MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
NCT ID: NCT03291067
Last Updated: 2025-12-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
375 participants
INTERVENTIONAL
2017-10-09
2018-11-09
Brief Summary
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Detailed Description
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* Moderate: sensation of heat with sweating, able to continue activity
* Severe: sensation of heat with sweating, causing cessation of activity This study is comprised of a screening period, a run-in period and a 12-week double-blind treatment period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MT-8554 1mg
MT-8554 1mg
MT-8554 1mg QD, oral, 12 weeks
MT-8554 5mg
MT-8554 5mg
MT-8554 5mg QD, oral, 12 weeks
MT-8554 10mg
MT-8554 10mg
MT-8554 10mg QD, oral, 12 weeks
Placebo
Placebo
Placebo QD, oral, 12 weeks
Interventions
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MT-8554 1mg
MT-8554 1mg QD, oral, 12 weeks
MT-8554 5mg
MT-8554 5mg QD, oral, 12 weeks
MT-8554 10mg
MT-8554 10mg QD, oral, 12 weeks
Placebo
Placebo QD, oral, 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Provide written informed consent to participate in this study
* Spontaneous amenorrhea for ≥12 months; or spontaneous amenorrhea for at least 6 months and with follicle stimulating hormone (FSH) levels \>40 mIU/mL; or documented bilateral salpingo oophorectomy ≥6 weeks, with or without hysterectomy
* 7 or more moderate to severe VMS per day, or 50 or more moderate to severe VMS per week
* Have a consistent bedtime on at least 5 nights per week
* Mean VMS frequency during the Placebo Run in period does not drop by more than 50% from the mean level reported for 2 weeks during the Screening period
* VMS diary compliance \>50%
* In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements
Exclusion Criteria
* History of any cancer within 5 years except for basal cell carcinoma
* History of undiagnosed abnormal vaginal bleeding
* History of Hepatitis B, Hepatitis C or HIV
* History of psychiatric illness, excessive alcohol intake or use of recreational drugs who are unsuitable for study enrollment and compliance
* Presence or history of severe adverse reaction or allergy to any drug
* Peripheral vascular disease or disorders with associated vasculopathies
* Clinically significant conditions which could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator
* Endometrial thickness of \>=5 mm as measured by transvaginal ultrasound
* Abnormal result from baseline endometrial biopsy (i.e., endometrial hyperplasia or endometrial cancer)
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin ≥2.0 × upper limit of normal (ULN) above the reference range
* Subjects of childbearing potential
18 Years
FEMALE
No
Sponsors
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Tanabe Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Head of Medical Science
Role: STUDY_DIRECTOR
Tanabe Pharma America, Inc.
Locations
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Research Site
Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Phoenix, Arizona, United States
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Norwalk, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
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New London, Connecticut, United States
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New London, Connecticut, United States
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Aventura, Florida, United States
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Clearwater, Florida, United States
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Crystal River, Florida, United States
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Fort Myers, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Ponte Vedra, Florida, United States
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Port Saint Lucie, Florida, United States
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Sarasota, Florida, United States
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Sarasota, Florida, United States
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Wellington, Florida, United States
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West Palm Beach, Florida, United States
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Sandy Springs, Georgia, United States
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Idaho Falls, Idaho, United States
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Ankeny, Iowa, United States
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Wichita, Kansas, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Kalamazoo, Michigan, United States
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Saginaw, Michigan, United States
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Saginaw, Michigan, United States
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Kansas City, Missouri, United States
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Missoula, Montana, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Lawrenceville, New Jersey, United States
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Morehead City, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Englewood, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Bristol, Tennessee, United States
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Jackson, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Fort Worth, Texas, United States
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Schertz, Texas, United States
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Draper, Utah, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Covington, Washington, United States
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Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MT-8554-A01
Identifier Type: -
Identifier Source: org_study_id