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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental | MT-8554 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-8554 | Drug | MT-8554 Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Hematology, biochemistry, coagulation and urinalysis | 52 Weeks |
| Change in Blood Pressure | Systolic and diastolic blood pressure | Baseline and 52 Weeks |
| Change in Heart Rate | Baseline and 52 Weeks | |
| Change in ECG Parameters | PR, QRS, QT and QTc | Baseline and 52 Weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 52 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Head of Medical Science | Tanabe Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | United States | ||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 13, 2019 | Jun 23, 2022 |
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| 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). | Baseline and 52 Weeks |
| Dothan |
| Alabama |
| 36303 |
| United States |
| Research Site | Phoenix | Arizona | 85032 | United States |
| Research Site | Norwalk | California | 90650 | United States |
| Research Site | Sacramento | California | 94203 | United States |
| Research Site | San Diego | California | 92111 | United States |
| Research Site | Denver | Colorado | 80209 | United States |
| Research Site | New London | Connecticut | 33176 | United States |
| Research Site | Clearwater | Florida | 33759 | United States |
| Research Site | Crystal River | Florida | 34429 | United States |
| Research Site | Fort Myers | Florida | 33900 | United States |
| Research Site | Hialeah | Florida | 33012 | United States |
| Research Site | Hialeah | Florida | 33016 | United States |
| Research Site | Jacksonville | Florida | 32256 | United States |
| Research Site | Jupiter | Florida | 33458 | United States |
| Research Site | Miami | Florida | 33176 | United States |
| Research Site | Miami | Florida | 33185 | United States |
| Research Site | Orlando | Florida | 32801 | United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Research Site | Ponte Vedra | Florida | 32081 | United States |
| Research Site | Port Saint Lucie | Florida | 34952 | United States |
| Research Site | Sarasota | Florida | 34231 | United States |
| Research Site | Wellington | Florida | 33414 | United States |
| Research Site | West Palm Beach | Florida | 33409 | United States |
| Research Site | Sandy Springs | Georgia | 30328 | United States |
| Research Site | Idaho Falls | Idaho | 83404 | United States |
| Research Site | Hutchinson | Kansas | 67501 | United States |
| Research Site | Wichita | Kansas | 67226 | United States |
| Research Site | Marrero | Louisiana | 70072 | United States |
| Research Site | Metairie | Louisiana | 70001 | United States |
| Research Site | Baltimore | Maryland | 21208 | United States |
| Research Site | Kalamazoo | Michigan | 49009 | United States |
| Research Site | Saginaw | Michigan | 48504 | United States |
| Research Site | Kansas City | Missouri | 64114 | United States |
| Research Site | Missoula | Montana | 59801 | United States |
| Research Site | Las Vegas | Nevada | 89128 | United States |
| Research Site | Lawrenceville | New Jersey | 08648 | United States |
| Research Site | Morehead City | North Carolina | 28557 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Cleveland | Ohio | 44101 | United States |
| Research Site | Columbus | Ohio | 43213 | United States |
| Research Site | Columbus | Ohio | 43231 | United States |
| Research Site | Englewood | Ohio | 45322 | United States |
| Research Site | Philadelphia | Pennsylvania | 19114 | United States |
| Research Site | Bristol | Tennessee | 37620 | United States |
| Research Site | Jackson | Tennessee | 38305 | United States |
| Research Site | Memphis | Tennessee | 38119 | United States |
| Research Site | Fort Worth | Texas | 76104 | United States |
| Research Site | Schertz | Texas | 78154 | United States |
| Research Site | Draper | Utah | 84020 | United States |
| Research Site | Salt Lake City | Utah | 84107 | United States |
| Research Site | Norfolk | Virginia | 23502 | United States |
| Research Site | Seattle | Washington | 98101 | United States |
| COMPLETED |
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| NOT COMPLETED |
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3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Adverse Events | 3 subjects did not take any study medication so these subjects were excluded from the Safety Population. | Posted | Number | percentage of subjects | 52 Weeks |
|
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| |||||||||||||||||||||||||||
| Primary | Percentage of Subjects With Serious Adverse Events | 3 subjects did not take any study medication so these subjects were excluded from the Safety Population. | Posted | Number | percentage of subjects | 52 Weeks |
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Subjects With Clinical Laboratory Tests Abnormalities | Hematology, biochemistry, coagulation and urinalysis | 3 subjects did not take any study medication so these subjects were excluded from the Safety Population. | Posted | Number | percentage of subjects | 52 Weeks |
|
| |||||||||||||||||||||||||||
| Primary | Change in Blood Pressure | Systolic and diastolic blood pressure | 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". | Posted | Mean | Standard Deviation | mmHg | Baseline and 52 Weeks |
|
| ||||||||||||||||||||||||||
| Primary | Change in Heart Rate | 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". | Posted | Mean | Standard Deviation | beats/min | Baseline and 52 Weeks |
|
| |||||||||||||||||||||||||||
| Primary | Change in ECG Parameters | PR, QRS, QT and QTc | 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". | Posted | Mean | Standard Deviation | msec | Baseline and 52 Weeks |
|
| ||||||||||||||||||||||||||
| Primary | Change in Endometrial Thickness as Measured by Transvaginal Ultrasound | 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". | Posted | Mean | Standard Deviation | mm | Baseline and 52 Weeks |
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| Primary | Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy | 3 subjects did not take any study medication so these subjects were excluded from the Safety Population. | Posted | Number | percentage of subjects | 52 Weeks |
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| 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 | 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". | Posted | Mean | Standard Deviation | episodes/day | Baseline and 52 Weeks |
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| 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). | 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". | Posted | Mean | Standard Deviation | units on a scale | Baseline and 52 Weeks |
|
|
52 weeks
3 subjects did not take any study medication so these subjects were excluded from the Safety Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 187 | 6 | 187 | 91 | 187 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Cystocele | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Rectocele | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Diverticulum | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Bacterial vaginosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Body temperature decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Electrocardiogram abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| International normalised ratio increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Prothrombin time prolonged | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Burning sensation | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypogeusia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma America, Inc. | Please email | information.US@mb.tanabe-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2019 | Jun 23, 2022 | SAP_001.pdf |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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