Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Development America, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Open Label
MT-8554
 Drug: MT-8554
MT-8554 Oral


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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. Incidence of 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 ]
  2. Change in average daily severity of mild to severe VMS [ Time Frame: Baseline and 52 Weeks ]
    Severity of VMS is measured by mild, moderate or severe


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Show Show 53 study locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Development America, Inc.
Investigators
Layout table for investigator information
Study Director: Head of Clinical Development, Mitsubishi Tanabe Pharma Development America, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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
Last Update Posted: November 13, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No