MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women

NCT03291067 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MT-8554-A01
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 63

Brief Summary

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

Conditions

Menopause Hot Flashes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Percentage of Responders at Weeks 4 and 12

  Week 4 and Week 12

• Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12

  Baseline, Weeks 4 and 12

Study Arms (4)

MT-8554 1mg

EXPERIMENTAL

Drug: MT-8554 1mg

MT-8554 5mg

EXPERIMENTAL

Drug: MT-8554 5mg

MT-8554 10mg

EXPERIMENTAL

Drug: MT-8554 10mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MT-8554 5mg DRUG

MT-8554 5mg QD, oral, 12 weeks

MT-8554 5mg

MT-8554 10mg DRUG

MT-8554 10mg QD, oral, 12 weeks

MT-8554 10mg

Placebo DRUG

Placebo QD, oral, 12 weeks

Placebo

MT-8554 1mg DRUG

MT-8554 1mg QD, oral, 12 weeks

MT-8554 1mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma America, Inc.: lead

Study Sites (63)

Research Site

Birmingham, Alabama, 35209, United States

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Dothan, Alabama, 36303, United States

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Phoenix, Arizona, 85032, United States

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Norwalk, California, 90650, United States

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Sacramento, California, 95821, United States

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San Diego, California, 92111, United States

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Denver, Colorado, 80209, United States

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New London, Connecticut, 06320, United States

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New London, Connecticut, 33176, United States

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Aventura, Florida, 33180, United States

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Clearwater, Florida, 33759, United States

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Crystal River, Florida, 34429, United States

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Fort Myers, Florida, 33912, United States

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Hialeah, Florida, 33012, United States

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Hialeah, Florida, 33016, United States

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Jacksonville, Florida, 32216, United States

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Jacksonville, Florida, 32256, United States

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Jupiter, Florida, 33458, United States

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Miami, Florida, 33176, United States

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Miami, Florida, 33185, United States

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Miami, Florida, 33186, United States

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Orlando, Florida, 32801, United States

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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

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Sarasota, Florida, 34239, United States

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Wellington, Florida, 33414, United States

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West Palm Beach, Florida, 33409, United States

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Sandy Springs, Georgia, 30328, United States

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Idaho Falls, Idaho, 83404, United States

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Ankeny, Iowa, 50023, United States

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Wichita, Kansas, 67226, United States

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Marrero, Louisiana, 70072, United States

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Metairie, Louisiana, 70001, United States

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Baltimore, Maryland, 21208, United States

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Kalamazoo, Michigan, 49009, United States

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Saginaw, Michigan, 48504, United States

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Saginaw, Michigan, 48604, United States

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Kansas City, Missouri, 64114, United States

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Missoula, Montana, 59808, United States

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Las Vegas, Nevada, 89113, United States

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Las Vegas, Nevada, 89128, United States

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Lawrenceville, New Jersey, 08648, United States

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Morehead City, North Carolina, 28557, United States

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Winston-Salem, North Carolina, 27103, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43213, United States

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Columbus, Ohio, 43231, United States

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Englewood, Ohio, 45322, United States

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Philadelphia, Pennsylvania, 19114, United States

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Bristol, Tennessee, 37620, United States

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Jackson, Tennessee, 38305, United States

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Knoxville, Tennessee, 37920, United States

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Memphis, Tennessee, 38119, United States

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Fort Worth, Texas, 76104, United States

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Schertz, Texas, 78154, United States

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Draper, Utah, 84020, United States

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Ogden, Utah, 84403, United States

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Salt Lake City, Utah, 84107, United States

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Norfolk, Virginia, 23502, United States

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Covington, Washington, 98042, United States

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Seattle, Washington, 98105, United States

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Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma America, Inc.

information.US@mb.tanabe-pharma.com

Please e-mail

Study Officials

• Head of Medical Science

  Tanabe Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: October 9, 2017
• Primary Completion: October 19, 2018
• Study Completion: November 9, 2018
• Last Updated: January 23, 2026
• Results First Posted: January 4, 2022

Record last verified: 2026-01

Locations

US (63)