Vasomotor Symptoms (VMS)
Conditions
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
Interventions
DRUGMT-8554
MT-8554 Oral
Sponsors
Tanabe Pharma America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Adverse Events | 52 Weeks | — |
| Percentage of Subjects With Serious Adverse Events | 52 Weeks | — |
| Percentage of Subjects With Clinical Laboratory Tests Abnormalities | 52 Weeks | Hematology, biochemistry, coagulation and urinalysis |
| Change in Blood Pressure | Baseline and 52 Weeks | Systolic and diastolic blood pressure |
| Change in Heart Rate | Baseline and 52 Weeks | — |
| Change in ECG Parameters | Baseline and 52 Weeks | PR, QRS, QT and QTc |
| Change in Endometrial Thickness as Measured by Transvaginal Ultrasound | Baseline and 52 Weeks | — |
| Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy | 52 Weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Daily Frequency of Moderate to Severe VMS | 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 | 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). |
Countries
United States
Contacts
STUDY_DIRECTORHead of Medical Science
Tanabe Pharma America, Inc.
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 187 |
| Total | 187 |
Baseline characteristics
| Characteristic | MT-8554 |
|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 6.66 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 138 Participants |
| Sex: Female, Male Female | 187 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 187 |
| other Total, other adverse events | 91 / 187 |
| serious Total, serious adverse events | 6 / 187 |
Outcome results
Primary
Change in Blood Pressure
Systolic and diastolic blood pressure
Time frame: Baseline and 52 Weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MT-8554 | Change in Blood Pressure | Systolic Blood Pressure | 1.3 mmHg | Standard Deviation 11.36 |
| MT-8554 | Change in Blood Pressure | Diastolic Blood Pressure | -0.4 mmHg | Standard Deviation 7.65 |
Primary
Change in ECG Parameters
PR, QRS, QT and QTc
Time frame: Baseline and 52 Weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MT-8554 | Change in ECG Parameters | PR | 0.4 msec | Standard Deviation 16.34 |
| MT-8554 | Change in ECG Parameters | QRS | -0.2 msec | Standard Deviation 9.46 |
| MT-8554 | Change in ECG Parameters | QT | -6.8 msec | Standard Deviation 22.86 |
| MT-8554 | Change in ECG Parameters | QTcF | -0.6 msec | Standard Deviation 18.6 |
| MT-8554 | Change in ECG Parameters | QTcB | 1.2 msec | Standard Deviation 19.66 |
Primary
Change in Endometrial Thickness as Measured by Transvaginal Ultrasound
Time frame: Baseline and 52 Weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MT-8554 | Change in Endometrial Thickness as Measured by Transvaginal Ultrasound | -0.138 mm | Standard Deviation 1.4765 |
Primary
Change in Heart Rate
Time frame: Baseline and 52 Weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MT-8554 | Change in Heart Rate | 2.6 beats/min | Standard Deviation 7.96 |
Primary
Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy
Time frame: 52 Weeks
Population: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MT-8554 | Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy | 0 percentage of subjects |
Primary
Percentage of Subjects With Adverse Events
Time frame: 52 Weeks
Population: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MT-8554 | Percentage of Subjects With Adverse Events | 56.7 percentage of subjects |
Primary
Percentage of Subjects With Clinical Laboratory Tests Abnormalities
Hematology, biochemistry, coagulation and urinalysis
Time frame: 52 Weeks
Population: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MT-8554 | Percentage of Subjects With Clinical Laboratory Tests Abnormalities | 15.5 percentage of subjects |
Primary
Percentage of Subjects With Serious Adverse Events
Time frame: 52 Weeks
Population: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MT-8554 | Percentage of Subjects With Serious Adverse Events | 3.2 percentage of subjects |
Secondary
Change in Average Daily Frequency of Moderate to Severe VMS
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
Time frame: Baseline and 52 Weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MT-8554 | Change in Average Daily Frequency of Moderate to Severe VMS | -2.71 episodes/day | Standard Deviation 4.974 |
Secondary
Change in Average Daily Severity Score of Mild to Severe VMS
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).
Time frame: Baseline and 52 Weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MT-8554 | Change in Average Daily Severity Score of Mild to Severe VMS | -0.325 units on a scale | Standard Deviation 0.6804 |