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A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer (HERO)

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: NCT03085095
Recruitment Status : Completed
First Posted : March 21, 2017
Results First Posted : March 25, 2021
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

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: Leuprolide Acetate
Enrollment 1134
Recruitment Details To support registration in China, the study continued to enroll additional nonmetastatic or metastatic participants from China after the final analysis to reach the target enrollment of approximately 90 participants.
Pre-assignment Details The primary analysis of efficacy and safety included 934 participants. The primary analysis excluded additional participants with metastatic disease and a cohort of participants enrolled in China and Taiwan who will be included in the final analysis of the study (N=200).
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description Relugolix 120-milligram (mg) tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1. Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Period Title: Overall Study
Started 624 310
Received at Least 1 Dose of Study Drug [1] 622 308
Completed [2] 563 276
Not Completed 61 34
Reason Not Completed
Adverse Event             23             8
Protocol Violation             0             1
Lost to Follow-up             2             1
Withdrawal by Subject             17             6
Physician Decision             9             3
Testosterone Suppression Level Not Met             7             13
Did not Receive Study Drug             2             2
Dosing Interruption (Logistical Reason)             1             0
[1]
Four participants (2 in each treatment group) were randomized but did not receive study drug.
[2]
Completed 48 weeks of treatment.
Arm/Group Title Relugolix Leuprolide Acetate Total
Hide Arm/Group Description Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1. Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection. Total of all reporting groups
Overall Number of Baseline Participants 622 308 930
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 622 participants 308 participants 930 participants
71.2  (7.75) 71.0  (8.03) 71.1  (7.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 622 participants 308 participants 930 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
622
 100.0%
308
 100.0%
930
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 622 participants 308 participants 930 participants
Hispanic or Latino
52
   8.4%
31
  10.1%
83
   8.9%
Not Hispanic or Latino
558
  89.7%
269
  87.3%
827
  88.9%
Unknown or Not Reported
12
   1.9%
8
   2.6%
20
   2.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 622 participants 308 participants 930 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
127
  20.4%
71
  23.1%
198
  21.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
30
   4.8%
16
   5.2%
46
   4.9%
White
434
  69.8%
202
  65.6%
636
  68.4%
More than one race
11
   1.8%
4
   1.3%
15
   1.6%
Unknown or Not Reported
20
   3.2%
15
   4.9%
35
   3.8%
1.Primary Outcome
Title Sustained Castration Rate
Hide Description

Sustained castration rate defined as the cumulative probability of testosterone suppression to < 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.

The lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy.
Time Frame From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.7
(94.9 to 97.9)
88.8
(84.6 to 91.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix, Leuprolide Acetate
Comments Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of non-inferiority was conducted.
Type of Statistical Test Non-Inferiority
Comments The lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups was calculated with a noninferiority margin of -10%.
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
4.1 to 11.8
Estimation Comments Treatment difference= Relugolix - Leuprolide acetate
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relugolix, Leuprolide Acetate
Comments Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of superiority was conducted.
Type of Statistical Test Superiority
Comments If non-inferiority was demonstrated, superiority could be claimed if the lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups also excluded 0%. The p value was calculated post hoc.
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments Two-sided type I error of 0.05.
2.Secondary Outcome
Title Castration Rate At Week 1 Day 4
Hide Description Castration rate was defined as the cumulative probability of testosterone suppression to < 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time Frame Week 1 Day 4 (Day 4)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56.04
(52.18 to 59.97)
0.00 [1] 
(NA to NA)
[1]
Not estimable due to insufficient number of participants with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix, Leuprolide Acetate
Comments Alpha-protected statistical analysis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Statistically significance was met if p-value < 0.05.
Method t-test, 2 sided
Comments Two-sided type I error rate of 0.05.
3.Secondary Outcome
Title Castration Rate At Week 3 Day 1
Hide Description Castration rate was defined as the cumulative probability of testosterone suppression to < 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time Frame Week 3 Day 1 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.71
(97.56 to 99.39)
12.05
(8.88 to 16.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix, Leuprolide Acetate
Comments Alpha-protected statistical analysis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Statistically significance was met if p-value < 0.05.
Method t-test, 2 sided
Comments Two-sided type I error rate of 0.05.
4.Secondary Outcome
Title Confirmed Prostate-specific Antigen (PSA) Response Rate
Hide Description Confirmed PSA response defined as > 50% reduction in PSA from baseline at Week 3 Day 1 followed with confirmation at Week 5 Day 1.
Time Frame Week 3 Day 1 (Day 15) and Week 5 Day 1 (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
79.4
(76.03 to 82.53)
19.8
(15.50 to 24.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix, Leuprolide Acetate
Comments Alpha-protected statistical analysis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Statistically significance was met if p-value < 0.05.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Profound Castration Rate At Week 3 Day 1 (Day 15)
Hide Description Castration rate defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time Frame Week 3 Day 1 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.38
(75.06 to 81.53)
0.98
(0.32 to 3.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix, Leuprolide Acetate
Comments Alpha-protected statistical analysis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Statistically significance was met if p-value < 0.05.
Method t-test, 2 sided
Comments Two-sided type I error rate of 0.05.
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 77.41
Confidence Interval (2-Sided) 95%
73.98 to 80.83
Estimation Comments Treatment difference= Relugolix - Leuprolide acetate
6.Secondary Outcome
Title Follicle-stimulating Hormone (FSH) Level
Hide Description To evaluate the effect of relugolix and leuprolide acetate on FSH suppression.
Time Frame Week 25 Day 1 (Day 169)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Mean (Standard Deviation)
Unit of Measure: IU/L
1.72  (1.376) 5.95  (3.071)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix, Leuprolide Acetate
Comments Alpha-protected statistical analysis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Statistically significance was met if p-value < 0.05.
Method t-test, 2 sided
Comments Two-sided type I error rate of 0.05.
7.Secondary Outcome
Title PSA Response Rate At Week 3 Day 1
Hide Description PSA response defined as > 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time Frame Week 3 Day 1 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.1
(76.70 to 83.14)
20.1
(15.80 to 25.05)
8.Secondary Outcome
Title PSA Response Rate At Week 5 Day 1
Hide Description PSA response defined as > 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time Frame Week 5 Day 1 (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.5
(92.44 to 96.19)
79.2
(74.26 to 83.61)
9.Secondary Outcome
Title Testosterone Recovery Rate
Hide Description The cumulative probability of testosterone recovery back to > 280 ng/dL (lower limit of the normal range), back to ≥ 50 ng/dL (definition of castration), and back to > 280 ng/dL or baseline at 90 days after drug discontinuation was assessed. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time Frame Day 90 follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and were followed in the testosterone recovery phase.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
≥ 50 ng/dL
93.01
(87.82 to 96.54)
10.12
(3.84 to 25.24)
> 280 ng/dL
53.93
(45.20 to 63.16)
3.23
(0.46 to 20.77)
> Baseline level or 280 ng/dL
54.73
(45.97 to 63.94)
3.23
(0.46 to 20.77)
10.Secondary Outcome
Title Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1
Hide Description Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.
Time Frame Week 5 Day 1 (Day 29) through Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.6
(78.1 to 84.5)
68.6
(63.0 to 73.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix, Leuprolide Acetate
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
6.9 to 19.1
Estimation Comments Treatment difference= Relugolix - Leuprolide acetate
11.Secondary Outcome
Title Profound Castration Rate At Week 1 Day 4 (Day 4)
Hide Description Castration rate defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time Frame At Week 1 Day 4 (Day 4)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.92
(5.18 to 9.22)
0.0 [1] 
(NA to NA)
[1]
Not estimable due to insufficient number of participants with events.
12.Secondary Outcome
Title Sustained Profound Castration Rate From Week 25 Day 1 Through Week 49 Day 1
Hide Description Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to < 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.
Time Frame Week 25 Day 1 (Day 169) through Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.6
(81.3 to 87.3)
87.5
(83.0 to 90.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix, Leuprolide Acetate
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-7.8 to 2.0
Estimation Comments Treatment difference= Relugolix - Leuprolide acetate
13.Secondary Outcome
Title Undetectable PSA Rate
Hide Description Defined as the proportion of participants with PSA concentration < 0.02 ng/milliliter (mL).The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.
Time Frame Week 25 Day 1 (Day 169)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.7
(17.62 to 24.14)
20.8
(16.39 to 25.74)
14.Secondary Outcome
Title Rate Of PSA Progression-free Survival
Hide Description PSA progression was defined as the first increase in PSA of 25% or greater and 2 ng/mL or greater above the nadir with confirmation by a second consecutive PSA measurement at least 3 weeks later. For participants without declining PSA from baseline, a PSA increase of ≥ 25% and ≥ 2 ng/mL from baseline beyond 12 weeks was considered PSA progression. The rate of progression-free survival was estimated using the Kaplan-Meier method and reported as percentage of participants.
Time Frame Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89.31
(86.52 to 91.55)
89.50
(85.39 to 92.50)
15.Secondary Outcome
Title Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organisation Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30
Hide Description The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. The global health and quality of life domain is presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
Time Frame Baseline, Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 543 257
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.8  (18.13) -3.6  (15.70)
16.Secondary Outcome
Title Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-C30
Hide Description The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. All domains except for the global health and quality are presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
Time Frame Baseline, Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 543 257
Mean (Standard Deviation)
Unit of Measure: score on a scale
Physical functioning -4.6  (13.09) -4.4  (12.29)
Role functioning -6.2  (19.92) -5.6  (17.84)
Emotional functioning 0.5  (16.12) -0.5  (13.23)
Cognitive functioning -3.7  (16.77) -3.8  (16.37)
Social functioning -2.7  (18.31) -4.0  (18.18)
Fatigue 6.1  (19.46) 7.0  (18.40)
Nausea and vomiting 0.2  (7.12) 0.8  (6.02)
Pain 1.7  (20.19) 4.0  (21.96)
Dyspnoea 5.3  (19.16) 7.9  (20.25)
Insomnia 4.8  (25.88) 4.8  (21.82)
Appetite loss -0.6  (17.82) -0.6  (14.86)
Constipation 1.4  (23.26) 3.5  (18.88)
Diarrhoea 2.0  (16.70) 1.4  (19.60)
Financial difficulties 0.2  (18.28) 0.1  (19.21)
17.Secondary Outcome
Title Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains
Hide Description Subscales for assessment of hormonal treatment-related symptoms (6 items) and sexual activity and function (6 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
Time Frame Baseline, Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 537 256
Mean (Standard Deviation)
Unit of Measure: score on a scale
Sexual activity 13.9  (26.51) 10.8  (27.90)
Sexual functioning -9.0  (23.37) -10.4  (21.10)
Hormonal treatment-related symptoms 10.6  (12.25) 11.4  (13.30)
18.Secondary Outcome
Title Change From Baseline In QoL Total Score For Urinary And Bowel Symptoms Domains As Assessed By The EORTC-QLQ-PR25
Hide Description Subscale assessments of urinary symptoms (9 items) and bowel symptoms (4 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. A decrease in symptom scores indicates improvement (lower level of symptoms/problems).
Time Frame Baseline, Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 537 256
Mean (Standard Deviation)
Unit of Measure: score on a scale
Urinary symptoms 1.1  (15.29) -0.4  (13.78)
Incontinence aid use 1.0  (15.41) 0.0  (19.80)
Bowel symptoms 1.2  (8.92) 2.0  (9.51)
19.Secondary Outcome
Title Change From Baseline In QoL Total Score As Assessed By The European Quality Of Life 5-Dimension 5-Level Questionnaire (EuroQoL EQ-5D-5L)
Hide Description The EuroQoL EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems (1 as numerical score), slight problems (2 as numerical score), moderate problems (3 as numerical score), severe problems (4 as numerical score), and extreme problems (5 as numerical score). The total score ranges from 0 to 100. A decrease in score indicates improvement.
Time Frame Baseline, Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 549 259
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.5  (14.36) -2.7  (14.57)
20.Secondary Outcome
Title Percent Change From Baseline In Serum Concentrations Of Luteinizing Hormone
Hide Description Blood samples were collected from participants for hormonal measurements.
Time Frame Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 1 Day 4 (Day 4) -88.25  (20.696) 147.71  (122.735)
Week 5 Day 1 (Day 29) -94.54  (8.500) -82.67  (27.146)
Week 25 Day 1 (Day 169) -93.93  (7.242) -93.45  (13.202)
Week 49 Day 1 (Day 337) -91.54  (16.779) -95.14  (4.507)
21.Secondary Outcome
Title Percent Change From Baseline In Serum Concentrations Of FSH
Hide Description Blood samples were collected from participants for hormonal measurements.
Time Frame Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Mean (Standard Deviation)
Unit of Measure: percent change
Week 1 Day 4 (Day 4) -62.59  (9.051) -4.74  (36.121)
Week 5 Day 1 (Day 29) -90.80  (8.151) -67.73  (27.311)
Week 25 Day 1 (Day 169) -86.32  (10.699) -47.53  (32.560)
Week 49 Day 1 (Day 337) -79.39  (21.987) -47.23  (30.112)
22.Secondary Outcome
Title Percent Change From Baseline In Serum Concentrations Of Dihydrotestosterone
Hide Description Blood samples were collected from participants for hormonal measurements.
Time Frame Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Mean (Standard Deviation)
Unit of Measure: percent change
Week 5 Day 1 (Day 29) -87.61  (12.225) -81.95  (23.733)
Week 25 Day 1 (Day 169) -88.06  (11.810) -85.45  (32.261)
Week 49 Day 1 (Day 337) -88.23  (11.235) -87.56  (12.088)
23.Secondary Outcome
Title Percent Change From Baseline In Serum Concentrations Of Sex Hormone-Binding Globulin
Hide Description Blood samples were collected from participants for hormonal measurements.
Time Frame Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Mean (Standard Deviation)
Unit of Measure: percent change
Week 5 Day 1 (Day 29) 1.08  (22.068) -1.21  (20.430)
Week 25 Day 1 (Day 169) 7.24  (28.265) 3.59  (24.947)
Week 49 Day 1 (Day 337) 6.54  (28.787) 2.59  (27.051)
24.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) Of Relugolix
Hide Description The Cmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose pharmacokinetics (PK) was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
Time Frame Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of Japanese participants enrolled in study were included in the PK analysis.
Arm/Group Title Relugolix Single-Dose Relugolix Repeat-Dose
Hide Arm/Group Description:
Relugolix oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Relugolix 120-mg tablet administered orally once daily for 2 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
125
(220%)
46.4
(141%)
25.Secondary Outcome
Title Area Under The Concentration-Time Curve (AUC0-τ) Of Relugolix
Hide Description The AUC0-τ of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
Time Frame Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of Japanese participants enrolled in study were included in the PK analysis.
Arm/Group Title Relugolix Single-Dose Relugolix Repeat-Dose
Hide Arm/Group Description:
Relugolix oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Relugolix 120-mg tablet administered orally once daily for 2 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng⸳hr/mL
663
(151%)
373
(51%)
26.Secondary Outcome
Title Time To Maximum Observed Plasma Concentration (Tmax) Of Relugolix
Hide Description The Tmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
Time Frame Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of Japanese participants enrolled in study were included in the PK analysis.
Arm/Group Title Relugolix Single-Dose Relugolix Repeat-Dose
Hide Arm/Group Description:
Relugolix oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Relugolix 120-mg tablet administered orally once daily for 2 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Overall Number of Participants Analyzed 7 7
Median (Full Range)
Unit of Measure: hours
1.03
(0.400 to 4.05)
0.983
(0.433 to 4.08)
27.Other Pre-specified Outcome
Title Percentage of Participants Who Experienced Major Adverse Cardiovascular Events (MACE)
Hide Description MACE were defined as nonfatal myocardial infarction, nonfatal stroke, and death from any cause.
Time Frame From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description:
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
Overall Number of Participants Analyzed 622 308
Measure Type: Number
Unit of Measure: percentage of participants
2.9 6.2
Time Frame Day 1 (after dosing) through up to 52 weeks
Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.
 
Arm/Group Title Relugolix Leuprolide Acetate
Hide Arm/Group Description Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1. Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, and Taiwan), every 3 months by subcutaneous injection.
All-Cause Mortality
Relugolix Leuprolide Acetate
Affected / at Risk (%) Affected / at Risk (%)
Total   7/622 (1.13%)   9/308 (2.92%) 
Hide Serious Adverse Events
Relugolix Leuprolide Acetate
Affected / at Risk (%) Affected / at Risk (%)
Total   76/622 (12.22%)   47/308 (15.26%) 
Blood and lymphatic system disorders     
Anaemia † 1  0/622 (0.00%)  3/308 (0.97%) 
Pancytopenia † 1  0/622 (0.00%)  1/308 (0.32%) 
Cardiac disorders     
Acute myocardial infarction † 1  5/622 (0.80%)  1/308 (0.32%) 
Atrial fibrillation † 1  2/622 (0.32%)  1/308 (0.32%) 
Acute coronary syndrome † 1  1/622 (0.16%)  0/308 (0.00%) 
Acute left ventricular failure † 1  1/622 (0.16%)  1/308 (0.32%) 
Aortic valve stenosis † 1  1/622 (0.16%)  0/308 (0.00%) 
Atrioventricular block complete † 1  1/622 (0.16%)  0/308 (0.00%) 
Atrioventricular block second degree † 1  1/622 (0.16%)  0/308 (0.00%) 
Cardiac failure † 1  1/622 (0.16%)  1/308 (0.32%) 
Cardiac failure congestive † 1  1/622 (0.16%)  1/308 (0.32%) 
Angina unstable † 1  0/622 (0.00%)  1/308 (0.32%) 
Cardiac failure acute † 1  0/622 (0.00%)  1/308 (0.32%) 
Cardio-respiratory arrest † 1  0/622 (0.00%)  3/308 (0.97%) 
Cardiopulmonary failure † 1  0/622 (0.00%)  1/308 (0.32%) 
Sinus arrest † 1  0/622 (0.00%)  1/308 (0.32%) 
Sinus node dysfunction † 1  0/622 (0.00%)  1/308 (0.32%) 
Ear and labyrinth disorders     
Vertigo † 1  1/622 (0.16%)  1/308 (0.32%) 
Endocrine disorders     
Hypercalcaemia of malignancy † 1  0/622 (0.00%)  1/308 (0.32%) 
Gastrointestinal disorders     
Abdominal pain † 1  2/622 (0.32%)  0/308 (0.00%) 
Abdominal incarcerated hernia † 1  1/622 (0.16%)  0/308 (0.00%) 
Gastric ulcer haemorrhage † 1  1/622 (0.16%)  0/308 (0.00%) 
Gastrointestinal haemorrhage † 1  1/622 (0.16%)  0/308 (0.00%) 
Haemorrhoidal haemorrhage † 1  1/622 (0.16%)  0/308 (0.00%) 
Small intestinal obstruction † 1  1/622 (0.16%)  0/308 (0.00%) 
Vomiting † 1  1/622 (0.16%)  0/308 (0.00%) 
Dysphagia † 1  0/622 (0.00%)  1/308 (0.32%) 
Inguinal hernia † 1  0/622 (0.00%)  2/308 (0.65%) 
Lower gastrointestinal haemorrhage † 1  0/622 (0.00%)  1/308 (0.32%) 
General disorders     
Chest discomfort † 1  1/622 (0.16%)  0/308 (0.00%) 
Chest pain † 1  1/622 (0.16%)  0/308 (0.00%) 
Gait disturbance † 1  1/622 (0.16%)  0/308 (0.00%) 
Multiple organ dysfunction syndrome † 1  0/622 (0.00%)  1/308 (0.32%) 
Hepatobiliary disorders     
Cholecystitis † 1  0/622 (0.00%)  1/308 (0.32%) 
Cholecystitis acute † 1  0/622 (0.00%)  1/308 (0.32%) 
Infections and infestations     
Urinary tract infection † 1  3/622 (0.48%)  2/308 (0.65%) 
Appendicitis perforated † 1  2/622 (0.32%)  0/308 (0.00%) 
Bronchitis † 1  2/622 (0.32%)  1/308 (0.32%) 
Cellulitis † 1  2/622 (0.32%)  0/308 (0.00%) 
Pneumonia † 1  2/622 (0.32%)  1/308 (0.32%) 
Endocarditis † 1  1/622 (0.16%)  0/308 (0.00%) 
Gastroenteritis † 1  1/622 (0.16%)  0/308 (0.00%) 
Pyelonephritis acute † 1  1/622 (0.16%)  0/308 (0.00%) 
Septic shock † 1  1/622 (0.16%)  0/308 (0.00%) 
Tooth abscess † 1  1/622 (0.16%)  0/308 (0.00%) 
Upper respiratory tract infection † 1  1/622 (0.16%)  0/308 (0.00%) 
Osteomyelitis † 1  0/622 (0.00%)  1/308 (0.32%) 
Urosepsis † 1  0/622 (0.00%)  1/308 (0.32%) 
Injury, poisoning and procedural complications     
Fall † 1  2/622 (0.32%)  0/308 (0.00%) 
Pulmonary contusion † 1  2/622 (0.32%)  0/308 (0.00%) 
Alcohol poisoning † 1  1/622 (0.16%)  0/308 (0.00%) 
Brachial plexus injury † 1  1/622 (0.16%)  0/308 (0.00%) 
Cystitis radiation † 1  1/622 (0.16%)  0/308 (0.00%) 
Femoral neck fracture † 1  1/622 (0.16%)  0/308 (0.00%) 
Hip fracture † 1  1/622 (0.16%)  0/308 (0.00%) 
Rib fracture † 1  1/622 (0.16%)  0/308 (0.00%) 
Road traffic accident † 1  1/622 (0.16%)  0/308 (0.00%) 
Shunt aneurysm † 1  1/622 (0.16%)  0/308 (0.00%) 
Spinal compression fracture † 1  1/622 (0.16%)  0/308 (0.00%) 
Traumatic fracture † 1  1/622 (0.16%)  0/308 (0.00%) 
Ankle fracture † 1  0/622 (0.00%)  1/308 (0.32%) 
Subcutaneous haematoma † 1  0/622 (0.00%)  1/308 (0.32%) 
Investigations     
Blood sodium decreased † 1  1/622 (0.16%)  0/308 (0.00%) 
Troponin increased † 1  1/622 (0.16%)  0/308 (0.00%) 
Liver function test abnormal † 1  0/622 (0.00%)  1/308 (0.32%) 
Metabolism and nutrition disorders     
Dehydration † 1  1/622 (0.16%)  0/308 (0.00%) 
Diabetes mellitus inadequate control † 1  1/622 (0.16%)  0/308 (0.00%) 
Hyponatraemia † 1  1/622 (0.16%)  0/308 (0.00%) 
Hyperglycaemia † 1  0/622 (0.00%)  1/308 (0.32%) 
Musculoskeletal and connective tissue disorders     
Pathological fracture † 1  2/622 (0.32%)  0/308 (0.00%) 
Arthropathy † 1  1/622 (0.16%)  0/308 (0.00%) 
Intervertebral disc compression † 1  1/622 (0.16%)  0/308 (0.00%) 
Osteoarthritis † 1  1/622 (0.16%)  0/308 (0.00%) 
Osteonecrosis † 1  1/622 (0.16%)  0/308 (0.00%) 
Pain in extremity † 1  1/622 (0.16%)  0/308 (0.00%) 
Rhabdomyolysis † 1  0/622 (0.00%)  1/308 (0.32%) 
Spinal pain † 1  0/622 (0.00%)  1/308 (0.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon † 1  2/622 (0.32%)  0/308 (0.00%) 
Metastases to bone † 1  2/622 (0.32%)  1/308 (0.32%) 
Prostate cancer † 1  2/622 (0.32%)  0/308 (0.00%) 
Prostate cancer metastatic † 1  2/622 (0.32%)  2/308 (0.65%) 
Basal cell carcinoma † 1  1/622 (0.16%)  0/308 (0.00%) 
Bladder transitional cell carcinoma stage II † 1  1/622 (0.16%)  0/308 (0.00%) 
Malignant melanoma in situ † 1  1/622 (0.16%)  0/308 (0.00%) 
Malignant melanoma stage I † 1  1/622 (0.16%)  0/308 (0.00%) 
Metastases to liver † 1  1/622 (0.16%)  0/308 (0.00%) 
Non-small cell lung cancer metastatic † 1  1/622 (0.16%)  0/308 (0.00%) 
Schwannoma † 1  1/622 (0.16%)  0/308 (0.00%) 
Small cell lung cancer metastatic † 1  1/622 (0.16%)  0/308 (0.00%) 
Transitional cell cancer of the renal pelvis and ureter † 1  1/622 (0.16%)  0/308 (0.00%) 
Cancer pain † 1  0/622 (0.00%)  1/308 (0.32%) 
Metastases to spine † 1  0/622 (0.00%)  1/308 (0.32%) 
Transitional cell carcinoma † 1  0/622 (0.00%)  1/308 (0.32%) 
Nervous system disorders     
Ischaemic stroke † 1  2/622 (0.32%)  0/308 (0.00%) 
Encephalopathy † 1  1/622 (0.16%)  0/308 (0.00%) 
Haemorrhagic stroke † 1  1/622 (0.16%)  0/308 (0.00%) 
Hemiparesis † 1  1/622 (0.16%)  0/308 (0.00%) 
Lacunar infarction † 1  1/622 (0.16%)  0/308 (0.00%) 
Spinal cord compression † 1  1/622 (0.16%)  0/308 (0.00%) 
Cerebral haemorrhage † 1  0/622 (0.00%)  2/308 (0.65%) 
Cerebrovascular accident † 1  0/622 (0.00%)  1/308 (0.32%) 
Dizziness † 1  0/622 (0.00%)  1/308 (0.32%) 
Haemorrhage intracranial † 1  0/622 (0.00%)  1/308 (0.32%) 
Presyncope † 1  0/622 (0.00%)  2/308 (0.65%) 
Syncope † 1  0/622 (0.00%)  2/308 (0.65%) 
Transient ischaemic attack † 1  0/622 (0.00%)  3/308 (0.97%) 
Psychiatric disorders     
Mental disorder † 1  1/622 (0.16%)  0/308 (0.00%) 
Suicidal ideation † 1  1/622 (0.16%)  0/308 (0.00%) 
Renal and urinary disorders     
Acute kidney injury † 1  4/622 (0.64%)  1/308 (0.32%) 
Bladder obstruction † 1  2/622 (0.32%)  0/308 (0.00%) 
Bladder neck obstruction † 1  1/622 (0.16%)  0/308 (0.00%) 
Bladder outlet obstruction † 1  1/622 (0.16%)  0/308 (0.00%) 
Calculus bladder † 1  1/622 (0.16%)  1/308 (0.32%) 
Chronic kidney disease † 1  1/622 (0.16%)  0/308 (0.00%) 
Lower urinary tract symptoms † 1  1/622 (0.16%)  0/308 (0.00%) 
Renal failure † 1  1/622 (0.16%)  0/308 (0.00%) 
Tubulointerstitial nephritis † 1  1/622 (0.16%)  0/308 (0.00%) 
Urethral stenosis † 1  1/622 (0.16%)  0/308 (0.00%) 
Urinary bladder polyp † 1  1/622 (0.16%)  0/308 (0.00%) 
Urinary retention † 1  1/622 (0.16%)  0/308 (0.00%) 
Haematuria † 1  0/622 (0.00%)  1/308 (0.32%) 
Hydronephrosis † 1  0/622 (0.00%)  1/308 (0.32%) 
Micturition urgency † 1  0/622 (0.00%)  1/308 (0.32%) 
Urinary tract obstruction † 1  0/622 (0.00%)  1/308 (0.32%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia † 1  2/622 (0.32%)  1/308 (0.32%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease † 1  2/622 (0.32%)  1/308 (0.32%) 
Pneumothorax † 1  1/622 (0.16%)  0/308 (0.00%) 
Acute respiratory failure † 1  0/622 (0.00%)  1/308 (0.32%) 
Epistaxis † 1  0/622 (0.00%)  1/308 (0.32%) 
Pneumonia aspiration † 1  0/622 (0.00%)  1/308 (0.32%) 
Pulmonary embolism † 1  0/622 (0.00%)  1/308 (0.32%) 
Pulmonary oedema † 1  0/622 (0.00%)  1/308 (0.32%) 
Social circumstances     
Homicide † 1  0/622 (0.00%)  1/308 (0.32%) 
Vascular disorders     
Aortic stenosis † 1  1/622 (0.16%)  1/308 (0.32%) 
Aortic aneurysm † 1  0/622 (0.00%)  1/308 (0.32%) 
Deep vein thrombosis † 1  0/622 (0.00%)  1/308 (0.32%) 
1
Term from vocabulary, 22.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Relugolix Leuprolide Acetate
Affected / at Risk (%) Affected / at Risk (%)
Total   493/622 (79.26%)   239/308 (77.60%) 
Gastrointestinal disorders     
Constipation † 1  76/622 (12.22%)  30/308 (9.74%) 
Diarrhoea † 1  76/622 (12.22%)  21/308 (6.82%) 
Nausea † 1  36/622 (5.79%)  13/308 (4.22%) 
General disorders     
Asthenia † 1  32/622 (5.14%)  21/308 (6.82%) 
Fatigue † 1  134/622 (21.54%)  57/308 (18.51%) 
Infections and infestations     
Nasopharyngitis † 1  59/622 (9.49%)  29/308 (9.42%) 
Investigations     
Weight increased † 1  49/622 (7.88%)  20/308 (6.49%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  75/622 (12.06%)  28/308 (9.09%) 
Back pain † 1  50/622 (8.04%)  28/308 (9.09%) 
Pain in extremity † 1  32/622 (5.14%)  19/308 (6.17%) 
Nervous system disorders     
Dizziness † 1  35/622 (5.63%)  17/308 (5.52%) 
Headache † 1  35/622 (5.63%)  13/308 (4.22%) 
Psychiatric disorders     
Insomnia † 1  43/622 (6.91%)  14/308 (4.55%) 
Renal and urinary disorders     
Nocturia † 1  36/622 (5.79%)  19/308 (6.17%) 
Pollakiuria † 1  37/622 (5.95%)  20/308 (6.49%) 
Urinary incontinence † 1  30/622 (4.82%)  16/308 (5.19%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis † 1  15/622 (2.41%)  16/308 (5.19%) 
Vascular disorders     
Hot flush † 1  338/622 (54.34%)  159/308 (51.62%) 
Hypertension † 1  49/622 (7.88%)  36/308 (11.69%) 
1
Term from vocabulary, 22.0
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials at Myovant
Organization: Myovant Sciences GmbH
Phone: 650-278-8743
EMail: ClinicalTrials@Myovant.com
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03085095    
Other Study ID Numbers: MVT-601-3201
2017-000160-15 ( EudraCT Number )
First Submitted: March 9, 2017
First Posted: March 21, 2017
Results First Submitted: January 19, 2021
Results First Posted: March 25, 2021
Last Update Posted: January 18, 2022