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A Study of Degarelix in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00928434
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Degarelix
Drug: Leuprolide
Enrollment 409
Recruitment Details  
Pre-assignment Details Of the total 409 patients enrolled, six patients were not dosed either due to randomisation error, failing eligibility criteria or consent withdrawal after being randomised.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous)
Hide Arm/Group Description

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

Period Title: Overall Study
Started 175 [1] 50 [1] 178 [1]
Full Phase B Analysis Set 137 [2] 41 [2] 150 [2]
Completed 131 36 134
Not Completed 44 14 44
Reason Not Completed
Adverse Event             14             5             18
Protocol Violation             5             0             8
Physician Decision             2             0             3
Lost to Follow-up             1             0             3
Withdrawal by Subject             5             3             2
PSA failure (>2 ng/mL) at Visit 8             10             4             7
PSA failure (>2 ng/mL) on other visit             2             1             1
Other (not meeting above criteria)             5             1             2
[1]
Full Analysis Set Patients
[2]
Patients completing 7 months treatment with PSA<2 ng/mL, and having one primary efficacy assessment.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total
Hide Arm/Group Description

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer's labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)

Total of all reporting groups
Overall Number of Baseline Participants 175 50 178 403
Hide Baseline Analysis Population Description
Analysis population consist of Full Analysis Set (FAS), which comprised of subjects who received at least one dose of IMP and had at least one efficacy assessment after dosing.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants 50 participants 178 participants 403 participants
71.9  (8.89) 71.7  (8.14) 71.0  (8.44) 71.5  (8.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 50 participants 178 participants 403 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
175
 100.0%
50
 100.0%
178
 100.0%
403
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 50 participants 178 participants 403 participants
Hispanic or Latino
17
   9.7%
4
   8.0%
14
   7.9%
35
   8.7%
Not Hispanic or Latino
158
  90.3%
46
  92.0%
164
  92.1%
368
  91.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 50 participants 178 participants 403 participants
American Indian or Alaska Native
2
   1.1%
1
   2.0%
2
   1.1%
5
   1.2%
Asian
0
   0.0%
1
   2.0%
1
   0.6%
2
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
32
  18.3%
9
  18.0%
38
  21.3%
79
  19.6%
White
140
  80.0%
39
  78.0%
137
  77.0%
316
  78.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.6%
0
   0.0%
0
   0.0%
1
   0.2%
Height  
Mean (Standard Deviation)
Unit of measure:  Meter
Number Analyzed 175 participants 50 participants 178 participants 403 participants
1.77  (0.089) 1.74  (0.089) 1.76  (0.080) 1.76  (0.085)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 175 participants 50 participants 178 participants 403 participants
90.3  (19.4) 88.4  (15.8) 91.9  (16.9) 90.8  (17.9)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 175 participants 50 participants 178 participants 403 participants
28.9  (5.45) 29.2  (4.89) 29.6  (4.94) 29.2  (5.16)
Prostate Specific Antigen (PSA)  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 175 participants 50 participants 178 participants 403 participants
16.4  (66.3) 15.6  (32.2) 10.7  (24.4) 13.8  (48)
Testosterone  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 175 participants 50 participants 178 participants 403 participants
3.65  (1.43) 3.90  (1.59) 3.76  (1.58) 3.73  (1.52)
1.Primary Outcome
Title Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL
Hide Description Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.
Time Frame At 14 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
100
(97.3 to 100)
98.4
(95.5 to 99.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DI (Degarelix Intermittent), Total Continuous
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was defined as a lower bound (LCL) of the 95% confidence interval for the difference between the intermittent and pooled continuous treatments, CADT, (intermittent - continuous) of greater than -12.5%.
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 1.57
Confidence Interval (2-Sided) 95%
-0.19 to 3.33
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Absolute Change From Baseline in Serum PSA Levels
Hide Description Absolute change from Baseline in serum PSA levels during the study period was measured.
Time Frame Phase A Visit 1-8 and Phase B Visit 9-15.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous)
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

Overall Number of Participants Analyzed 137 41 150
Mean (Standard Deviation)
Unit of Measure: ng/mL
Phase A, Visit 1 (Day 0) NA [1]   (NA) -0.91 [2]   (NA) NA [1]   (NA)
Phase A, Visit 2 (Month 1) -6.39  (10.2) -14.3  (34.8) -6.38  (13.2)
Phase A, Visit 3 (Month 2) -6.94  (10.8) -14.8  (34.9) -8.12  (15.4)
Phase A, Visit 4 (Month 3) -7.07  (10.9) -15  (35) -8.44  (15.7)
Phase A, Visit 5 (Month 4) -7.16  (11) -15.1  (35.2) -8.51  (15.8)
Phase A, Visit 6 (Month 5) -7.19  (11) -15.1  (35.2) -8.59  (15.9)
Phase A, Visit 7 (Month 6) -7.21  (10.9) -15.1  (35.2) -8.64  (15.9)
Phase A, Visit 8 (Month 7) -7.24  (11) -15.1  (35.2) -8.64  (15.9)
Phase B, Visit 9 (Month 8) -7.25  (11) -15  (34.7) -8.64  (15.9)
Phase B, Visit 10 (Month 9) -7.18  (11) -15  (34.7) -8.64  (15.9)
Phase B, Visit 11 (Month 10) -7.07  (10.9) -14.9  (34.3) -8.63  (15.9)
Phase B, Visit 12 (Month 11) -6.96  (10.9) -14.9  (33.9) -8.64  (15.9)
Phase B, Visit 13 (Month 12) -6.81  (11) -14.8  (33.9) -8.64  (15.9)
Phase B, Visit 14 (Month 13) -6.79  (11) -14.8  (33.9) -8.59  (16)
Phase B, Visit 15 (Month 14) -6.74  (11) -14.8  (33.9) -8.6  (15.9)
[1]
This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.
[2]
One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.
3.Secondary Outcome
Title Percent Change From Baseline in Serum PSA Levels
Hide Description Percent change from Baseline in serum PSA levels during the study period was measured.
Time Frame Phase A Visit 1-8 and Phase B Visit 9-15.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous)
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

Overall Number of Participants Analyzed 137 41 150
Mean (Standard Deviation)
Unit of Measure: Percent change
Phase A, Visit 1 (Day 0) NA [1]   (NA) -39.6 [2]   (NA) NA [1]   (NA)
Phase A, Visit 2 (Month 1) -80.8  (24.4) -84.5  (11.8) -62.8  (31.2)
Phase A, Visit 3 (Month 2) -90.4  (12.2) -92.4  (8.23) -87.3  (12.3)
Phase A, Visit 4 (Month 3) -92.8  (9.9) -94.5  (7.37) -92.3  (7.67)
Phase A, Visit 5 (Month 4) -94.1  (8.45) -95.5  (7.05) -93.4  (9.39)
Phase A, Visit 6 (Month 5) -94.2  (9.31) -95.7  (7.8) -94.5  (7.52)
Phase A, Visit 7 (Month 6) -94.8  (8.34) -95.8  (8.64) -95.3  (7.23)
Phase A, Visit 8 (Month 7) -95.4  (7.13) -95.4  (10.8) -95.5  (7.62)
Phase B, Visit 9 (Month 8) -95.7  (6.97) -95.5  (10.3) -95.2  (12.3)
Phase B, Visit 10 (Month 9) -93.6  (11.5) -95.6  (10.6) -94.3  (23.2)
Phase B, Visit 11 (Month 10) -91.9  (13.4) -95.7  (9.46) -93.1  (24.9)
Phase B, Visit 12 (Month 11) -88  (22.7) -95.1  (11.9) -94.4  (23.5)
Phase B, Visit 13 (Month 12) -84.2  (24.9) -95.1  (10.6) -94.5  (23.5)
Phase B, Visit 14 (Month 13) -82.8  (24.9) -95.1  (10.4) -93.1  (25.9)
Phase B, Visit 15 (Month 14) -80.8  (26.4) -94.4  (12.9) -93.7  (25.8)
[1]
This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.
[2]
One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.
4.Secondary Outcome
Title Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being
Hide Description

The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.

Physical well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the physical well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.

Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
-1.47
(-1.99 to -0.94)
-1.63
(-2.59 to -0.67)
-1.41
(-1.92 to -0.90)
-1.46
(-1.90 to -1.01)
Phase A, Month 7
-1.41
(-1.93 to -0.88)
-1.48
(-2.43 to -0.52)
-1.67
(-2.17 to -1.17)
-1.63
(-2.07 to -1.18)
Phase B, Month 8
-0.96
(-1.46 to -0.46)
-1.92
(-2.83 to -1.01)
-1.74
(-2.22 to -1.27)
-1.78
(-2.20 to -1.36)
Phase B, Month 9
-1.24
(-1.80 to -0.68)
-1.85
(-2.87 to -0.82)
-1.77
(-2.31 to -1.24)
-1.79
(-2.26 to -1.32)
Phase B, Month 10
-1.05
(-1.63 to -0.48)
-2.08
(-3.13 to -1.03)
-1.68
(-2.23 to -1.13)
-1.76
(-2.25 to -1.28)
Phase B, Month 11
-1.00
(-1.56 to -0.44)
-1.77
(-2.79 to -0.75)
-1.53
(-2.07 to -1.00)
-1.58
(-2.05 to -1.11)
Phase B, Month 12
-0.91
(-1.44 to -0.38)
-1.62
(-2.59 to -0.66)
-1.32
(-1.83 to -0.82)
-1.39
(-1.83 to -0.94)
Phase B, Month 13
-1.00
(-1.57 to -0.43)
-2.10
(-3.14 to -1.06)
-1.40
(-1.95 to -0.86)
-1.55
(-2.04 to -1.07)
Phase B, Month 14
-1.04
(-1.62 to -0.47)
-1.90
(-2.95 to -0.85)
-1.45
(-2.00 to -0.91)
-1.55
(-2.03 to -1.06)
5.Secondary Outcome
Title Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being
Hide Description

The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.

Emotional well-being consist of 6 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the emotional well-being sub scale ranges from 0 to 24. Higher scores represent better QoL.Higher scores represent better QoL.

Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
0.69
(0.18 to 1.20)
1.31
(0.37 to 2.24)
0.76
(0.27 to 1.24)
0.88
(0.45 to 1.30)
Phase A, Month 7
0.67
(0.16 to 1.18)
0.57
(-0.37 to 1.51)
0.90
(0.42 to 1.39)
0.83
(0.40 to 1.26)
Phase B, Month 8
0.65
(0.16 to 1.14)
0.95
(0.05 to 1.86)
1.11
(0.65 to 1.58)
1.08
(0.67 to 1.49)
Phase B, Month 9
0.75
(0.27 to 1.24)
1.11
(0.22 to 2.01)
1.16
(0.70 to 1.62)
1.15
(0.74 to 1.56)
Phase B, Month 10
1.09
(0.57 to 1.60)
0.00
(-0.94 to 0.95)
0.98
(0.49 to 1.46)
0.77
(0.34 to 1.20)
Phase B, Month 11
0.82
(0.34 to 1.30)
0.94
(0.06 to 1.83)
1.05
(0.59 to 1.50)
1.03
(0.62 to 1.43)
Phase B, Month 12
0.99
(0.47 to 1.50)
1.07
(0.12 to 2.02)
1.23
(0.74 to 1.72)
1.20
(0.76 to 1.63)
Phase B, Month 13
0.74
(0.22 to 1.26)
0.52
(-0.43 to 1.48)
1.14
(0.64 to 1.63)
1.01
(0.57 to 1.45)
Phase B, Month 14
0.40
(-0.13 to 0.93)
0.86
(-0.11 to 1.83)
1.12
(0.62 to 1.62)
1.06
(0.62 to 1.51)
6.Secondary Outcome
Title Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being
Hide Description

The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.

Social well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the social well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.

Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
-0.18
(-0.96 to 0.60)
-0.06
(-1.48 to 1.35)
-0.36
(-1.11 to 0.38)
-0.30
(-0.95 to 0.36)
Phase A, Month 7
0.00
(-0.79 to 0.79)
-0.30
(-1.75 to 1.14)
-0.46
(-1.21 to 0.29)
-0.43
(-1.09 to 0.24)
Phase B, Month 8
-0.33
(-1.06 to 0.39)
-0.52
(-1.84 to 0.80)
-0.41
(-1.10 to 0.28)
-0.43
(-1.04 to 0.18)
Phase B, Month 9
-0.02
(-0.80 to 0.77)
-0.95
(-2.37 to 0.47)
-1.10
(-1.84 to -0.36)
-1.07
(-1.72 to -0.41)
Phase B, Month 10
0.36
(-0.42 to 1.14)
-1.00
(-2.42 to 0.42)
-1.15
(-1.89 to -0.41)
-1.12
(-1.77 to -0.46)
Phase B, Month 11
0.20
(-0.63 to 1.02)
-1.09
(-2.59 to 0.42)
-0.83
(-1.61 to -0.05)
-0.88
(-1.58 to -0.19)
Phase B, Month 12
-0.16
(-0.94 to 0.63)
-1.34
(-2.78 to 0.09)
-0.85
(-1.59 to -0.10)
-0.95
(-1.61 to -0.29)
Phase B, Month 13
-0.02
(-0.79 to 0.74)
-1.35
(-2.74 to 0.03)
-0.72
(-1.44 to 0.00)
-0.85
(-1.49 to -0.21)
Phase B, Month 14
0.28
(-0.44 to 1.01)
-0.68
(-2.00 to 0.64)
-0.55
(-1.24 to 0.14)
-0.58
(-1.19 to 0.03)
7.Secondary Outcome
Title Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being
Hide Description

The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.

Functional well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the functional well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.

Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
-0.96
(-1.70 to -0.23)
-0.88
(-2.23 to 0.47)
-0.29
(-0.99 to 0.41)
-0.42
(-1.04 to 0.21)
Phase A, Month 7
-1.41
(-2.25 to -0.58)
-0.78
(-2.31 to 0.76)
-1.24
(-2.03 to -0.45)
-1.15
(-1.85 to -0.44)
Phase B, Month 8
-1.18
(-1.90 to -0.45)
-1.08
(-2.41 to 0.26)
-0.73
(-1.42 to -0.04)
-0.80
(-1.41 to -0.19)
Phase B, Month 9
-1.14
(-1.94 to -0.34)
-1.07
(-2.53 to 0.40)
-1.23
(-1.99 to -0.47)
-1.20
(-1.87 to -0.52)
Phase B, Month 10
-1.35
(-2.15 to -0.54)
-0.89
(-2.36 to 0.58)
-1.42
(-2.18 to -0.66)
-1.31
(-1.98 to -0.63)
Phase B, Month 11
-1.25
(-2.08 to -0.43)
-0.80
(-2.32 to 0.72)
-1.24
(-2.02 to -0.46)
-1.15
(-1.84 to -0.45)
Phase B, Month 12
-0.92
(-1.70 to -0.15)
-1.49
(-2.91 to -0.07)
-0.73
(-1.46 to 0.00)
-0.89
(-1.54 to -0.24)
Phase B, Month 13
-1.49
(-2.32 to -0.66)
-2.22
(-3.75 to -0.69)
-0.96
(-1.75 to -0.17)
-1.22
(-1.93 to -0.52)
Phase B, Month 14
-1.02
(-1.78 to -0.26)
-1.95
(-3.35 to -0.55)
-0.84
(-1.56 to -0.12)
-1.07
(-1.71 to -0.43)
8.Secondary Outcome
Title Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns
Hide Description

The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.

Additional concerns consist of 12 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the additional concerns ranges from 0 to 48. Higher scores represent better QoL.

Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
-1.14
(-1.96 to -0.32)
-0.92
(-2.42 to 0.57)
-0.51
(-1.30 to 0.27)
-0.60
(-1.29 to 0.09)
Phase A, Month 7
-0.89
(-1.71 to -0.07)
-1.34
(-2.83 to 0.16)
-1.03
(-1.81 to -0.25)
-1.10
(-1.79 to -0.40)
Phase B, Month 8
-1.29
(-2.10 to -0.48)
-1.03
(-2.50 to 0.45)
-0.63
(-1.40 to 0.14)
-0.72
(-1.40 to -0.03)
Phase B, Month 9
-0.97
(-1.83 to -0.11)
-1.64
(-3.20 to -0.07)
-0.90
(-1.72 to -0.08)
-1.06
(-1.79 to -0.34)
Phase B, Month 10
-0.86
(-1.73 to 0.01)
-0.80
(-2.39 to 0.78)
-0.70
(-1.52 to 0.13)
-0.72
(-1.45 to 0.01)
Phase B, Month 11
-0.80
(-1.62 to 0.01)
-0.56
(-2.05 to 0.92)
-0.58
(-1.35 to 0.20)
-0.57
(-1.26 to 0.11)
Phase B, Month 12
-0.75
(-1.60 to 0.10)
-1.20
(-2.75 to 0.35)
-0.75
(-1.56 to 0.06)
-0.84
(-1.56 to -0.13)
Phase B, Month 13
-0.91
(-1.75 to -0.08)
-0.96
(-2.47 to 0.56)
-0.86
(-1.65 to -0.06)
-0.88
(-1.58 to -0.18)
Phase B, Month 14
-0.81
(-1.69 to 0.06)
-0.67
(-2.26 to 0.92)
-0.27
(-1.10 to 0.57)
-0.35
(-1.09 to 0.38)
9.Secondary Outcome
Title Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score
Hide Description The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Total FACT-P scores ranges from 0 to 156. Higher scores represent better QoL.
Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
-1.86
(-3.62 to -0.10)
-1.89
(-5.13 to 1.34)
-1.23
(-2.92 to 0.45)
-1.37
(-2.87 to 0.12)
Phase A, Month 7
-2.03
(-3.87 to -0.19)
-2.64
(-6.03 to 0.76)
-2.38
(-4.12 to -0.63)
-2.43
(-3.98 to -0.88)
Phase B, Month 8
-1.75
(-3.45 to -0.04)
-3.12
(-6.26 to 0.03)
-1.69
(-3.31 to -0.07)
-1.99
(-3.42 to -0.55)
Phase B, Month 9
-1.61
(-3.46 to 0.23)
-3.49
(-6.89 to -0.10)
-2.84
(-4.59 to -1.09)
-2.98
(-4.53 to -1.42)
Phase B, Month 10
-0.89
(-2.84 to 1.05)
-4.56
(-8.15 to -0.98)
-3.16
(-5.01 to -1.31)
-3.45
(-5.09 to -1.81)
Phase B, Month 11
-1.18
(-3.10 to 0.73)
-3.27
(-6.79 to 0.26)
-2.48
(-4.30 to -0.67)
-2.65
(-4.26 to -1.04)
Phase B, Month 12
-0.95
(-2.88 to 0.98)
-3.97
(-7.52 to -0.42)
-1.60
(-3.43 to 0.23)
-2.09
(-3.72 to -0.47)
Phase B, Month 13
-1.74
(-3.72 to 0.24)
-5.62
(-9.26 to -1.97)
-1.85
(-3.73 to 0.02)
-2.64
(-4.32 to -0.97)
Phase B, Month 14
-1.36
(-3.24 to 0.52)
-4.28
(-7.75 to -0.81)
-1.65
(-3.44 to 0.13)
-2.20
(-3.79 to -0.61)
10.Secondary Outcome
Title Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive
Hide Description

The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.

Sexual drive domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the sexual drive domain ranges from 0 to 8. A higher scores represent better sexual function.

Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
-1.57
(-1.83 to -1.32)
-1.57
(-2.04 to -1.10)
-1.27
(-1.51 to -1.03)
-1.33
(-1.55 to -1.12)
Phase A, Month 7
-1.71
(-1.96 to -1.47)
-1.39
(-1.84 to -0.94)
-1.67
(-1.90 to -1.44)
-1.61
(-1.82 to -1.41)
Phase B, Month 9
-1.72
(-1.98 to -1.46)
-1.51
(-1.99 to -1.02)
-1.62
(-1.87 to -1.37)
-1.60
(-1.82 to -1.38)
Phase B, Month 11
-1.59
(-1.85 to -1.34)
-1.52
(-1.99 to -1.05)
-1.65
(-1.89 to -1.42)
-1.63
(-1.84 to -1.41)
Phase B, Month 13
-1.44
(-1.69 to -1.19)
-1.55
(-2.02 to -1.08)
-1.72
(-1.96 to -1.48)
-1.69
(-1.90 to -1.47)
Phase B, Month 14
-1.30
(-1.55 to -1.04)
-1.65
(-2.12 to -1.17)
-1.72
(-1.96 to -1.48)
-1.71
(-1.92 to -1.49)
11.Secondary Outcome
Title Change From Baseline in Sexual Function as Assessed by the SFI: Erection
Hide Description

The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.

Erection domain consist of 3 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the erection domain ranges from 0 to 12. A higher scores represent better sexual function.

Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
-1.32
(-1.62 to -1.01)
-0.91
(-1.48 to -0.35)
-1.21
(-1.50 to -0.91)
-1.14
(-1.40 to -0.89)
Phase A, Month 7
-1.43
(-1.75 to -1.11)
-1.06
(-1.65 to -0.47)
-1.34
(-1.65 to -1.03)
-1.28
(-1.55 to -1.01)
Phase B, Month 9
-1.52
(-1.80 to -1.23)
-1.07
(-1.60 to -0.54)
-1.46
(-1.74 to -1.19)
-1.38
(-1.62 to -1.14)
Phase B, Month 11
-1.15
(-1.44 to -0.86)
-1.34
(-1.88 to -0.80)
-1.28
(-1.56 to -1.01)
-1.30
(-1.54 to -1.05)
Phase B, Month 13
-0.97
(-1.30 to -0.64)
-1.36
(-1.97 to -0.74)
-1.33
(-1.65 to -1.02)
-1.34
(-1.62 to -1.06)
Phase B, Month 14
-0.90
(-1.25 to -0.56)
-1.43
(-2.08 to -0.79)
-1.26
(-1.59 to -0.93)
-1.29
(-1.59 to -1.00)
12.Secondary Outcome
Title Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation
Hide Description

The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.

Ejaculation domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the ejaculation domain ranges from 0 to 8. A higher scores represent better sexual function.

Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
-1.04
(-1.33 to -0.75)
-0.90
(-1.43 to -0.37)
-0.87
(-1.15 to -0.59)
-0.88
(-1.13 to -0.63)
Phase A, Month 7
-1.23
(-1.48 to -0.97)
-0.80
(-1.27 to -0.34)
-1.08
(-1.32 to -0.84)
-1.02
(-1.23 to -0.80)
Phase B, Month 9
-1.24
(-1.51 to -0.98)
-1.06
(-1.55 to -0.57)
-0.94
(-1.20 to -0.69)
-0.97
(-1.20 to -0.74)
Phase B, Month 11
-0.94
(-1.22 to -0.67)
-1.24
(-1.74 to -0.74)
-0.93
(-1.19 to -0.67)
-1.00
(-1.23 to -0.76)
Phase B, Month 13
-0.89
(-1.15 to -0.62)
-1.07
(-1.56 to -0.58)
-1.12
(-1.38 to -0.87)
-1.11
(-1.34 to -0.89)
Phase B, Month 14
-0.79
(-1.10 to -0.48)
-1.17
(-1.73 to -0.61)
-0.97
(-1.27 to -0.68)
-1.01
(-1.27 to -0.75)
13.Secondary Outcome
Title Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment
Hide Description

The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.

Problem assessment domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the problem assessment domain ranges from 0 to 8. A higher scores represent better sexual function.

Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
-0.26
(-0.93 to 0.41)
-0.58
(-1.82 to 0.66)
-0.36
(-1.00 to 0.28)
-0.40
(-0.97 to 0.16)
Phase A, Month 7
-0.90
(-1.60 to -0.19)
-0.88
(-2.19 to 0.44)
-0.57
(-1.25 to 0.11)
-0.63
(-1.23 to -0.03)
Phase B, Month 9
-0.56
(-1.30 to 0.17)
-0.71
(-2.07 to 0.65)
-0.64
(-1.34 to 0.06)
-0.66
(-1.28 to -0.03)
Phase B, Month 11
0.09
(-0.65 to 0.83)
-0.53
(-1.90 to 0.84)
-0.98
(-1.68 to -0.27)
-0.89
(-1.51 to -0.26)
Phase B, Month 13
-0.15
(-0.88 to 0.58)
-1.63
(-2.99 to -0.27)
-1.07
(-1.77 to -0.38)
-1.19
(-1.81 to -0.57)
Phase B, Month 14
-0.31
(-1.04 to 0.41)
-1.68
(-3.03 to -0.33)
-0.89
(-1.58 to -0.19)
-1.05
(-1.67 to -0.44)
14.Secondary Outcome
Title Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life
Hide Description

The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.

Overall satisfaction domain consist of single question and is scored on a scale of 0-4 (0=minimum, 4=maximum). A higher score represent better sexual function.

Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
-0.32
(-0.50 to -0.13)
-0.18
(-0.53 to 0.16)
-0.27
(-0.45 to -0.09)
-0.25
(-0.41 to -0.10)
Phase A, Month 7
-0.28
(-0.48 to -0.07)
-0.37
(-0.74 to 0.01)
-0.40
(-0.59 to -0.21)
-0.39
(-0.56 to -0.22)
Phase B, Month 9
-0.33
(-0.53 to -0.13)
-0.34
(-0.71 to 0.03)
-0.41
(-0.60 to -0.22)
-0.39
(-0.56 to -0.23)
Phase B, Month 11
-0.15
(-0.35 to 0.05)
-0.47
(-0.85 to -0.09)
-0.41
(-0.60 to -0.21)
-0.42
(-0.59 to -0.25)
Phase B, Month 13
-0.11
(-0.32 to 0.09)
-0.57
(-0.95 to -0.20)
-0.42
(-0.61 to -0.23)
-0.45
(-0.62 to -0.28)
Phase B, Month 14
-0.12
(-0.32 to 0.08)
-0.70
(-1.08 to -0.33)
-0.37
(-0.57 to -0.18)
-0.44
(-0.61 to -0.27)
15.Secondary Outcome
Title Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score
Hide Description The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Total SFI score ranges from 0 to 44. A higher scores represent better sexual function.
Time Frame During 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous) Total Continuous
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Overall Number of Participants Analyzed 137 41 150 191
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Phase A, Month 3
-4.07
(-5.10 to -3.05)
-3.93
(-5.84 to -2.02)
-3.69
(-4.67 to -2.71)
-3.74
(-4.61 to -2.87)
Phase A, Month 7
-5.20
(-6.23 to -4.16)
-4.28
(-6.21 to -2.35)
-4.57
(-5.56 to -3.58)
-4.51
(-5.38 to -3.63)
Phase B, Month 9
-4.97
(-6.04 to -3.91)
-4.35
(-6.33 to -2.37)
-4.62
(-5.63 to -3.61)
-4.56
(-5.46 to -3.66)
Phase B, Month 11
-3.56
(-4.63 to -2.49)
-4.62
(-6.62 to -2.63)
-4.74
(-5.76 to -3.72)
-4.71
(-5.62 to -3.81)
Phase B, Month 13
-3.37
(-4.48 to -2.26)
-5.59
(-7.66 to -3.52)
-5.15
(-6.21 to -4.09)
-5.24
(-6.18 to -4.30)
Phase B, Month 14
-3.27
(-4.41 to -2.12)
-5.93
(-8.06 to -3.80)
-4.68
(-5.77 to -3.59)
-4.94
(-5.91 to -3.97)
16.Secondary Outcome
Title Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL
Hide Description Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period.
Time Frame At 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous)
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

Overall Number of Participants Analyzed 137 41 150
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
100
(97.3 to 100)
97.6
(87.1 to 99.9)
98.7
(95.3 to 99.8)
17.Secondary Outcome
Title Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group
Hide Description The time to testosterone >0.5 ng/mL level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix)
Time Frame During Phase B
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent)
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Overall Number of Participants Analyzed 137
Median (95% Confidence Interval)
Unit of Measure: Days
112.0
(112.0 to 140.0)
18.Secondary Outcome
Title Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level
Hide Description The time to return to normal range (≥1.5 ng/mL) or Baseline testosterone level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix).
Time Frame During Phase B
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent)
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Overall Number of Participants Analyzed 137
Median (95% Confidence Interval)
Unit of Measure: Days
168
(140.0 to 168.0)
19.Secondary Outcome
Title Absolute Change From Baseline in Serum Testosterone Levels
Hide Description Absolute Change From Baseline in Serum Testosterone Levels was measured.
Time Frame Phase A Visit 1-8 and Phase B Visit 9-15.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous)
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

Overall Number of Participants Analyzed 137 41 150
Mean (Standard Deviation)
Unit of Measure: ng/mL
Phase A, Visit 1 (Day 0) NA [1]   (NA) -2.97 [2]   (NA) NA [1]   (NA)
Phase A, Visit 2 (Month 1) -3.64  (1.4) -3.77  (1.43) -3.7  (1.56)
Phase A, Visit 3 (Month 2) -3.67  (1.4) -3.77  (1.44) -3.77  (1.56)
Phase A, Visit 4 (Month 3) -3.68  (1.4) -3.78  (1.43) -3.77  (1.55)
Phase A, Visit 5 (Month 4) -3.67  (1.41) -3.78  (1.44) -3.74  (1.61)
Phase A, Visit 6 (Month 5) -3.67  (1.41) -3.78  (1.44) -3.78  (1.55)
Phase A, Visit 7 (Month 6) -3.66  (1.41) -3.77  (1.44) -3.77  (1.56)
Phase A, Visit 8 (Month 7) -3.66  (1.42) -3.78  (1.43) -3.78  (1.55)
Phase B, Visit 9 (Month 8) -3.63  (1.44) -3.76  (1.44) -3.78  (1.56)
Phase B, Visit 10 (Month 9) -3.41  (1.6) -3.76  (1.44) -3.78  (1.56)
Phase B, Visit 11 (Month 10) -3.0  (1.76) -3.75  (1.44) -3.77  (1.57)
Phase B, Visit 12 (Month 11) -2.57  (1.78) -3.74  (1.43) -3.78  (1.55)
Phase B, Visit 13 (Month 12) -2.18  (1.8) -3.72  (1.43) -3.78  (1.56)
Phase B, Visit 14 (Month 13) -2.1  (1.81) -3.73  (1.42) -3.77  (1.57)
Phase B, Visit 15 (Month 14) -1.77  (2.27) -3.71  (1.42) -3.78  (1.56)
[1]
This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.
[2]
One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.
20.Secondary Outcome
Title Percent Change From Baseline in Serum Testosterone Levels
Hide Description Percent change from Baseline in serum testosterone levels was measured.
Time Frame Phase A Visit 1-8 and Phase B Visit 9-15.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous)
Hide Arm/Group Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

Overall Number of Participants Analyzed 137 41 150
Mean (Standard Deviation)
Unit of Measure: Percent change
Phase A, Visit 1 (Day 0) NA [1]   (NA) -95.8 [2]   (NA) NA [1]   (NA)
Phase A, Visit 2 (Month 1) -96.4  (5.26) -97.4  (2.31) -95.5  (4.22)
Phase A, Visit 3 (Month 2) -97.3  (2.46) -97.5  (1.9) -97.7  (1.44)
Phase A, Visit 4 (Month 3) -97.5  (2.06) -97.8  (1.41) -97.5  (1.76)
Phase A, Visit 5 (Month 4) -97.2  (4.26) -97.7  (1.58) -96.2  (14)
Phase A, Visit 6 (Month 5) -97.3  (4.42) -97.6  (2.49) -97.8  (1.36)
Phase A, Visit 7 (Month 6) -96.8  (7.01) -97.6  (2.03) -97.9  (1.46)
Phase A, Visit 8 (Month 7) -96.9  (6.34) -97.5  (2.54) -97.7  (1.67)
Phase B, Visit 9 (Month 8) -95.6  (9.69) -97.1  (3.09) -97.8  (1.43)
Phase B, Visit 10 (Month 9) -88.7  (24.7) -97  (3.14) -97.7  (1.7)
Phase B, Visit 11 (Month 10) -77  (34.8) -97  (3.74) -97.5  (3.49)
Phase B, Visit 12 (Month 11) -65.4  (37.7) -96.7  (3.43) -97.9  (1.36)
Phase B, Visit 13 (Month 12) -54.7  (41.5) -96  (5.56) -97.8  (1.45)
Phase B, Visit 14 (Month 13) -51.9  (43.1) -96.5  (3.7) -97.4  (4.64)
Phase B, Visit 15 (Month 14) -44  (66.1) -95.8  (4.8) -97.7  (1.56)
[1]
This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.
[2]
One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.
Time Frame 15 months
Adverse Event Reporting Description Information related to AEs were collected throughout the trial from the time the subject signed the informed consent form till the end of the follow-up period.
 
Arm/Group Title DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous)
Hide Arm/Group Description

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.

During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.

Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).

All-Cause Mortality
DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/175 (14.86%)      6/50 (12.00%)      18/178 (10.11%)    
Blood and lymphatic system disorders       
Pancytopenia  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Cardiac disorders       
Coronary artery disease  1  1/175 (0.57%)  0/50 (0.00%)  3/178 (1.69%) 
Myocardial infarction  1  2/175 (1.14%)  0/50 (0.00%)  1/178 (0.56%) 
Acute myocardial infarction  1  2/175 (1.14%)  0/50 (0.00%)  0/178 (0.00%) 
Aortic valve stenosis  1  1/175 (0.57%)  0/50 (0.00%)  1/178 (0.56%) 
Cardiac failure congestive  1  0/175 (0.00%)  1/50 (2.00%)  1/178 (0.56%) 
Myocardial ischemia  1  1/175 (0.57%)  0/50 (0.00%)  1/178 (0.56%) 
Angina Pectoris  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Cardiac arrest  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Cardiac failure chronic  1  0/175 (0.00%)  1/50 (2.00%)  0/178 (0.00%) 
Cardio-respiratory arrest  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Coronary artery occlusion  1  0/175 (0.00%)  1/50 (2.00%)  0/178 (0.00%) 
Ear and labyrinth disorders       
Vertigo positional  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Gastrointestinal disorders       
Gastritis  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Peptic ulcer hemorrhage  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Small intestinal obstruction  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
General disorders       
Non-cardiac chest pain  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Hepatobiliary disorders       
Cholecystitis acute  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Immune system disorders       
Drug hypersensitivity  1  1/175 (0.57%)  0/50 (0.00%)  1/178 (0.56%) 
Infections and infestations       
Sepsis  1  1/175 (0.57%)  0/50 (0.00%)  1/178 (0.56%) 
Abdominal abscess  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Abscess limb  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Neutropenic infection  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Pneumonia  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Staphylococcal infection  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Subcutaneous abscess  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Injury, poisoning and procedural complications       
Hip fracture  1  0/0  0/50 (0.00%)  1/178 (0.56%) 
Injury  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Wound dehiscence  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus inadequate control  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Gout  1  0/175 (0.00%)  1/50 (2.00%)  0/178 (0.00%) 
Hyponatremia  1  0/175 (0.00%)  1/50 (2.00%)  0/178 (0.00%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis  1  2/175 (1.14%)  1/50 (2.00%)  0/178 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acute myeloid leukaemia  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Bile duct cancer  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Bladder cancer  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Lung adenocarcinoma  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Lung squamous cell carcinoma stage unspecified  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Neuroendocrine carcinoma of the skin  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Non-small cell lung cancer  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Pancreatic carcinoma metastatic  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Nervous system disorders       
Cerebrovascular accident  1  0/175 (0.00%)  0/50 (0.00%)  2/178 (1.12%) 
Presyncope  1  2/175 (1.14%)  0/50 (0.00%)  0/178 (0.00%) 
Carotid artery stenosis  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Dementia  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Dementia alzheimer's type  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Transient ischemic attack  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Syncope  1  0/175 (0.00%)  1/50 (2.00%)  2/178 (1.12%) 
Psychiatric disorders       
Psychotic disorder  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Renal and urinary disorders       
Renal failure acute  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Urethral stenosis  1  1/175 (0.57%)  0/50 (0.00%)  1/178 (0.56%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Epistaxis  1  0/175 (0.00%)  1/50 (2.00%)  0/178 (0.00%) 
Pleural effusion  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Pneumothorax  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Pulmonary edema  1  0/175 (0.00%)  1/50 (2.00%)  0/178 (0.00%) 
Respiratory failure  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  1/175 (0.57%)  1/50 (2.00%)  1/178 (0.56%) 
Aortic stenosis  1  2/175 (1.14%)  0/50 (0.00%)  0/178 (0.00%) 
Aortic aneurysm  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Pelvic venous thrombosis  1  1/175 (0.57%)  0/50 (0.00%)  0/178 (0.00%) 
Peripheral ischemia  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Subclavian steal syndrome  1  0/175 (0.00%)  0/50 (0.00%)  1/178 (0.56%) 
Venous insufficiency  1  0/175 (0.00%)  1/50 (2.00%)  0/178 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DI (Degarelix Intermittent) DC (Degarelix Continuous) LC (Leuprolide Continuous)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   159/175 (90.86%)      47/50 (94.00%)      158/178 (88.76%)    
Gastrointestinal disorders       
Constipation  1  8/175 (4.57%)  10 4/50 (8.00%)  4 12/178 (6.74%)  12
Nausea  1  10/175 (5.71%)  10 4/50 (8.00%)  4 5/178 (2.81%)  6
Diarrhoea  1  9/175 (5.14%)  10 3/50 (6.00%)  3 6/178 (3.37%)  6
Dyspepsia  1  1/175 (0.57%)  1 3/50 (6.00%)  3 0/178 (0.00%)  0
General disorders       
Injection site pain  1  79/175 (45.14%)  284 29/50 (58.00%)  150 19/178 (10.67%)  32
Fatigue  1  30/175 (17.14%)  41 10/50 (20.00%)  10 32/178 (17.98%)  32
Injection site erythema  1  42/175 (24.00%)  124 17/50 (34.00%)  56 1/178 (0.56%)  1
Injection site swelling  1  23/175 (13.14%)  40 5/50 (10.00%)  11 0/178 (0.00%)  0
Injection site oedema  1  6/175 (3.43%)  15 4/50 (8.00%)  21 0/178 (0.00%)  0
Pyrexia  1  5/175 (2.86%)  8 3/50 (6.00%)  3 2/178 (1.12%)  2
Injection site induration  1  1/175 (0.57%)  2 3/50 (6.00%)  16 0/178 (0.00%)  0
Infections and infestations       
Urinary tract infection  1  6/175 (3.43%)  13 4/50 (8.00%)  7 13/178 (7.30%)  19
Nasophayrngitis  1  7/175 (4.00%)  9 3/50 (6.00%)  3 11/178 (6.18%)  11
Upper respiratory tract infection  1  7/175 (4.00%)  8 1/50 (2.00%)  1 10/178 (5.62%)  13
Sinusitis  1  9/175 (5.14%)  9 3/50 (6.00%)  3 3/178 (1.69%)  3
Bronchitis  1  6/175 (3.43%)  7 3/50 (6.00%)  3 1/178 (0.56%)  1
Injury, poisoning and procedural complications       
Procedural pain  1  7/175 (4.00%)  7 3/50 (6.00%)  4 10/178 (5.62%)  12
Musculoskeletal and connective tissue disorders       
Arthralgia  1  12/175 (6.86%)  14 5/50 (10.00%)  10 17/178 (9.55%)  27
Back pain  1  8/175 (4.57%)  8 3/50 (6.00%)  3 10/178 (5.62%)  13
Myalgia  1  10/175 (5.71%)  18 3/50 (6.00%)  9 3/178 (1.69%)  3
Pain in extremity  1  4/175 (2.29%)  5 3/50 (6.00%)  4 3/178 (1.69%)  4
Muscle spasms  1  1/175 (0.57%)  1 3/50 (6.00%)  4 5/178 (2.81%)  5
Nervous system disorders       
Headache  1  10/175 (5.71%)  14 1/50 (2.00%)  1 9/178 (5.06%)  10
Dizziness  1  10/175 (5.71%)  11 2/50 (4.00%)  2 6/178 (3.37%)  6
Renal and urinary disorders       
Haematuria  1  8/175 (4.57%)  9 4/50 (8.00%)  4 9/178 (5.06%)  9
Dysuria  1  4/175 (2.29%)  4 3/50 (6.00%)  3 3/178 (1.69%)  3
Respiratory, thoracic and mediastinal disorders       
Cough  1  7/175 (4.00%)  7 6/50 (12.00%)  8 3/178 (1.69%)  3
Nasal congestion  1  1/175 (0.57%)  1 3/50 (6.00%)  3 2/178 (1.12%)  2
Epistaxis  1  0/175 (0.00%)  0 3/50 (6.00%)  4 1/178 (0.56%)  1
Vascular disorders       
Hot flush  1  87/175 (49.71%)  91 26/50 (52.00%)  26 110/178 (61.80%)  113
Hypertension  1  12/175 (6.86%)  12 4/50 (8.00%)  4 17/178 (9.55%)  19
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
EMail: DK0-Disclosure@ferring.com
Layout table for additonal information
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00928434    
Other Study ID Numbers: FE200486 CS37
First Submitted: June 25, 2009
First Posted: June 26, 2009
Results First Submitted: May 9, 2016
Results First Posted: December 13, 2016
Last Update Posted: December 13, 2016