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Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541200
Recruitment Status : Completed
First Posted : May 30, 2018
Results First Posted : October 3, 2022
Last Update Posted : October 3, 2022
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Development America, Inc.

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Vasomotor Symptoms (VMS) Drug: MT-8554 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 15, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label
MT-8554
 Drug: MT-8554
MT-8554 Oral


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541200


Locations
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Sponsors and Collaborators
Mitsubishi Tanabe Pharma Development America, Inc.
Investigators
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Study Director: Head of Clinical Development, Mitsubishi Tanabe Pharma Development America, Inc.
  Study Documents (Full-Text)

Documents provided by Mitsubishi Tanabe Pharma Development America, Inc.:
Study Protocol  [PDF] August 13, 2019
Statistical Analysis Plan  [PDF] December 16, 2019

More Information
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Responsible Party: Mitsubishi Tanabe Pharma Development America, Inc.
ClinicalTrials.gov Identifier: NCT03541200    
Other Study ID Numbers: MT-8554-A02
First Posted: May 30, 2018    Key Record Dates
Results First Posted: October 3, 2022
Last Update Posted: October 3, 2022
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No