsubishi Tanabe Pharma America Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Vasomotor Symptoms (VMS)

Intervention

Drug:
• MT-8554
MT-8554 Oral

Locations

Country	Name	City	State
United States	Research Site	Baltimore	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bristol	Tennessee
United States	Research Site	Clearwater	Florida
United States	Research Site	Cleveland	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Crystal River	Florida
United States	Research Site	Denver	Colorado
United States	Research Site	Dothan	Alabama
United States	Research Site	Draper	Utah
United States	Research Site	Englewood	Ohio
United States	Research Site	Fort Myers	Florida
United States	Research Site	Fort Worth	Texas
United States	Research Site	Hialeah	Florida
United States	Research Site	Hialeah	Florida
United States	Research Site	Hutchinson	Kansas
United States	Research Site	Idaho Falls	Idaho
United States	Research Site	Jackson	Tennessee
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jupiter	Florida
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Kansas City	Missouri
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lawrenceville	New Jersey
United States	Research Site	Marrero	Louisiana
United States	Research Site	Memphis	Tennessee
United States	Research Site	Metairie	Louisiana
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Missoula	Montana
United States	Research Site	Morehead City	North Carolina
United States	Research Site	New London	Connecticut
United States	Research Site	Norfolk	Virginia
United States	Research Site	Norwalk	California
United States	Research Site	Orlando	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Ponte Vedra	Florida
United States	Research Site	Port Saint Lucie	Florida
United States	Research Site	Sacramento	California
United States	Research Site	Saginaw	Michigan
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Diego	California
United States	Research Site	Sandy Springs	Georgia
United States	Research Site	Sarasota	Florida
United States	Research Site	Schertz	Texas
United States	Research Site	Seattle	Washington
United States	Research Site	Wellington	Florida
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wichita	Kansas
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma America Inc.

Country where clinical trial is conducted

United States, 

Outcome

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