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Completed

NCT Number: NCT03541200

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

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Key information

Conditions

Vasomotor Symptoms (VMS)

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent to participate in this study.
  • Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12.

Exclusion criteria

  • Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)

Treatment and study plan

MT-8554

Drug

MT-8554 Oral

Primary outcomes

  1. Percentage of Subjects With Adverse Events

    Time frame: 52 Weeks

  2. Percentage of Subjects With Serious Adverse Events

    Time frame: 52 Weeks

  3. Percentage of Subjects With Clinical Laboratory Tests Abnormalities

    Time frame: 52 Weeks

    Hematology, biochemistry, coagulation and urinalysis

  4. Change in Blood Pressure

    Time frame: Baseline and 52 Weeks

    Systolic and diastolic blood pressure

  5. Change in Heart Rate

    Time frame: Baseline and 52 Weeks

  6. Change in ECG Parameters

    Time frame: Baseline and 52 Weeks

    PR, QRS, QT and QTc

  7. Change in Endometrial Thickness as Measured by Transvaginal Ultrasound

    Time frame: Baseline and 52 Weeks

  8. Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy

    Time frame: 52 Weeks

Secondary outcomes

  1. Change in Average Daily Frequency of Moderate to Severe VMS

    Time frame: Baseline and 52 Weeks

    Subjects were asked to record frequency and severity of VMS in an electronic diary. Severity levels are defined as follows.

    Mild : Sensation of heat without sweating

    Moderate : Sensation of heat with sweating, able to continue activity

    Severe : Sensation of heat with sweating, causing cessation of activity

  2. Change in Average Daily Severity Score of Mild to Severe VMS

    Time frame: Baseline and 52 Weeks

    Baseline VMS severity score : (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse)

    VMS severity score for a specific week during the open label treatment period :(1xFmi+2xFmo+3xFse)/(Fmi+Fmo+Fse)

    Fmi, Fmo, and Fse are the daily frequencies of mild, moderate, and severe VMS respectively.

    The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity).

Sponsors and collaborators

Lead sponsor

Tanabe Pharma America, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 30, 2018
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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