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

Phase 2

Completed

• Conditions: Vasomotor Symptoms (VMS)
• Interventions: Drug: MT-8554

• Registration Number: NCT03541200
• Lead Sponsor: Mitsubishi Tanabe Pharma America Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-29
• Study Start: 2018-04-18
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-30
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-15
• Disposition First Submitted: 2020-11-10
• Results First Submitted: 2022-06-26
• Results First Submitted QC: 2022-09-21
• Disposition First Submitted QC: 2022-09-21
• Results First Posted: 2022-10-03
• Disposition First Posted: 2022-10-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label	MT-8554	MT-8554

Primary Outcome Measures

Name	Time	Method
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	52 Weeks	Hematology, biochemistry, coagulation and urinalysis
Change in Heart Rate	Baseline and 52 Weeks
Change in Endometrial Thickness as Measured by Transvaginal Ultrasound	Baseline and 52 Weeks
Change in Blood Pressure	Baseline and 52 Weeks	Systolic and diastolic blood pressure
Change in ECG Parameters	Baseline and 52 Weeks	PR, QRS, QT and QTc
Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy	52 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in Average Daily Frequency of Moderate to Severe VMS	Baseline and 52 Weeks	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
Change in Average Daily Severity Score of Mild to Severe VMS	Baseline and 52 Weeks	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).

Trial Locations

Locations (1)

Research Site; 🇺🇸 Seattle, Washington, United States