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Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00117949
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : June 5, 2009
Last Update Posted : May 23, 2011
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Degarelix
Enrollment 82
Recruitment Details The patients were followed until they met a pre-defined criterion for insufficient testosterone or prostate-specific antigen (PSA).
Pre-assignment Details  
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description Degarelix 40 mg (10 mg/mL) Degarelix 80 mg (20 mg/mL) Degarelix 120 mg (30 mg/mL) Degarelix 160 mg (40 mg/mL)
Period Title: Overall Study
Started 10 [1] 24 24 24
Completed 0 0 0 0
Not Completed 10 24 24 24
Reason Not Completed
Testosterone >1.0 ng/mL             10             18             17             15
Testosterone 0.5 - 1.0 ng/mL             0             1             3             2
Prostate-specific antigen increase >=25%             0             1             1             2
PSA increase >=10ng/mL             0             1             1             0
PSA reduction <=50%             0             2             2             4
Hepatic abnormalities             0             1             0             1
[1]
Dose level terminated prematurely due to inadequate testosterone response
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg Total
Hide Arm/Group Description Degarelix 40 mg (10 mg/mL) Degarelix 80 mg (20 mg/mL) Degarelix 120 mg (30 mg/mL) Degarelix 160 mg (40 mg/mL) Total of all reporting groups
Overall Number of Baseline Participants 10 24 24 24 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  10.0%
1
   4.2%
2
   8.3%
4
  16.7%
8
   9.8%
>=65 years
9
  90.0%
23
  95.8%
22
  91.7%
20
  83.3%
74
  90.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
72.0  (5.7) 77.5  (6.4) 75.9  (5.8) 74.7  (8.4) 75.6  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
24
 100.0%
24
 100.0%
24
 100.0%
82
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
Oriental/Asian 0 0 0 0 0
Black 2 1 2 1 6
Caucasian 5 23 15 20 63
Other 3 0 7 3 13
Gleason score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
Unknown 0 1 0 0 1
2-4 1 1 1 0 3
5-6 3 14 12 13 42
7-10 6 8 11 11 36
[1]
Measure Description: The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.
Stage of prostate cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
Localized 5 11 12 10 38
Locally advanced 0 6 5 5 16
Metastatic 2 4 2 2 10
Not classifiable 3 3 5 7 18
[1]
Measure Description: Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.
Body mass index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
26.70  (5.72) 26.61  (3.55) 27.22  (3.16) 26.64  (3.38) 26.70  (5.72)
[1]
Measure Description: Body mass index is a measure of body fat based on height and weight.
Serum prostate-specific antigen levels  
Median (Full Range)
Unit of measure:  Nanogram per milliliter
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
9.30
(2.3 to 36.3)
13.40
(3.6 to 765)
9.10
(2.2 to 50.9)
6.40
(2.2 to 154)
9.35
(2.2 to 765)
Serum testosterone levels  
Median (Full Range)
Unit of measure:  Nanogram per milliliter
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
3.98
(2.29 to 5.31)
4.10
(1.79 to 8.53)
3.96
(2.02 to 7.22)
3.89
(1.79 to 8.53)
3.93
(1.79 to 8.53)
Time since prostate cancer diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
851  (1077) 954  (1328) 1609  (1836) 1095  (1385) 1181  (1494)
[1]
Measure Description: The mean number of days since a diagnosis of prostate cancer was made for the patients in each study group.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
78.97  (11.73) 81.73  (11.50) 80.77  (12.83) 81.40  (14.36) 81.01  (12.61)
1.Primary Outcome
Title Time to Meet Insufficient Testosterone Response
Hide Description Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who withdrew without meeting the insufficient testosterone (T) suppression criteria were censored as of the time for last available T measurement prior to discontinuation. For the 40 mg group the 95% confidence interval around the time estimate was non-estimable and no statistical analysis is presented (the estimate was 14 days).
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description:
Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg (40 mg/mL)
Overall Number of Participants Analyzed 10 24 24 24
Median (Full Range)
Unit of Measure: days
14
(14 to 70)
77
(14 to 140)
98
(14 to 219)
28
(14 to 126)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Degarelix 40 mg, Degarelix 80 mg, Degarelix 120 mg, Degarelix 160 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Degarelix 80 mg
Comments Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median days to insufficient T response
Estimated Value 84
Confidence Interval 95%
35 to 112
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Degarelix 120 mg
Comments Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median days to insufficient T response
Estimated Value 98
Confidence Interval 95%
70 to 126
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Degarelix 160 mg
Comments Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median days to insufficient T response
Estimated Value 35
Confidence Interval 95%
14 to 98
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days
Hide Description The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description:
Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg (40 mg/mL)
Overall Number of Participants Analyzed 10 24 24 24
Measure Type: Number
Unit of Measure: participants
1 17 19 13
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Degarelix 40 mg, Degarelix 80 mg, Degarelix 120 mg, Degarelix 160 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.181
Comments [Not Specified]
Method Cochran-Armitage Trend Test.
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Degarelix 40 mg
Comments Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 10
Confidence Interval 95%
0.3 to 44.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Degarelix 80 mg
Comments Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 70.8
Confidence Interval 95%
48.9 to 87.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Degarelix 120 mg
Comments Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 79.2
Confidence Interval 95%
57.8 to 92.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Degarelix 160 mg
Comments Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 54.2
Confidence Interval 95%
32.8 to 74.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
Hide Description Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.
Time Frame 1, 3, 7, 14, 21, 28, 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
Half participants in the 40 mg group were not castrated and the median was not calculated (no statistical anaylsis was made). Two participants out of 24 in the 80 mg, 1/24 in the 120 mg, and 3/24 in the 160 mg groups were not castrated. For the 160 mg group the 95% CI was non-estimable and no statistical anaylsis was made.
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description:
Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg (40 mg/mL)
Overall Number of Participants Analyzed 10 24 24 24
Measure Type: Number
Unit of Measure: days
1 day 1 3 11 6
3 days 3 12 12 14
7 days 1 2 0 1
14 days 0 2 0 0
21 days 0 1 0 0
28 days 0 1 0 0
42 days 0 1 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Degarelix 40 mg, Degarelix 80 mg, Degarelix 120 mg, Degarelix 160 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Log Rank
Comments Participants not castrated were censored as of the days from dosing for the last available observation.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Degarelix 80 mg
Comments Kaplan-Meier estimates of the median time to testosterone castration.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median time to castration (days)
Estimated Value 3
Confidence Interval 95%
3 to 7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Degarelix 120 mg
Comments Kaplan-Meier estimates of the time to testosterone castration.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median time to castration (days)
Estimated Value 3
Confidence Interval 95%
1 to 3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days
Hide Description Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description:
Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg (40 mg/mL)
Overall Number of Participants Analyzed 10 24 24 24
Measure Type: Number
Unit of Measure: participants
0 9 14 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Degarelix 40 mg
Comments Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 0
Confidence Interval 95%
0 to 0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Degarelix 80 mg
Comments Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 42.7
Confidence Interval 95%
22 to 63.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Degarelix 120 mg
Comments Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 61.6
Confidence Interval 95%
41.8 to 81.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Degarelix 160 mg
Comments Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 35.6
Confidence Interval 95%
15.8 to 55.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to 50% Reduction in Prostate-specific Antigen Levels
Hide Description The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only two participants reached a 50% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description:
Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg (40 mg/mL)
Overall Number of Participants Analyzed 10 24 24 24
Median (Full Range)
Unit of Measure: days
10.5
(7 to 14)
14
(7 to 42)
14
(7 to 35)
14
(7 to 42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Degarelix 40 mg, Degarelix 80 mg, Degarelix 120 mg, Degarelix 160 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Degarelix 80 mg
Comments Kaplan-Meier estimates of the time (days) to 50% reduction in PSA
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter days
Estimated Value 14
Confidence Interval 95%
14 to 28
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Degarelix 120 mg
Comments Kaplan-Meier estimates of the time (days) to 50% reduction in PSA
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter days
Estimated Value 14
Confidence Interval 95%
14 to 28
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Degarelix 160 mg
Comments Kaplan-Meier estimates of the time (days) to 50% reduction in PSA
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter days
Estimated Value 28
Confidence Interval 95%
14 to 41
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to 90% Reduction in Prostate-specific Antigen Levels
Hide Description The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only one participant reached a 90% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description:
Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg (40 mg/mL)
Overall Number of Participants Analyzed 10 24 24 24
Median (Full Range)
Unit of Measure: days
28
(28 to 28)
35
(28 to 98)
35
(28 to 84)
31.5
(14 to 56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Degarelix 40 mg, Degarelix 80 mg, Degarelix 120 mg, Degarelix 160 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.926
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Degarelix 80 mg
Comments Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter days
Estimated Value 56
Confidence Interval 95%
35 to 56
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Degarelix 120 mg
Comments Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter days
Estimated Value 56
Confidence Interval 95%
35 to 84
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Degarelix 160 mg
Comments Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter days
Estimated Value 56
Confidence Interval 95%
35 to 100
Estimation Comments The upper confidence interval limit could not be calculated. For technical reasons it has been entered as 100.
7.Secondary Outcome
Title Liver Function Tests
Hide Description The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description:
Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg (40 mg/mL)
Overall Number of Participants Analyzed 10 24 24 24
Measure Type: Number
Unit of Measure: participants
Abnormal alanine aminotransferase (ALAT) 0 3 3 6
Abnormal aspartate aminotransferase 1 11 13 9
Abnormal bilirubin 2 0 2 2
ALAT >3x upper limit of normal (ULN) 0 1 0 0
ALAT >3x ULN, bilirubin >1.5x ULN 0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description Degarelix 40 mg (10 mg/mL) Degarelix 80 mg (20 mg/mL) Degarelix 120 mg (30 mg/mL) Degarelix 160 mg (40 mg/mL)
All-Cause Mortality
Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0      1      1      0    
Gastrointestinal disorders         
Small intestinal obstruction  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
General disorders         
Chest pain  1  0/10 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 4.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6      18      20      13    
Blood and lymphatic system disorders         
Anaemia  1  0/10 (0.00%)  0 0/24 (0.00%)  0 3/24 (12.50%)  4 0/24 (0.00%)  0
Eye disorders         
Diabetic retinopathy  1  1/10 (10.00%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea  1  0/10 (0.00%)  0 1/24 (4.17%)  1 2/24 (8.33%)  2 0/24 (0.00%)  0
Constipation  1  0/10 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0
Haemorrhoids  1  0/10 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0
Inguinal hernia  1  0/10 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
General disorders         
Injection site pain  1  0/10 (0.00%)  0 2/24 (8.33%)  2 3/24 (12.50%)  4 1/24 (4.17%)  1
Fatigue  1  1/10 (10.00%)  1 2/24 (8.33%)  2 0/24 (0.00%)  0 2/24 (8.33%)  2
Injection site pruritus  1  0/10 (0.00%)  0 2/24 (8.33%)  2 1/24 (4.17%)  1 0/24 (0.00%)  0
Chest pain  1  0/10 (0.00%)  0 2/24 (8.33%)  4 0/24 (0.00%)  0 0/24 (0.00%)  0
Infections and infestations         
Nasopharyngitis  1  0/10 (0.00%)  0 2/24 (8.33%)  2 3/24 (12.50%)  3 1/24 (4.17%)  1
Investigations         
Alanine aminotransferase increased  1  0/10 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Aspartate aminotransferase increased  1  0/10 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Breath sounds abnormal  1  1/10 (10.00%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  1/10 (10.00%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0
Osteoarthritis  1  1/10 (10.00%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders         
Dizziness  1  1/10 (10.00%)  1 2/24 (8.33%)  2 2/24 (8.33%)  2 1/24 (4.17%)  1
Headache  1  1/10 (10.00%)  1 1/24 (4.17%)  1 2/24 (8.33%)  2 0/24 (0.00%)  0
Psychiatric disorders         
Libido decreased  1  0/10 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2
Renal and urinary disorders         
Dysuria  1  0/10 (0.00%)  0 2/24 (8.33%)  2 1/24 (4.17%)  1 1/24 (4.17%)  1
Urinary retention  1  0/10 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Urine flow decreased  1  1/10 (10.00%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/10 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus  1  0/10 (0.00%)  0 2/24 (8.33%)  3 0/24 (0.00%)  0 0/24 (0.00%)  0
Vascular disorders         
Hot flush  1  2/10 (20.00%)  2 12/24 (50.00%)  12 5/24 (20.83%)  6 5/24 (20.83%)  5
Hypertension  1  0/10 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 4.1
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.
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
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Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00117949    
Other Study ID Numbers: FE200486 CS06
First Submitted: June 30, 2005
First Posted: July 11, 2005
Results First Submitted: January 22, 2009
Results First Posted: June 5, 2009
Last Update Posted: May 23, 2011