Trial Outcomes & Findings for Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms (NCT NCT03541200)
NCT ID: NCT03541200
Last Updated: 2025-12-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
190 participants
Primary outcome timeframe
52 Weeks
Results posted on
2025-12-31
Participant Flow
Participant milestones
| Measure |
MT-8554
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Overall Study
STARTED
|
190
|
|
Overall Study
COMPLETED
|
77
|
|
Overall Study
NOT COMPLETED
|
113
|
Reasons for withdrawal
| Measure |
MT-8554
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Overall Study
Adverse Event
|
19
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|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Protocol Violation
|
51
|
|
Overall Study
Withdrawal by Subject
|
23
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Overall Study
other
|
8
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Baseline Characteristics
Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms
Baseline characteristics by cohort
| Measure |
MT-8554
n=187 Participants
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Age, Continuous
|
54.6 years
STANDARD_DEVIATION 6.66 • n=1000 Participants
|
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Sex: Female, Male
Female
|
187 Participants
n=1000 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1000 Participants
|
PRIMARY outcome
Timeframe: 52 WeeksPopulation: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
Outcome measures
| Measure |
MT-8554
n=187 Participants
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Percentage of Subjects With Adverse Events
|
56.7 percentage of subjects
|
PRIMARY outcome
Timeframe: 52 WeeksPopulation: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
Outcome measures
| Measure |
MT-8554
n=187 Participants
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Percentage of Subjects With Serious Adverse Events
|
3.2 percentage of subjects
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PRIMARY outcome
Timeframe: 52 WeeksPopulation: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
Hematology, biochemistry, coagulation and urinalysis
Outcome measures
| Measure |
MT-8554
n=187 Participants
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Percentage of Subjects With Clinical Laboratory Tests Abnormalities
|
15.5 percentage of subjects
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PRIMARY outcome
Timeframe: Baseline and 52 WeeksPopulation: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population. The number of subjects with SBP and DBP results at Week 52 are mentioned in each row "number of participants analyzed".
Systolic and diastolic blood pressure
Outcome measures
| Measure |
MT-8554
n=187 Participants
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Change in Blood Pressure
Systolic Blood Pressure
|
1.3 mmHg
Standard Deviation 11.36
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|
Change in Blood Pressure
Diastolic Blood Pressure
|
-0.4 mmHg
Standard Deviation 7.65
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PRIMARY outcome
Timeframe: Baseline and 52 WeeksPopulation: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population. The number of subjects with heart rate result at Week 52 are mentioned in row "number of participants analyzed".
Outcome measures
| Measure |
MT-8554
n=156 Participants
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Change in Heart Rate
|
2.6 beats/min
Standard Deviation 7.96
|
PRIMARY outcome
Timeframe: Baseline and 52 WeeksPopulation: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population. The number of subjects with each parameter result at Week 52 are mentioned in each row "number of participants analyzed".
PR, QRS, QT and QTc
Outcome measures
| Measure |
MT-8554
n=187 Participants
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Change in ECG Parameters
PR
|
0.4 msec
Standard Deviation 16.34
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|
Change in ECG Parameters
QRS
|
-0.2 msec
Standard Deviation 9.46
|
|
Change in ECG Parameters
QT
|
-6.8 msec
Standard Deviation 22.86
|
|
Change in ECG Parameters
QTcF
|
-0.6 msec
Standard Deviation 18.60
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Change in ECG Parameters
QTcB
|
1.2 msec
Standard Deviation 19.66
|
PRIMARY outcome
Timeframe: Baseline and 52 WeeksPopulation: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population. The number of subjects with endometrial thickness result at Week 52 are mentioned in row "number of participants analyzed".
Outcome measures
| Measure |
MT-8554
n=34 Participants
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Change in Endometrial Thickness as Measured by Transvaginal Ultrasound
|
-0.138 mm
Standard Deviation 1.4765
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PRIMARY outcome
Timeframe: 52 WeeksPopulation: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
Outcome measures
| Measure |
MT-8554
n=187 Participants
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline and 52 WeeksPopulation: 6 subjects did not have any post-baseline efficacy assessment so these subjects were excluded from the Intent-to-treat population.The number of subjects with VMS frequency result at Week 52 are mentioned in row "number of participants analyzed".
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
Outcome measures
| Measure |
MT-8554
n=64 Participants
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Change in Average Daily Frequency of Moderate to Severe VMS
|
-2.71 episodes/day
Standard Deviation 4.974
|
SECONDARY outcome
Timeframe: Baseline and 52 WeeksPopulation: 6 subjects did not have any post-baseline efficacy assessment so these subjects were excluded from the Intent-to-treat population.The number of subjects with VMS severity result at Week 52 are mentioned in row "number of participants analyzed".
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).
Outcome measures
| Measure |
MT-8554
n=64 Participants
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Change in Average Daily Severity Score of Mild to Severe VMS
|
-0.325 units on a scale
Standard Deviation 0.6804
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Adverse Events
MT-8554
Serious events: 6 serious events
Other events: 91 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MT-8554
n=187 participants at risk
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Infections and infestations
Diverticulitis
|
0.53%
1/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.53%
1/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.53%
1/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.53%
1/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.53%
1/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
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|
Reproductive system and breast disorders
Cystocele
|
0.53%
1/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
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Reproductive system and breast disorders
Rectocele
|
0.53%
1/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.53%
1/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.53%
1/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
Other adverse events
| Measure |
MT-8554
n=187 participants at risk
MT-8554 10mg QD for 52 weeks, followed MT-8554 1mg or 5mg or 10mg or placebo QD for 12 weeks in MT-8554-A01 study. Based upon the results of MT-8554-A01 study, the dose was changed from 10 mg to 5 mg during the study.
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|---|---|
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Investigations
Blood pressure increased
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
Blood triglycerides increased
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
Body temperature decreased
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
Electrocardiogram abnormal
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.1%
4/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
International normalised ratio increased
|
2.1%
4/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
Prothrombin time prolonged
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
6/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Nervous system disorders
Burning sensation
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Gastrointestinal disorders
Diverticulum
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
2.7%
5/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
7.5%
14/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
General disorders
Chills
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
General disorders
Fatigue
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
General disorders
Feeling cold
|
2.1%
4/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
General disorders
Feeling hot
|
4.8%
9/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Infections and infestations
Bacterial vaginosis
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Infections and infestations
Bronchitis
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Infections and infestations
Influenza
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Infections and infestations
Sinusitis
|
2.1%
4/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
10/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
3.7%
7/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.1%
4/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Injury, poisoning and procedural complications
Overdose
|
2.7%
5/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
5/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
Blood cholesterol increased
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Nervous system disorders
Headache
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Nervous system disorders
Hypoaesthesia
|
4.3%
8/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Nervous system disorders
Hypogeusia
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Nervous system disorders
Migraine
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Nervous system disorders
Paraesthesia
|
7.5%
14/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Nervous system disorders
Sciatica
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Psychiatric disorders
Depression
|
2.7%
5/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Psychiatric disorders
Insomnia
|
2.7%
5/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Vascular disorders
Flushing
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Vascular disorders
Hot flush
|
1.1%
2/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
|
Vascular disorders
Hypertension
|
1.6%
3/187 • 52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma America, Inc.
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER