Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms
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ClinicalTrials.gov Identifier: NCT03541200 |
Recruitment Status :
Completed
First Posted : May 30, 2018
Results First Posted : October 3, 2022
Last Update Posted : October 3, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vasomotor Symptoms (VMS) | Drug: MT-8554 | Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Open Label
MT-8554
|
Drug: MT-8554
MT-8554 Oral |
- Percentage of Subjects With Adverse Events [ Time Frame: 52 Weeks ]
- Percentage of Subjects With Serious Adverse Events [ Time Frame: 52 Weeks ]
- Percentage of Subjects With Clinical Laboratory Tests Abnormalities [ Time Frame: 52 Weeks ]Hematology, biochemistry, coagulation and urinalysis
- Change in Blood Pressure [ Time Frame: Baseline and 52 Weeks ]Systolic and diastolic blood pressure
- Change in Heart Rate [ Time Frame: Baseline and 52 Weeks ]
- Change in ECG Parameters [ Time Frame: Baseline and 52 Weeks ]PR, QRS, QT and QTc
- Change in Endometrial Thickness as Measured by Transvaginal Ultrasound [ Time Frame: Baseline and 52 Weeks ]
- Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy [ Time Frame: 52 Weeks ]
- 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
- 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).

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

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

Study Director: | Head of Clinical Development, | Mitsubishi Tanabe Pharma Development America, Inc. |
Documents provided by Mitsubishi Tanabe Pharma Development America, Inc.:
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |