MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women

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: Completed
• Conditions: Menopause Hot Flashes
• Intervention / Treatment: Drug: MT-8554 1mg; Drug: MT-8554 5mg; Drug: MT-8554 10mg; Drug: Placebo

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: Interventional
• Enrollment (Actual): 375
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at 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	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

Outcome Measure	Measure Description	Time Frame
Percentage of Responders at Weeks 4 and 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	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

• Sponsor: Tanabe Pharma America, Inc.
• Investigators: Study Director: Head of Medical Science, Tanabe Pharma America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): October 19, 2018
• Study Completion (Actual): November 9, 2018

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID 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