MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women

January 5, 2026 updated by: Tanabe Pharma America, Inc.

A Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of MT-8554 on the Frequency and Severity of Vasomotor Symptoms in Postmenopausal Women

The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase II randomized, double-blind, placebo-controlled study for dose selection in postmenopausal women with moderate to severe VMS, defined as follows:

  • 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
375

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Research Site
      • Dothan, Alabama, United States, 36303
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Research Site
    • California
      • Norwalk, California, United States, 90650
        • Research Site
      • Sacramento, California, United States, 95821
        • Research Site
      • San Diego, California, United States, 92111
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80209
        • Research Site
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Research Site
      • New London, Connecticut, United States, 33176
        • Research Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Research Site
      • Clearwater, Florida, United States, 33759
        • Research Site
      • Crystal River, Florida, United States, 34429
        • Research Site
      • Fort Myers, Florida, United States, 33912
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Hialeah, Florida, United States, 33016
        • Research Site
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Jupiter, Florida, United States, 33458
        • Research Site
      • Miami, Florida, United States, 33186
        • Research Site
      • Miami, Florida, United States, 33176
        • Research Site
      • Miami, Florida, United States, 33185
        • Research Site
      • Orlando, Florida, United States, 32806
        • Research Site
      • Orlando, Florida, United States, 32801
        • Research Site
      • Ponte Vedra, Florida, United States, 32081
        • Research Site
      • Port Saint Lucie, Florida, United States, 34952
        • Research Site
      • Sarasota, Florida, United States, 34239
        • Research Site
      • Sarasota, Florida, United States, 34231
        • Research Site
      • Wellington, Florida, United States, 33414
        • Research Site
      • West Palm Beach, Florida, United States, 33409
        • Research Site
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Research Site
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Research Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Research Site
      • Metairie, Louisiana, United States, 70001
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Research Site
      • Saginaw, Michigan, United States, 48504
        • Research Site
      • Saginaw, Michigan, United States, 48604
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Research Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Research Site
      • Las Vegas, Nevada, United States, 89113
        • Research Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Research Site
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Research Site
      • Columbus, Ohio, United States, 43213
        • Research Site
      • Columbus, Ohio, United States, 43231
        • Research Site
      • Englewood, Ohio, United States, 45322
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Research Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Research Site
      • Jackson, Tennessee, United States, 38305
        • Research Site
      • Knoxville, Tennessee, United States, 37920
        • Research Site
      • Memphis, Tennessee, United States, 38119
        • Research Site
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Research Site
      • Schertz, Texas, United States, 78154
        • Research Site
    • Utah
      • Draper, Utah, United States, 84020
        • Research Site
      • Ogden, Utah, United States, 84403
        • Research Site
      • Salt Lake City, Utah, United States, 84107
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Research Site
    • Washington
      • Covington, Washington, United States, 98042
        • Research Site
      • Seattle, Washington, United States, 98105
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Additional screening criteria check may apply for qualification:

  • 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:

Additional screening criteria check may apply for qualification:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo QD, oral, 12 weeks
Experimental: MT-8554 1mg
Drug: MT-8554 1mg
MT-8554 1mg QD, oral, 12 weeks
Experimental: MT-8554 5mg
Drug: MT-8554 5mg
MT-8554 5mg QD, oral, 12 weeks
Experimental: MT-8554 10mg
Drug: MT-8554 10mg
MT-8554 10mg QD, oral, 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12
Time Frame: Baseline, Weeks 4 and 12
The average daily frequency of moderate to severe VMS at a time point (Baseline, Weeks 4 and 12) was the average of the frequency of moderate to severe VMS of available diary days in a 7-day window. Changes in the average daily frequency of moderate to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.
Baseline, Weeks 4 and 12
Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12
Time Frame: Baseline, Weeks 4 and 12
The daily severity score of VMS was defined as (2xFmo + 3xFse)/(Fmo + Fse) for baseline, and (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse) for Weeks 4 and 12, where Fmi, Fmo, and Fse were the daily frequencies of mild, moderate, and severe VMS, respectively. The average daily severity score of mild to severe VMS at a time point (Baseline, Week 4 and Week 12) was the average of the daily severity of available diary days in the corresponding 7-day window. The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity). Change in the average daily severity score of mild to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.
Baseline, Weeks 4 and 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Responders at Weeks 4 and 12
Time Frame: Week 4 and Week 12
Subjects with cutoff number or greater reduction in the average daily frequency of moderate and severe VMS compared to baseline. The cutoff number was calculated using anchor-based method. The cutoff number was defined as numerical value to maximize the sensitivity and the specificity, using Patient Global Impression of Change (PGIC) as the anchor.
Week 4 and Week 12
Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12
Time Frame: Baseline, Weeks 4 and 12
The Insomnia Severity Index was a self-rated, 7-item validated sleep scale that measured clinical insomnia severity. The total score ranged from 0-28 where higher values indicated increased severity of insomnia.
Baseline, Weeks 4 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tanabe Pharma America, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Head of Medical Science, Tanabe Pharma America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MT-8554-A01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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