Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms
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
1 other identifier
interventional
190
1 country
53
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2018
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2018
CompletedStudy Start
First participant enrolled
April 18, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2019
CompletedResults Posted
Study results publicly available
October 3, 2022
CompletedJanuary 23, 2026
January 1, 2026
1.6 years
March 29, 2018
June 26, 2022
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (8)
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 Outcomes (2)
Change in Average Daily Frequency of Moderate to Severe VMS
Baseline and 52 Weeks
Change in Average Daily Severity Score of Mild to Severe VMS
Baseline and 52 Weeks
Study Arms (1)
Open Label
EXPERIMENTALMT-8554
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent to participate in this study.
- Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12.
You may not qualify if:
- Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Research Site
Birmingham, Alabama, 35209, United States
Research Site
Dothan, Alabama, 36303, United States
Research Site
Phoenix, Arizona, 85032, United States
Research Site
Norwalk, California, 90650, United States
Research Site
Sacramento, California, 94203, United States
Research Site
San Diego, California, 92111, United States
Research Site
Denver, Colorado, 80209, United States
Research Site
New London, Connecticut, 33176, United States
Research Site
Clearwater, Florida, 33759, United States
Research Site
Crystal River, Florida, 34429, United States
Research Site
Fort Myers, Florida, 33900, United States
Research Site
Hialeah, Florida, 33012, United States
Research Site
Hialeah, Florida, 33016, United States
Research Site
Jacksonville, Florida, 32256, United States
Research Site
Jupiter, Florida, 33458, United States
Research Site
Miami, Florida, 33176, United States
Research Site
Miami, Florida, 33185, United States
Research Site
Orlando, Florida, 32801, United States
Research Site
Orlando, Florida, 32806, United States
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Ponte Vedra, Florida, 32081, United States
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Port Saint Lucie, Florida, 34952, United States
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Sarasota, Florida, 34231, United States
Research Site
Wellington, Florida, 33414, United States
Research Site
West Palm Beach, Florida, 33409, United States
Research Site
Sandy Springs, Georgia, 30328, United States
Research Site
Idaho Falls, Idaho, 83404, United States
Research Site
Hutchinson, Kansas, 67501, United States
Research Site
Wichita, Kansas, 67226, United States
Research Site
Marrero, Louisiana, 70072, United States
Research Site
Metairie, Louisiana, 70001, United States
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Baltimore, Maryland, 21208, United States
Research Site
Kalamazoo, Michigan, 49009, United States
Research Site
Saginaw, Michigan, 48504, United States
Research Site
Kansas City, Missouri, 64114, United States
Research Site
Missoula, Montana, 59801, United States
Research Site
Las Vegas, Nevada, 89128, United States
Research Site
Lawrenceville, New Jersey, 08648, United States
Research Site
Morehead City, North Carolina, 28557, United States
Research Site
Winston-Salem, North Carolina, 27103, United States
Research Site
Cleveland, Ohio, 44101, United States
Research Site
Columbus, Ohio, 43213, United States
Research Site
Columbus, Ohio, 43231, United States
Research Site
Englewood, Ohio, 45322, United States
Research Site
Philadelphia, Pennsylvania, 19114, United States
Research Site
Bristol, Tennessee, 37620, United States
Research Site
Jackson, Tennessee, 38305, United States
Research Site
Memphis, Tennessee, 38119, United States
Research Site
Fort Worth, Texas, 76104, United States
Research Site
Schertz, Texas, 78154, United States
Research Site
Draper, Utah, 84020, United States
Research Site
Salt Lake City, Utah, 84107, United States
Research Site
Norfolk, Virginia, 23502, United States
Research Site
Seattle, Washington, 98101, United States
Results Point of Contact
- Title
- Clinical Trials, Information Desk
- Organization
- Tanabe Pharma America, Inc.
Study Officials
- STUDY DIRECTOR
Head of Medical Science
Tanabe Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2018
First Posted
May 30, 2018
Study Start
April 18, 2018
Primary Completion
November 15, 2019
Study Completion
November 15, 2019
Last Updated
January 23, 2026
Results First Posted
October 3, 2022
Record last verified: 2026-01