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A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02083185
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Relugolix
Drug: Leuprorelin
Enrollment 136
Recruitment Details Participants took part in the study at 23 investigative sites in Canada and the United States from 26 March 2014 to 23 February 2017.
Pre-assignment Details 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.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description 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. 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. Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Period Title: Overall Study
Started 56 56 24
Safety Population 56 54 24
Completed 36 27 17
Not Completed 20 29 7
Reason Not Completed
Lost to Follow-up             0             3             0
Withdrawal by Subject             9             15             1
Death             2             2             1
Reason not Specified             9             6             5
Study Terminated by Sponsor             0             1             0
Did not Receive Study Drug             0             2             0
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg Total
Hide Arm/Group Description 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. 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. Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks). Total of all reporting groups
Overall Number of Baseline Participants 56 54 24 134
Hide Baseline Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 56 participants 54 participants 24 participants 134 participants
72.3
(50 to 91)
72.1
(49 to 87)
68.3
(56 to 82)
70.9
(49 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 54 participants 24 participants 134 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
56
 100.0%
54
 100.0%
24
 100.0%
134
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 54 participants 24 participants 134 participants
Hispanic or Latino
4
   7.1%
4
   7.4%
2
   8.3%
10
   7.5%
Not Hispanic or Latino
51
  91.1%
50
  92.6%
22
  91.7%
123
  91.8%
Unknown or Not Reported
1
   1.8%
0
   0.0%
0
   0.0%
1
   0.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 54 participants 24 participants 134 participants
White
45
  80.4%
43
  79.6%
24
 100.0%
112
  83.6%
Black or African American
9
  16.1%
10
  18.5%
0
   0.0%
19
  14.2%
Asian
2
   3.6%
1
   1.9%
0
   0.0%
3
   2.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 54 participants 24 participants 134 participants
United States
51
  91.1%
48
  88.9%
23
  95.8%
122
  91.0%
Canada
5
   8.9%
6
  11.1%
1
   4.2%
12
   9.0%
Height  
Mean (Full Range)
Unit of measure:  Cm
Number Analyzed 56 participants 54 participants 24 participants 134 participants
176.92
(149.9 to 198.1)
177.83
(157.5 to 198.1)
177.63
(162.6 to 188.0)
177.46
(149.9 to 198.1)
Weight  
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 56 participants 54 participants 24 participants 134 participants
90.49
(56.4 to 193.2)
92.16
(57.3 to 149.5)
96.10
(68.2 to 145.9)
92.92
(56.4 to 193.2)
Body Mass Index  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 56 participants 54 participants 24 participants 134 participants
28.815
(19.51 to 54.66)
29.077
(18.13 to 39.36)
30.452
(23.03 to 41.28)
29.448
(18.13 to 54.66)
1.Primary Outcome
Title Percentage of Participants With Effective Castration Rate Over 24 Weeks
Hide Description 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.
Time Frame Day 1 of Week 5 to Day 1 of Week 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91
(80.4 to 97.0)
91
(79.7 to 96.9)
96
(78.9 to 99.9)
2.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Hide Description 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.
Time Frame From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Measure Type: Number
Unit of Measure: participants
Syncope 3 2 0
Hypertension 1 4 1
Hypotension 1 2 0
Arrhythmia 0 1 0
Bradycardia 2 0 0
Tachycardia 1 1 1
Heart rate irregular 1 0 0
Weight increased 4 2 0
Weight decreased 1 0 2
Pyrexia 3 0 0
3.Secondary Outcome
Title Number of Participants With TEAEs Related to Physical Examination
Hide Description 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.
Time Frame From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Measure Type: Number
Unit of Measure: participants
Weight increased 4 2 0
Weight decreased 1 0 2
Ophthalmological examination abnormal 1 0 0
4.Secondary Outcome
Title Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings
Hide Description 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.
Time Frame From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Measure Type: Number
Unit of Measure: participants
0 0 0
5.Secondary Outcome
Title Number of Participants With TEAES Related to Clinical Laboratory Test Results
Hide Description 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.
Time Frame From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Measure Type: Number
Unit of Measure: participants
Alanine aminotransferase increased 7 3 4
Aspartate aminotransferase increased 6 1 3
Gamma-glutamyltransferase increased 3 1 2
Blood triglycerides increased 3 0 1
Blood bilirubin increased 1 0 0
Hepatic enzyme increased 0 1 0
Prostatic specific antigen increased 1 1 1
Blood cholesterol increased 0 2 0
Low density lipoprotein increased 1 0 0
Blood glucose increased 1 1 0
Glycosylated haemoglobin increased 0 1 0
Blood creatinine increased 0 1 0
Blood lactate dehydrogenase increased 2 0 0
Blood alkaline phosphatase increased 1 0 0
Blood phosphorus increased 1 0 0
Blood potassium increased 1 0 0
Blood thyroid stimulating hormone increased 0 1 0
Blood testosterone increased 0 0 1
6.Secondary Outcome
Title Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Measure Type: Number
Unit of Measure: participants
Any Adverse Event 53 53 23
SAEs 10 7 2
7.Secondary Outcome
Title Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks
Hide Description PSA Response is defined as a reduction in PSA from Baseline and is reported for 2 categories: ≥ 50% reduction and ≥ 90% reduction.
Time Frame Week 5, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Measure Type: Number
Unit of Measure: percentage of participants
≥ 50% PSA reduction 75 83 17
≥ 90% PSA reduction 13 6 0
8.Secondary Outcome
Title Prostate-Specific Antigen Nadir
Hide Description PSA nadir is the lowest PSA achieved after treatment.
Time Frame During Weeks 1 to 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 54 53 24
Mean (Standard Deviation)
Unit of Measure: micrograms per liter (µg/L)
1.8  (7.20) 5.2  (26.15) 0.6  (1.03)
9.Secondary Outcome
Title Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24
Hide Description Blood was collected and serum concentrations of PSA were obtained using a validated laboratory test at a central laboratory facility.
Time Frame Day 1 of Weeks 13 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Mean (Standard Deviation)
Unit of Measure: μg/L
Week 13, Day 1 Number Analyzed 53 participants 53 participants 24 participants
2.651  (10.0624) 5.786  (26.4243) 0.916  (1.4478)
Week 25, Day 1 Number Analyzed 50 participants 50 participants 23 participants
1.936  (7.5731) 2.360  (7.3103) 0.624  (1.0693)
10.Secondary Outcome
Title Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL
Hide Description [Not Specified]
Time Frame During Weeks 1 to 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Median (Full Range)
Unit of Measure: days
Time to Castration (< 50 ng/dL)
4
(4 to 106)
4
(4 to 57)
29
(15 to 57)
Time to Profound Castration (< 20 ng/dL)
15
(4 to 141)
15
(4 to 189)
29
(15 to 113)
11.Secondary Outcome
Title TAK-385 Plasma Concentrations
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 56 54
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
Week 1, Day 1 pre-dose Number Analyzed 51 participants 54 participants
0  (0) 0  (0)
Week 1, Day 4 pre-dose Number Analyzed 51 participants 52 participants
9.9  (13.63) 14.2  (18.52)
Week 2, Day 1 pre-dose Number Analyzed 54 participants 53 participants
6.3  (6.32) 8.7  (10.10)
Week 3, Day 1 pre-dose Number Analyzed 55 participants 54 participants
5.4  (3.24) 10.3  (14.77)
Week 5, Day 1 pre-dose Number Analyzed 52 participants 54 participants
5.2  (2.79) 8.4  (9.85)
Week 5, Day 1, 2 hours post-dose Number Analyzed 51 participants 52 participants
25.3  (21.76) 45.4  (42.67)
Week 9, Day 1 pre-dose Number Analyzed 50 participants 52 participants
4.9  (3.47) 8.0  (5.82)
Week 13, Day 1 pre-dose Number Analyzed 53 participants 53 participants
5.5  (3.39) 9.0  (7.15)
Week 13, Day 1, 2 hours post-dose Number Analyzed 51 participants 50 participants
24.1  (23.16) 42.2  (37.04)
Week 17, Day 1 pre-dose Number Analyzed 50 participants 52 participants
6.3  (8.12) 8.9  (6.80)
Week 25, Day 1 pre-dose Number Analyzed 50 participants 49 participants
7.3  (11.07) 11.5  (14.15)
Week 37, Day 1 pre-dose Number Analyzed 44 participants 45 participants
6.3  (7.29) 10.9  (16.94)
Week 49, Day 1 pre-dose Number Analyzed 45 participants 39 participants
5.9  (4.98) 9.4  (8.32)
12.Secondary Outcome
Title Serum Luteinizing Hormone (LH) Concentrations
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Mean (Standard Deviation)
Unit of Measure: mIU/mL
Week 1, Day 4 Number Analyzed 54 participants 52 participants 22 participants
0.665  (0.6982) 0.595  (0.5467) 17.551  (13.1433)
Week 2, Day 1 Number Analyzed 53 participants 52 participants 24 participants
0.548  (0.6683) 0.638  (1.3988) 8.279  (5.8986)
Week 3, Day 1 Number Analyzed 54 participants 53 participants 22 participants
0.341  (0.5851) 0.388  (0.7887) 3.171  (2.7636)
Week 5, Day 1 Number Analyzed 54 participants 53 participants 24 participants
0.424  (1.4941) 0.203  (0.3580) 0.508  (0.4327)
Week 13, Day 1 Number Analyzed 52 participants 51 participants 24 participants
0.229  (0.6003) 0.183  (0.2542) 0.277  (0.8253)
Week 25, Day 1 Number Analyzed 49 participants 49 participants 23 participants
0.195  (0.2524) 0.175  (0.1365) 0.134  (0.0992)
Week 49, Day 1 Number Analyzed 45 participants 41 participants 20 participants
0.341  (0.3948) 0.288  (0.2479) 0.138  (0.1677)
EOT Number Analyzed 42 participants 45 participants 18 participants
3.189  (3.6928) 2.704  (2.5312) 0.585  (1.6775)
Follow-Up Number Analyzed 23 participants 23 participants 15 participants
8.624  (5.3685) 9.510  (5.2926) 0.525  (1.0187)
End of Study Number Analyzed 40 participants 31 participants 16 participants
7.182  (8.0509) 9.306  (7.9054) 1.394  (1.7702)
13.Secondary Outcome
Title Serum Follicle Stimulating Hormone (FSH) Concentrations
Hide Description Blood was collected and serum concentrations of FSH were obtained using a validated laboratory test at a central laboratory facility.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Mean (Standard Deviation)
Unit of Measure: IU/L
Week 2, Day 1 Number Analyzed 52 participants 52 participants 22 participants
3.112  (3.0612) 3.183  (2.8956) 7.650  (5.4542)
Week 5, Day 1 Number Analyzed 54 participants 52 participants 24 participants
1.248  (2.6737) 1.035  (1.0479) 2.946  (1.4428)
Week 13, Day 1 Number Analyzed 52 participants 50 participants 24 participants
1.137  (2.4242) 0.908  (0.8104) 4.625  (2.5594)
Week 25, Day 1 Number Analyzed 49 participants 48 participants 23 participants
1.090  (0.9932) 1.344  (0.9675) 5.043  (2.8221)
Week 49, Day 1 Number Analyzed 46 participants 42 participants 20 participants
1.802  (1.3956) 1.938  (1.2169) 5.145  (2.8201)
EOT Number Analyzed 31 participants 22 participants 2 participants
5.377  (4.1261) 5.691  (2.9528) 5.250  (3.0406)
Follow-Up Number Analyzed 15 participants 10 participants 1 participants
16.160  (11.0517) 14.610  (6.1553) 9.200  (0)
End of Study Number Analyzed 39 participants 28 participants 14 participants
11.441  (8.7613) 15.768  (12.3329) 5.943  (3.6185)
14.Secondary Outcome
Title Serum Sex Hormone-binding Globulin (SHBG) Concentrations
Hide Description Blood was collected and serum concentrations of SHBG were obtained using a validated laboratory test at a central laboratory facility.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Mean (Standard Deviation)
Unit of Measure: nanomoles per liter (nmol/L)
Week 2, Day 1 Number Analyzed 54 participants 51 participants 24 participants
50.811  (15.8822) 48.594  (17.7492) 39.029  (16.8910)
Week 5, Day 1 Number Analyzed 54 participants 54 participants 22 participants
49.641  (16.7048) 49.185  (21.1707) 43.786  (20.0484)
Week 13, Day 1 Number Analyzed 52 participants 52 participants 24 participants
49.210  (19.3704) 50.538  (23.2109) 41.858  (18.1416)
Week 25, Day 1 Number Analyzed 50 participants 50 participants 23 participants
47.998  (18.8690) 50.774  (23.3292) 40.839  (16.3732)
Week 49, Day 1 Number Analyzed 46 participants 41 participants 21 participants
50.607  (18.0377) 54.022  (26.1070) 38.237  (18.6708)
EOT Number Analyzed 31 participants 22 participants 1 participants
50.013  (21.5189) 54.105  (20.8439) 23.000  (0)
Follow-Up Number Analyzed 15 participants 10 participants 0 participants
45.433  (14.7416) 60.250  (28.1206)
End of Study Number Analyzed 39 participants 30 participants 14 participants
51.103  (17.8497) 51.063  (23.1018) 39.014  (13.1876)
15.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Mean (Standard Deviation)
Unit of Measure: score on a scale
Sexual Activity: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
-6.0  (29.25) -14.4  (22.39) -7.6  (20.25)
Sexual Activity: Week 13, Day 1 Number Analyzed 50 participants 51 participants 24 participants
-9.3  (18.49) -17.3  (27.28) -11.1  (19.45)
Sexual Activity: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
-9.4  (25.24) -19.8  (31.82) -18.8  (20.90)
Sexual Activity: Week 37, Day 1 Number Analyzed 46 participants 45 participants 21 participants
-12.0  (27.81) -14.4  (31.70) -14.3  (21.27)
Sexual Activity: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
-13.0  (28.40) -19.1  (36.24) -17.5  (31.39)
Sexual Activity: EOT Number Analyzed 35 participants 35 participants 13 participants
-15.7  (18.05) -18.1  (43.79) -30.8  (27.09)
Sexual Activity: Follow-up Number Analyzed 20 participants 29 participants 14 participants
-9.2  (18.32) -24.6  (32.09) -14.3  (34.50)
Sexual Activity: End of Study Number Analyzed 36 participants 29 participants 16 participants
-7.9  (25.04) -15.5  (35.89) -21.9  (24.13)
Sexual Functioning: Week 5, Day 1 Number Analyzed 21 participants 17 participants 12 participants
-9.9  (24.53) -2.0  (29.25) -4.2  (14.43)
Sexual Functioning: Week 13, Day 1 Number Analyzed 15 participants 12 participants 10 participants
-8.3  (20.89) -1.4  (29.27) 0.8  (27.34)
Sexual Functioning: Week 25, Day 1 Number Analyzed 16 participants 12 participants 7 participants
-4.7  (22.97) -12.5  (33.80) -16.7  (23.07)
Sexual Functioning: Week 37, Day 1 Number Analyzed 14 participants 13 participants 8 participants
-10.7  (18.90) -12.8  (17.55) -19.8  (17.22)
Sexual Functioning: Week 49, Day 1 Number Analyzed 12 participants 9 participants 7 participants
-16.7  (23.84) -13.9  (27.95) 6.0  (23.43)
Sexual Functioning: EOT Number Analyzed 8 participants 7 participants 2 participants
-16.7  (25.97) -10.7  (6.30) 37.5  (53.03)
Sexual Functioning: Follow-up Number Analyzed 8 participants 4 participants 4 participants
3.1  (21.33) -10.4  (18.48) 2.1  (73.40)
Sexual Functioning: End of Study Number Analyzed 13 participants 10 participants 3 participants
-11.5  (22.70) -4.2  (21.96) -13.9  (12.73)
Urinary Symptoms: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
2.0  (12.60) 1.8  (7.84) 4.2  (7.57)
Urinary Symptoms: Week 13, Day 1 Number Analyzed 50 participants 51 participants 24 participants
1.9  (11.64) 3.8  (7.54) 6.8  (10.70)
Urinary Symptoms: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
3.6  (15.46) 5.1  (12.28) 7.2  (10.60)
Urinary Symptoms: Week 37, Day 1 Number Analyzed 46 participants 45 participants 21 participants
3.4  (14.89) 4.2  (10.24) 12.9  (14.61)
Urinary Symptoms: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
4.0  (11.98) 6.5  (11.18) 9.9  (11.45)
Urinary Symptoms: EOT Number Analyzed 35 participants 35 participants 13 participants
3.3  (14.00) 7.1  (13.35) 9.0  (12.83)
Urinary Symptoms: Follow-up Number Analyzed 20 participants 19 participants 14 participants
-1.0  (11.30) 5.9  (14.52) 9.8  (7.42)
Urinary Symptoms: End of study Number Analyzed 36 participants 29 participants 16 participants
2.2  (10.84) 4.5  (14.04) 6.8  (13.08)
Bowel Symptoms: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
1.9  (7.24) 1.1  (6.81) 0.3  (5.75)
Bowel Symptoms: Week 13, Day 1 Number Analyzed 50 participants 51 participants 24 participants
1.0  (4.95) 1.8  (8.55) 2.4  (7.57)
Bowel Symptoms: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
3.1  (7.22) 0.3  (6.87) 1.1  (4.57)
Bowel Symptoms: Week 37, Day 1 Number Analyzed 46 participants 45 participants 21 participants
3.8  (7.80) 1.5  (7.60) 3.2  (7.21)
Bowel Symptoms: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
3.0  (6.44) 0.0  (6.97) 2.4  (7.04)
Bowel Symptoms: EOT Number Analyzed 35 participants 35 participants 13 participants
2.1  (6.18) 2.4  (7.98) 2.6  (6.26)
Bowel Symptoms: Follow-up Number Analyzed 20 participants 19 participants 14 participants
0.0  (4.68) 2.2  (9.95) 2.4  (8.91)
Bowel Symptoms: End of Study Number Analyzed 36 participants 29 participants 16 participants
2.1  (5.03) -0.3  (6.49) 1.0  (9.56)
HTRS: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
5.6  (8.98) 5.0  (8.03) 3.5  (8.94)
HTRS: Week 13, Day 1 Number Analyzed 50 participants 51 participants 24 participants
9.2  (9.95) 10.8  (10.80) 7.2  (9.48)
HTRS: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
11.7  (10.07) 11.3  (11.40) 10.9  (9.98)
HTRS: Week 37, Day 1 Number Analyzed 46 participants 45 participants 21 participants
13.3  (10.51) 12.2  (13.17) 13.2  (13.32)
HTRS: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
14.4  (12.39) 9.6  (11.04) 15.9  (12.82)
HTRS: EOT Number Analyzed 35 participants 35 participants 13 participants
12.9  (12.33) 14.0  (16.13) 17.9  (12.25)
HTRS: Follow-up Number Analyzed 20 participants 19 participants 14 participants
7.5  (8.51) 6.1  (9.05) 15.9  (15.69)
HTRS: End of Study Number Analyzed 36 participants 29 participants 16 participants
10.8  (11.03) 9.8  (11.27) 12.5  (12.75)
Incontinence Aid: Week 5, Day 1 Number Analyzed 20 participants 18 participants 4 participants
0.0  (21.63) -1.9  (17.98) -16.7  (19.25)
Incontinence Aid: Week 13, Day 1 Number Analyzed 19 participants 19 participants 4 participants
0.0  (22.22) -1.8  (13.49) -16.7  (19.25)
Incontinence Aid: Week 25, Day 1 Number Analyzed 19 participants 19 participants 2 participants
3.5  (21.93) 0.0  (15.71) -16.7  (23.57)
Incontinence Aid: Week 37, Day 1 Number Analyzed 16 participants 19 participants 2 participants
8.3  (25.82) -1.8  (13.49) -16.7  (23.57)
Incontinence Aid: Week 49, Day 1 Number Analyzed 19 participants 15 participants 3 participants
7.0  (23.78) -2.2  (15.26) -22.2  (19.25)
Incontinence Aid: EOT Number Analyzed 11 participants 11 participants 2 participants
6.1  (20.10) 6.1  (20.10) -16.7  (23.57)
Incontinence Aid: Follow-up Number Analyzed 6 participants 8 participants 1 participants
0.0  (21.08) -8.3  (15.43) -33.3  (0)
Incontinence Aid: End of Study Number Analyzed 12 participants 14 participants 1 participants
0.0  (20.10) -4.8  (22.10) -33.3  (0)
16.Secondary Outcome
Title Percent Change From Baseline of Aging Male Survey (AMS) Total Score
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Mean (Standard Deviation)
Unit of Measure: percent change
Week 5, Day 1 Number Analyzed 54 participants 52 participants 24 participants
3.914  (24.4749) 10.872  (29.6532) 10.083  (27.1933)
Week 13, Day 1 Number Analyzed 52 participants 51 participants 24 participants
14.781  (24.0185) 17.259  (33.9921) 21.887  (36.5551)
Week 25, Day 1 Number Analyzed 49 participants 48 participants 23 participants
20.272  (35.2952) 20.353  (34.2105) 46.995  (55.3558)
Week 37, Day 1 Number Analyzed 47 participants 46 participants 22 participants
24.136  (33.8595) 24.466  (35.6742) 49.422  (61.1264)
Week 49, Day 1 Number Analyzed 46 participants 41 participants 21 participants
30.122  (38.1093) 24.377  (33.6078) 59.971  (60.3579)
EOT Number Analyzed 36 participants 35 participants 13 participants
18.857  (37.9260) 28.644  (35.6470) 60.952  (63.3615)
Follow-Up Number Analyzed 20 participants 19 participants 14 participants
15.754  (21.8158) 13.031  (33.7754) 53.834  (61.6683)
End of Study Number Analyzed 37 participants 29 participants 16 participants
16.270  (24.2582) 21.304  (46.0184) 49.879  (54.1540)
17.Secondary Outcome
Title Change From Baseline in EORTC QLQ-C30
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description:
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.
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.
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Overall Number of Participants Analyzed 56 54 24
Mean (Standard Deviation)
Unit of Measure: score on a scale
Quality of Life: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
-2.7  (14.51) -4.0  (17.50) -5.2  (13.64)
Quality of Life: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
-2.3  (15.37) -2.0  (14.87) -7.3  (15.21)
Quality of Life: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
-6.4  (20.21) -2.3  (15.45) -6.9  (16.98)
Quality of Life: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
-6.0  (20.69) -7.4  (20.58) -11.7  (18.84)
Quality of Life: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
-7.2  (19.18) -7.3  (18.18) -8.3  (17.87)
Quality of Life: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
-3.4  (17.18) -12.0  (13.19)
Quality of Life: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
-6.6  (20.71) -2.2  (18.18)
Quality of Life: EOT Number Analyzed 35 participants 35 participants 13 participants
-4.8  (16.82) -7.1  (15.80) -13.5  (24.19)
Quality of Life: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
-5.4  (12.17) -8.8  (22.13) -13.7  (19.50)
Quality of Life: End of Study Number Analyzed 36 participants 29 participants 16 participants
-7.9  (18.14) -10.1  (15.49) -10.9  (13.85)
Physical Functioning: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
0.9  (9.87) -0.9  (7.70) -0.8  (8.41)
Physical Functioning: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
0.3  (9.23) -4.4  (8.50) -0.3  (14.77)
Physical Functioning: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
-2.8  (15.24) -5.3  (10.20) -2.0  (14.42)
Physical Functioning: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
-4.8  (13.60) -6.2  (12.26) -4.2  (16.78)
Physical Functioning: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
-4.3  (13.79) -5.2  (9.95) -7.0  (17.32)
Physical Functioning: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
-5.1  (9.20) -8.5  (8.72)
Physical Functioning: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
-8.1  (9.58) -6.0  (8.86)
Physical Functioning: EOT Number Analyzed 35 participants 35 participants 13 participants
-3.4  (15.37) -9.3  (14.66) -2.6  (22.20)
Physical Functioning: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
-4.0  (9.02) -6.3  (19.18) -3.8  (21.52)
Physical Functioning: End of Study Number Analyzed 36 participants 29 participants 16 participants
-8.9  (13.52) -9.0  (13.48) -2.9  (20.22)
Role Functioning: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
0.3  (14.43) -0.3  (15.30) 2.8  (8.03)
Role Functioning: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
-1.0  (17.13) -3.6  (16.09) 1.4  (21.93)
Role Functioning: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
-4.9  (21.18) -6.3  (19.03) -2.2  (23.19)
Role Functioning: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
-10.9  (23.10) -10.0  (16.82) -4.5  (24.22)
Role Functioning: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
-8.1  (23.20) -8.9  (22.70) -7.1  (19.42)
Role Functioning: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
-8.0  (13.08) -6.7  (14.43)
Role Functioning: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
-8.8  (15.08) -4.4  (12.22)
Role Functioning: EOT Number Analyzed 35 participants 35 participants 13 participants
-9.5  (21.88) -8.6  (20.76) -5.1  (29.17)
Role Functioning: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
-10.0  (16.58) -10.5  (31.04) -7.1  (29.75)
Role Functioning: End of Study Number Analyzed 36 participants 29 participants 16 participants
-10.6  (12.69) -13.2  (21.99) -1.0  (26.15)
Emotional Functioning: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
1.9  (8.59) 0.3  (12.45) 1.7  (10.98)
Emotional Functioning: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
-0.7  (11.53) -1.1  (12.70) -1.4  (12.69)
Emotional Functioning: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
-4.3  (12.26) -1.7  (11.73) -9.8  (20.35)
Emotional Functioning: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
-3.0  (14.01) -1.4  (12.06) -4.4  (18.56)
Emotional Functioning: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
-2.0  (9.36) -2.3  (16.578)
Emotional Functioning: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
-2.6  (12.44) 2.6  (7.88)
Emotional Functioning: EOT Number Analyzed 35 participants 35 participants 13 participants
-3.6  (11.30) -7.4  (17.12) -14.1  (24.15)
Emotional Functioning: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
-3.3  (8.72) -1.3  (19.50) -8.9  (23.22)
Emotional Functioning: End of Study Number Analyzed 36 participants 29 participants 16 participants
-5.3  (12.62) -0.6  (14.42) -8.3  (17.74)
Cognitive Functioning: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
-0.9  (11.97) -4.2  (14.71) -2.8  (10.62)
Cognitive Functioning: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
-1.0  (13.50) -7.5  (16.44) -5.6  (16.05)
Cognitive Functioning: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
-0.7  (14.16) -3.8  (15.08) -2.9  (11.95)
Cognitive Functioning: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
-5.8  (12.28) -5.6  (16.67) -9.8  (15.99)
Cognitive Functioning: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
-2.6  (12.29) -6.1  (13.82) -11.9  (16.79)
Cognitive Functioning: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
-5.7  (15.61) -7.3  (13.68)
Cognitive Functioning: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
-6.1  (8.26) -7.0  (13.96)
Cognitive Functioning: EOT Number Analyzed 20 participants 29 participants 14 participants
-2.9  (14.84) -10.0  (23.64) -12.8  (21.68)
Cognitive Functioning: Follow-Up Number Analyzed 20 participants 29 participants 14 participants
-0.8  (14.78) -7.0  (21.74) -10.7  (15.48)
Cognitive Functioning: End of Study Number Analyzed 36 participants 29 participants 16 participants
-2.3  (16.01) -7.5  (18.14) -3.1  (16.35)
Social Functioning: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
0.3  (16.50) -1.3  (14.33) 4.2  (16.48)
Social Functioning: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
1.6  (13.85) -3.3  (12.48) -0.7  (18.04)
Social Functioning: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
-1.0  (16.98) -6.3  (20.23) -202  (22.08)
Social Functioning: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
-2.5  (18.58) -5.9  (16.34) -7.6  (20.40)
Social Functioning: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
-3.7  (15.85) -9.8  (20.74) -8.7  (26.15)
Social Functioning: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
-2.9  (11.84) -6.0  (15.12)
Social Functioning: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
-5.3  (15.77) -4.4  (14.53)
Social Functioning: EOT Number Analyzed 35 participants 35 participants 13 participants
-5.2  (16.55) -10.0  (21.08) -6.4  (30.84)
Social Functioning: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
-3.3  (10.26) -8.8  (25.07) -4.8  (22.10)
Social Functioning: End of Study Number Analyzed 36 participants 29 participants 16 participants
-3.7  (16.48) -9.2  (19.20) 0.0  (14.91)
Fatigue: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
1.9  (13.74) 4.3  (14.95) 3.2  (15.19)
Fatigue: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
6.1  (17.40) 8.9  (15.72) 8.3  (11.47)
Fatigue: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
6.3  (21.12) 13.2  (15.66) 13.5  (18.94)
Fatigue: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
9.7  (21.55) 14.1  (19.30) 16.7  (21.89)
Fatigue: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
10.9  (24.33) 11.1  (16.67) 20.1  (23.47)
Fatigue: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
10.0  (24.19) 14.7  (13.88)
Fatigue: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
5.8  (22.94) 9.9  (18.48)
Fatigue: EOT Number Analyzed 35 participants 35 participants 13 participants
12.1  (27.53) 15.9  (20.22) 20.5  (18.62)
Fatigue: Follow-up Number Analyzed 20 participants 19 participants 14 participants
7.2  (15.41) 6.4  (19.71) 13.5  (21.87)
Fatigue: End of study Number Analyzed 36 participants 29 participants 16 participants
11.4  (17.72) 12.3  (22.88) 8.3  (19.25)
Nausea and Vomiting: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
-1.3  (6.41) 0.6  (9.88) 3.5  (6.91)
Nausea and Vomiting: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
0.7  (7.42) 0.7  (7.42) 1.4  (4.71)
Nausea and Vomiting: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
0.0  (9.10) 0.0  (3.44) 2.9  (6.46)
Nausea and Vomiting: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
0.4  (8.95) 1.1  (7.45) 4.5  (9.17)
Nausea and Vomiting: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
-1.9  (7.30) 0.8  (6.40) 4.8  (11.95)
Nausea and Vomiting: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
0.0  (4.45) 0.7  (3.33)
Nausea and Vomiting: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
5.3  (14.75) 1.8  (9.45)
Nausea and Vomiting: Week EOT Number Analyzed 35 participants 35 participants 13 participants
-0.5  (8.56) 1.9  (8.83) 7.7  (14.62)
Nausea and Vomiting: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
3.3  (16.75) 0.9  (3.82) 0.0  (6.54)
Nausea and Vomiting: End of Study Number Analyzed 36 participants 29 participants 16 participants
1.4  (9.24) -1.1  (4.30) 0.0  (6.09)
Pain: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
-1.6  (16.75) 0.6  (16.82) 3.5  (18.38)
Pain: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
-1.0  (17.77) 3.3  (18.86) 4.2  (26.12)
Pain: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
0.3  (22.67) 2.8  (16.61) 2.9  (22.84)
Pain: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
2.9  (23.65) 5.9  (21.37) 11.4  (34.27)
Pain: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
3.3  (23.19) 6.5  (18.59) 7.9  (31.46)
Pain: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
6.9  (18.64) 7.3  (14.50)
Pain: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
5.3  (19.29) 0.0  (14.70)
Pain: EOT Number Analyzed 35 participants 35 participants 13 participants
-0.5  (25.08) 6.7  (24.32) 6.4  (35.05)
Pain: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
9.2  (21.95) 10.5  (23.05) 1.2  (28.84)
Pain: End of Study Number Analyzed 36 participants 29 participants 16 participants
6.5  (17.03) 6.9  (19.17) -2.1  (30.96)
Dyspnea: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
-0.6  (21.17) 2.6  (17.27) 5.6  (18.82)
Dyspnea: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
5.9  (22.81) 6.5  (21.10) 8.3  (20.26)
Dyspnea: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
4.2  (26.30) 8.3  (22.28) 8.7  (22.96)
Dyspnea: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
6.5  (21.80) 11.1  (22.47) 22.7  (26.00)
Dyspnea: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
6.7  (22.02) 9.8  (20.06) 17.5  (30.95)
Dyspnea: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
8.0  (19.22) 9.3  (18.05)
Dyspnea: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
10.5  (19.41) 8.8  (18.73)
Dyspnea: EOT Number Analyzed 35 participants 35 participants 13 participants
7.6  (24.37) 14.3  (20.27) 20.5  (32.03)
Dyspnea: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
11.7  (22.36) 8.8  (26.86) 14.3  (25.20)
Dyspnea: End of Study Number Analyzed 36 participants 29 participants 16 participants
11.1  (19.52) 14.9  (26.10) 8.3  (31.03)
Insomnia: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
-1.3  (24.43) 3.2  (17.79) 1.4  (18.33)
Insomnia: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
2.6  (20.92) 9.8  (21.39) 6.9  (19.61)
Insomnia: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
6.3  (30.49) 12.5  (24.43) 8.7  (22.96)
Insomnia: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
2.2  (24.75) 8.1  (22.65) 18.2  (32.08)
Insomnia: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
6.7  (29.81) 7.3  (22.99) 6.3  (32.69)
Insomnia: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
2.3  (33.25) 10.7  (23.01)
Insomnia: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
10.5  (27.34) 10.5  (19.41)
Insomnia: EOT Number Analyzed 35 participants 35 participants 13 participants
6.7  (35.97) 7.6  (26.92) 7.7  (24.17)
Insomnia: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
5.0  (19.57) 0.0  (27.22) 4.8  (25.68)
Insomnia: End of Study Number Analyzed 36 participants 29 participants 16 participants
1.9  (28.67) 5.7  (21.95) 10.4  (29.11)
Appetite Loss: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
-3.8  (14.11) 0.6  (21.38) 2.8  (13.61)
Appetite Loss: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
-0.7  (18.25) -0.7  (20.54) 0.0  (13.90)
Appetite Loss: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
-3.5  (19.74) 0.0  (19.45) 2.9  (17.15)
Appetite Loss: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
-0.7  (17.90) 2.2  (16.51) 0.0  (14.55)
Appetite Loss: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
-0.7  (16.65) 0.8  (15.79) 4.8  (15.94)
Appetite Loss: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
-2.3  (12.38) 5.3  (18.46)
Appetite Loss: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
0.0  (15.71) 3.5  (15.29)
Appetite Loss: EOT Number Analyzed 35 participants 35 participants 13 participants
-3.8  (15.70) 8.6  (16.85) 2.6  (16.45)
Appetite Loss: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
0.0  (15.29) 3.5  (18.90) -2.4  (15.82)
Appetite Loss: End of Study Number Analyzed 36 participants 29 participants 16 participants
-1.9  (13.67) 3.4  (13.64) 0.0  (24.34)
Constipation: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
0.6  (20.14) 1.9  (17.97) 1.4  (6.80)
Constipation: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
3.9  (21.75) 5.2  (19.29) 5.6  (12.69)
Constipation: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
2.8  (19.25) 6.3  (25.41) 1.4  (15.82)
Constipation: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
5.8  (20.25) 8.1  (26.74) 1.5  (12.50)
Constipation: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
2.2  (19.33) 7.3  (20.43) 1.6  (7.27)
Constipation: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
1.1  (18.86) 1.3  (17.95)
Constipation: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
1.8  (26.00) 3.5  (21.93)
Constipation: EOT Number Analyzed 35 participants 35 participants 13 participants
3.8  (22.54) 1.9  (17.97) 0.0  (13.61)
Constipation: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
5.0  (24.84) 10.5  (24.98) 0.0  (13.07)
Constipation: End Of Study Number Analyzed 36 participants 29 participants 16 participants
3.7  (19.15) 5.7  (17.97) 0.0  (17.21)
Diarrhea: Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
-1.9  (12.08) 1.9  (13.87) 1.4  (11.95)
Diarrhea: Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
3.9  (18.44) 2.0  (23.49) 0.0  (9.83)
Diarrhea: Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
2.8  (17.97) 5.6  (19.85) 2.9  (13.90)
Diarrhea: Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
3.6  (17.54) 0.7  (15.06) 6.1  (13.16)
Diarrhea: Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
3.0  (17.15) -1.6  (16.59) 1.6  (16.59)
Diarrhea: Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
4.6  (17.19) 1.3  (15.15)
Diarrhea: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
7.0  (17.84) 0.0  (15.71)
Diarrhea: EOT Number Analyzed 35 participants 35 participants 13 participants
4.8  (14.33) 2.9  (16.90) 5.1  (18.49)
Diarrhea: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
3.3  (10.26) 0.0  (19.25) 4.8  (12.10)
Diarrhea: End Of Study Number Analyzed 36 participants 29 participants 16 participants
1.9  (17.72) -1.1  (18.86) 2.1  (19.12)
Financial Difficulties:Week 5, Day 1 Number Analyzed 53 participants 52 participants 24 participants
-1.3  (9.16) 2.6  (21.74) -1.4  (18.33)
Financial Difficulties:Week 13, Day 1 Number Analyzed 51 participants 51 participants 24 participants
-2.0  (16.88) -0.7  (20.54) 2.8  (23.91)
Financial Difficulties:Week 25, Day 1 Number Analyzed 48 participants 48 participants 23 participants
-3.5  (12.38) 0.7  (20.03) 4.3  (23.15)
Financial Difficulties:Week 37, Day 1 Number Analyzed 46 participants 45 participants 22 participants
-2.9  (19.66) 1.5  (18.74) 7.6  (20.40)
Financial Difficulties:Week 49, Day 1 Number Analyzed 45 participants 41 participants 21 participants
-5.2  (20.04) 0.8  (18.99) 3.2  (17.97)
Financial Difficulties:Week 73, Day 1 Number Analyzed 29 participants 25 participants 0 participants
0.0  (8.91) 2.7  (16.44)
Financial Difficulties: Week 97, Day 1 Number Analyzed 19 participants 19 participants 0 participants
5.3  (20.07) 1.8  (20.71)
Financial Difficulties: EOT Number Analyzed 35 participants 35 participants 13 participants
-3.8  (19.42) 5.7  (20.59) 2.6  (16.45)
Financial Difficulties: Follow-Up Number Analyzed 20 participants 19 participants 14 participants
5.0  (12.21) 1.8  (20.71) 11.9  (33.61)
Financial Difficulties: End of Study Number Analyzed 36 participants 29 participants 16 participants
-2.8  (18.47) 3.4  (22.44) 0.0  (21.08)
Time Frame From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Adverse Event Reporting Description Safety population included all randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Hide Arm/Group Description 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. 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. Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
All-Cause Mortality
Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/56 (17.86%)   7/54 (12.96%)   2/24 (8.33%) 
Cardiac disorders       
Bradycardia  1  2/56 (3.57%)  0/54 (0.00%)  0/24 (0.00%) 
Tachycardia  1  0/56 (0.00%)  1/54 (1.85%)  0/24 (0.00%) 
Acute coronary syndrome  1  0/56 (0.00%)  1/54 (1.85%)  0/24 (0.00%) 
Myocardial infarction  1 [1]  0/56 (0.00%)  0/54 (0.00%)  1/24 (4.17%) 
Atrioventricular block first degree  1  1/56 (1.79%)  0/54 (0.00%)  0/24 (0.00%) 
Atrial flutter  1  0/56 (0.00%)  1/54 (1.85%)  0/24 (0.00%) 
Cardiac arrest  1 [2]  1/56 (1.79%)  0/54 (0.00%)  0/24 (0.00%) 
Gastrointestinal disorders       
Intestinal obstruction  1  1/56 (1.79%)  0/54 (0.00%)  0/24 (0.00%) 
General disorders       
Death  1 [3]  0/56 (0.00%)  1/54 (1.85%)  0/24 (0.00%) 
Sudden death  1 [3]  0/56 (0.00%)  1/54 (1.85%)  0/24 (0.00%) 
Infections and infestations       
Sepsis  1  1/56 (1.79%)  0/54 (0.00%)  0/24 (0.00%) 
Urinary tract infection  1  1/56 (1.79%)  0/54 (0.00%)  0/24 (0.00%) 
Injury, poisoning and procedural complications       
Cervical vertebral fracture  1  1/56 (1.79%)  0/54 (0.00%)  0/24 (0.00%) 
Metabolism and nutrition disorders       
Hypercalcaemia  1  0/56 (0.00%)  1/54 (1.85%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis  1  0/56 (0.00%)  1/54 (1.85%)  0/24 (0.00%) 
Nervous system disorders       
Cerebral haemorrhage  1 [4]  1/56 (1.79%)  0/54 (0.00%)  0/24 (0.00%) 
Cerebrovascular accident  1  1/56 (1.79%)  0/54 (0.00%)  0/24 (0.00%) 
Embolic stroke  1  0/56 (0.00%)  1/54 (1.85%)  0/24 (0.00%) 
Syncope  1  1/56 (1.79%)  0/54 (0.00%)  0/24 (0.00%) 
Transient ischaemic attack  1  1/56 (1.79%)  0/54 (0.00%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/56 (1.79%)  0/54 (0.00%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
[1]
One treatment-emergent death occurred during treatment with leuprorelin 22.5 mg and is not related.
[2]
One treatment-emergent death occurred during treatment with relugolix 80 mg and is not related.
[3]
One treatment-emergent death occurred during treatment with relugolix 120 mg and is not related.
[4]
One treatment-emergent death occurred during treatment with relugolix 80 mg is not related.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Relugolix 80 mg Relugolix 120 mg Leuprorelin 22.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   53/56 (94.64%)   50/54 (92.59%)   23/24 (95.83%) 
Congenital, familial and genetic disorders       
Corneal dystrophy  1  3/56 (5.36%)  0/54 (0.00%)  0/24 (0.00%) 
Eye disorders       
Cataract  1  7/56 (12.50%)  13/54 (24.07%)  0/24 (0.00%) 
Visual acuity reduced  1  2/56 (3.57%)  4/54 (7.41%)  0/24 (0.00%) 
Dry eye  1  3/56 (5.36%)  0/54 (0.00%)  0/24 (0.00%) 
Gastrointestinal disorders       
Constipation  1  2/56 (3.57%)  5/54 (9.26%)  0/24 (0.00%) 
Diarrhoea  1  3/56 (5.36%)  3/54 (5.56%)  0/24 (0.00%) 
Nausea  1  1/56 (1.79%)  4/54 (7.41%)  0/24 (0.00%) 
General disorders       
Fatigue  1  11/56 (19.64%)  19/54 (35.19%)  7/24 (29.17%) 
Pyrexia  1  3/56 (5.36%)  0/54 (0.00%)  0/24 (0.00%) 
Infections and infestations       
Nasopharyngitis  1  4/56 (7.14%)  5/54 (9.26%)  1/24 (4.17%) 
Urinary tract infection  1  5/56 (8.93%)  2/54 (3.70%)  1/24 (4.17%) 
Sinusitis  1  3/56 (5.36%)  2/54 (3.70%)  1/24 (4.17%) 
Gastroenteritis viral  1  0/56 (0.00%)  3/54 (5.56%)  0/24 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  4/56 (7.14%)  2/54 (3.70%)  1/24 (4.17%) 
Contusion  1  0/56 (0.00%)  3/54 (5.56%)  0/24 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  7/56 (12.50%)  3/54 (5.56%)  4/24 (16.67%) 
Aspartate aminotransferase increased  1  6/56 (10.71%)  1/54 (1.85%)  3/24 (12.50%) 
Gamma-glutamyltransferase increased  1  3/56 (5.36%)  1/54 (1.85%)  2/24 (8.33%) 
Weight increased  1  4/56 (7.14%)  2/54 (3.70%)  0/24 (0.00%) 
Blood triglycerides increased  1  3/56 (5.36%)  0/54 (0.00%)  1/24 (4.17%) 
Weight decreased  1  1/56 (1.79%)  0/54 (0.00%)  2/24 (8.33%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  1/56 (1.79%)  1/54 (1.85%)  3/24 (12.50%) 
Hypercholesterolaemia  1  3/56 (5.36%)  0/54 (0.00%)  2/24 (8.33%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  9/56 (16.07%)  6/54 (11.11%)  2/24 (8.33%) 
Back pain  1  3/56 (5.36%)  2/54 (3.70%)  1/24 (4.17%) 
Osteopenia  1  3/56 (5.36%)  3/54 (5.56%)  0/24 (0.00%) 
Pain in extremity  1  4/56 (7.14%)  2/54 (3.70%)  0/24 (0.00%) 
Musculoskeletal pain  1  0/56 (0.00%)  4/54 (7.41%)  0/24 (0.00%) 
Muscle spasms  1  1/56 (1.79%)  0/54 (0.00%)  2/24 (8.33%) 
Myalgia  1  0/56 (0.00%)  0/54 (0.00%)  3/24 (12.50%) 
Nervous system disorders       
Dizziness  1  2/56 (3.57%)  4/54 (7.41%)  0/24 (0.00%) 
Headache  1  2/56 (3.57%)  3/54 (5.56%)  1/24 (4.17%) 
Psychiatric disorders       
Insomnia  1  1/56 (1.79%)  5/54 (9.26%)  2/24 (8.33%) 
Libido decreased  1  1/56 (1.79%)  3/54 (5.56%)  1/24 (4.17%) 
Depression  1  1/56 (1.79%)  3/54 (5.56%)  0/24 (0.00%) 
Renal and urinary disorders       
Pollakiuria  1  2/56 (3.57%)  0/54 (0.00%)  3/24 (12.50%) 
Reproductive system and breast disorders       
Gynaecomastia  1  3/56 (5.36%)  3/54 (5.56%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/56 (5.36%)  4/54 (7.41%)  1/24 (4.17%) 
Nasal congestion  1  1/56 (1.79%)  2/54 (3.70%)  2/24 (8.33%) 
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  2/56 (3.57%)  1/54 (1.85%)  3/24 (12.50%) 
Vascular disorders       
Hot flush  1  32/56 (57.14%)  35/54 (64.81%)  15/24 (62.50%) 
Hypertension  1  1/56 (1.79%)  4/54 (7.41%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT02083185     History of Changes
Other Study ID Numbers: C27002
U1111-1162-5028 ( Registry Identifier: WHO )
172837 ( Registry Identifier: HC-CTD )
First Submitted: March 6, 2014
First Posted: March 11, 2014
Results First Submitted: February 1, 2018
Results First Posted: May 9, 2018
Last Update Posted: May 9, 2018