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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1162-5028 | Registry Identifier | WHO | |
| 172837 | Registry Identifier | HC-CTD |
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The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (<50 ng/dL).
The drug being tested in this study is called relugolix (TAK-385). Relugolix is being tested to treat people who have prostate cancer. This study will look at achieving and maintaining testosterone suppression (<50 ng/dL).
The study enrolled 136 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
Relugolix was administered starting with a 320 mg (loading dose), followed by relugolix 80 mg or 120 mg tablets, for 48 weeks plus an optional 48-week extension at the investigator's discretion. Patients randomized to leuprorelin were administered 22.5 mg subcutaneously on Day 1 and every 12 weeks for 4 injections.
This multicenter trial was conducted in the United States and Canada. The overall time to participate in this study was 114.4 weeks. Participants made multiple visits to the clinic and at 12 weeks after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relugolix 80 mg | Experimental | Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. |
|
| Relugolix 120 mg | Experimental | Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. |
|
| Leuprorelin 22.5 mg | Active Comparator | Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relugolix | Drug | Relugolix tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Effective Castration Rate Over 24 Weeks | Effective Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter [nmol/L]) at all scheduled visits beginning after 4 weeks of treatment. | Day 1 of Week 5 to Day 1 of Week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Vital signs included oral temperature, pulse rate, supine systolic and diastolic blood pressure, standing systolic and diastolic blood pressure, and weight. Any TEAEs that were associated with vital signs were reported. | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks |
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Inclusion Criteria
Each participant must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion Criteria
Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
Participants with a diagnosis of prostate cancer were enrolled in 1 of 2 dose levels of TAK-385 (80 or 120 mg) or leuprorelin 22.5 mg.
Participants took part in the study at 23 investigative sites in Canada and the United States from 26 March 2014 to 23 February 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Relugolix 80 mg | Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Leuprorelin | Drug | Leuprorelin subcutaneous injection |
|
| Number of Participants With TEAEs Related to Physical Examination | Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10) including slit lamp examination of the anterior eye. Any TEAEs Related to physical examination were reported. | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks |
| Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings | A single 12-lead ECG was performed. ECGs were read and interpreted locally and reviewed if indicated by the study monitor. ECG abnormalities were reported as AEs. | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks |
| Number of Participants With TEAES Related to Clinical Laboratory Test Results | Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention. | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks |
| Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any AE that results in death, is life threatening, requires hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks |
| Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks | PSA Response is defined as a reduction in PSA from Baseline and is reported for 2 categories: ≥ 50% reduction and ≥ 90% reduction. | Week 5, Day 1 |
| Prostate-Specific Antigen Nadir | PSA nadir is the lowest PSA achieved after treatment. | During Weeks 1 to 24 |
| Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24 | Blood was collected and serum concentrations of PSA were obtained using a validated laboratory test at a central laboratory facility. | Day 1 of Weeks 13 and 25 |
| Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL | During Weeks 1 to 24 |
| TAK-385 Plasma Concentrations | Day 1 of Weeks 1, 2, 3, 5, 9, 13, 17, 25, 37, 49 pre-dose; Day 4 of Week 1 pre-dose; Day 1 of Weeks 5, 13, 2 hrs post-dose |
| Serum Luteinizing Hormone (LH) Concentrations | Blood was collected and serum concentrations of LH in milli international units per milliliters (mIU/mL) were obtained using a validated laboratory test at a central laboratory facility. | Baseline and Day 4 of Week 1, Day 1 of Weeks 2, 3, 5,13, 25 and 49, End of Treatment (EOT - 106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
| Serum Follicle Stimulating Hormone (FSH) Concentrations | Blood was collected and serum concentrations of FSH were obtained using a validated laboratory test at a central laboratory facility. | Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
| Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Blood was collected and serum concentrations of SHBG were obtained using a validated laboratory test at a central laboratory facility. | Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | EORTC QLQ-PR25 is an EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer consisting of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions use are answered using a 4-point scale: 1=Not at all to 4 =Very much. All raw domain scores are linearly transformed to a 0 to 100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual). A positive change from Baseline in activity or functioning scales and negative change from Baseline in symptom scales indicates improvement. | Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
| Percent Change From Baseline of Aging Male Survey (AMS) Total Score | AMS scale is a self-administered questionnaire used to: 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between 1=none to 5=extremely severe for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms. | Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
| Change From Baseline in EORTC QLQ-C30 | The EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used a 4-point scale (1=Not at all to 4=Very much); 2 questions used a 7-point scale (1= Very poor to 7=Excellent). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. A positive change from Baseline in quality og life or functioning scales and negative change from Baseline in symptom or difficulties scales indicates improvement. | Day 1 of Weeks 5, 13, 25, 37, 49, 73, 97, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
| San Diego |
| California |
| United States |
| Denver | Colorado | United States |
| Daytona Beach | Florida | United States |
| Jeffersonville | Indiana | United States |
| Wichita | Kansas | United States |
| Shreveport | Louisiana | United States |
| Omaha | Nebraska | United States |
| Lawrenceville | New Jersey | United States |
| Garden City | New York | United States |
| Syracuse | New York | United States |
| Cincinnati | Ohio | United States |
| Springfield | Oregon | United States |
| Lancaster | Pennsylvania | United States |
| Myrtle Beach | South Carolina | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Virginia Beach | Virginia | United States |
| Abbotsford British Columbia | British Columbia | Canada |
| Vancouver | British Columbia | Canada |
| Montreal | Quebec | Canada |
| Québec | Canada |
| Relugolix 120 mg |
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion. |
| FG002 | Leuprorelin 22.5 mg | Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks). |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Relugolix 80 mg | Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion. |
| BG001 | Relugolix 120 mg | Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion. |
| BG002 | Leuprorelin 22.5 mg | Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Full Range | cm |
| |||||||||||||||
| Weight | Mean | Full Range | kg |
| |||||||||||||||
| Body Mass Index | Mean | Full Range | kg/m^2 |
|
| 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 Participants With Effective Castration Rate Over 24 Weeks | Effective Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter [nmol/L]) at all scheduled visits beginning after 4 weeks of treatment. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 of Week 5 to Day 1 of Week 25 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Vital signs included oral temperature, pulse rate, supine systolic and diastolic blood pressure, standing systolic and diastolic blood pressure, and weight. Any TEAEs that were associated with vital signs were reported. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With TEAEs Related to Physical Examination | Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10) including slit lamp examination of the anterior eye. Any TEAEs Related to physical examination were reported. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings | A single 12-lead ECG was performed. ECGs were read and interpreted locally and reviewed if indicated by the study monitor. ECG abnormalities were reported as AEs. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any AE that results in death, is life threatening, requires hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks | PSA Response is defined as a reduction in PSA from Baseline and is reported for 2 categories: ≥ 50% reduction and ≥ 90% reduction. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 5, Day 1 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Prostate-Specific Antigen Nadir | PSA nadir is the lowest PSA achieved after treatment. | Safety population included all randomized participants who received at least 1 dose of study drug. Here number of participants analyzed are participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | micrograms per liter (µg/L) | During Weeks 1 to 24 |
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| Secondary | Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24 | Blood was collected and serum concentrations of PSA were obtained using a validated laboratory test at a central laboratory facility. | Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint. | Posted | Mean | Standard Deviation | μg/L | Day 1 of Weeks 13 and 25 |
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| Secondary | Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL | Safety population included all randomized participants who received at least 1 dose of study drug. If a participant has all post first dose testosterone measurements >= 50 ng/dL, the participant's time to castration was censored at the last testosterone measurement that is >= 50 ng/dL. | Posted | Median | Full Range | days | During Weeks 1 to 24 |
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| Secondary | TAK-385 Plasma Concentrations | Safety population included all randomized participants who received at least 1 dose of study drug (TAK-835). Here 'n' is the number of participants analyzed at the specific timepoint. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Day 1 of Weeks 1, 2, 3, 5, 9, 13, 17, 25, 37, 49 pre-dose; Day 4 of Week 1 pre-dose; Day 1 of Weeks 5, 13, 2 hrs post-dose |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Serum Luteinizing Hormone (LH) Concentrations | Blood was collected and serum concentrations of LH in milli international units per milliliters (mIU/mL) were obtained using a validated laboratory test at a central laboratory facility. | Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint. | Posted | Mean | Standard Deviation | mIU/mL | Baseline and Day 4 of Week 1, Day 1 of Weeks 2, 3, 5,13, 25 and 49, End of Treatment (EOT - 106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | Serum Follicle Stimulating Hormone (FSH) Concentrations | Blood was collected and serum concentrations of FSH were obtained using a validated laboratory test at a central laboratory facility. | Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint. | Posted | Mean | Standard Deviation | IU/L | Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Blood was collected and serum concentrations of SHBG were obtained using a validated laboratory test at a central laboratory facility. | Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint. | Posted | Mean | Standard Deviation | nanomoles per liter (nmol/L) | Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | EORTC QLQ-PR25 is an EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer consisting of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions use are answered using a 4-point scale: 1=Not at all to 4 =Very much. All raw domain scores are linearly transformed to a 0 to 100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual). A positive change from Baseline in activity or functioning scales and negative change from Baseline in symptom scales indicates improvement. | Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | AMS scale is a self-administered questionnaire used to: 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between 1=none to 5=extremely severe for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms. | Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint. | Posted | Mean | Standard Deviation | percent change | Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-C30 | The EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used a 4-point scale (1=Not at all to 4=Very much); 2 questions used a 7-point scale (1= Very poor to 7=Excellent). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. A positive change from Baseline in quality og life or functioning scales and negative change from Baseline in symptom or difficulties scales indicates improvement. | Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint. | Posted | Mean | Standard Deviation | score on a scale | Day 1 of Weeks 5, 13, 25, 37, 49, 73, 97, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) |
|
From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Safety population included all randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Relugolix 80 mg | Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion. | 10 | 56 | 53 | 56 | ||
| EG001 | Relugolix 120 mg | Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion. | 7 | 54 | 50 | 54 | ||
| EG002 | Leuprorelin 22.5 mg | Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks). | 2 | 24 | 23 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with leuprorelin 22.5 mg and is not related. |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 19.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with relugolix 80 mg and is not related. |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with relugolix 80 mg is not related. |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 19.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with relugolix 120 mg and is not related. |
|
| Sudden death | General disorders | MedDRA 19.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with relugolix 120 mg and is not related. |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Corneal dystrophy | Congenital, familial and genetic disorders | MedDRA 19.0 | Systematic Assessment |
|
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C561634 | relugolix |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Canada |
|
|
|
| OG002 |
| Leuprorelin 22.5 mg |
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks). |
|
|
|
|
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|
| OG002 | Leuprorelin 22.5 mg | Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks). |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
|
|
|
|
|
|
| Relugolix 120 mg |
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion. |
| OG002 | Leuprorelin 22.5 mg | Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks). |
|
|
| OG002 | Leuprorelin 22.5 mg | Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks). |
|
|
| OG001 | Relugolix 120 mg | Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion. |
| OG002 | Leuprorelin 22.5 mg | Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks). |
|
|