ClinicalTrials.gov
ClinicalTrials.gov Menu

Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00268892
Recruitment Status : Completed
First Posted : December 23, 2005
Results First Posted : December 6, 2010
Last Update Posted : December 24, 2010
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Degarelix
Enrollment 278
Recruitment Details Participants who completed the main FE200486 CS15(NCT00113753) study (except those in US and Canada) were asked to continue into the FE200486 CS15A extension study.
Pre-assignment Details 447 participants started and 374 participants completed the main CS15 study. Of these, 278 participants were recruited into the extension study CS15A and 203 participants signed the informed consent for dose shift.
Arm/Group Title Degarelix 240/240@40(1-3-6-9) Degarelix 240/240@60(1-3-6-9) Degarelix 240/240@60(1-4-7-10)
Hide Arm/Group Description Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Period Title: Overall Study
Started 90 95 93
Switched to Higher Dose 59 68 76
Completed 51 53 54
Not Completed 39 42 39
Reason Not Completed
Adverse Event             14             17             20
Lack of Efficacy             1             3             0
Withdrawal by Subject             14             15             13
Physician Decision             0             1             0
Lost to Follow-up             5             2             4
Protocol Violation             0             1             0
Disease Progression             1             1             0
Trial Site Closed             4             2             2
Arm/Group Title Degarelix 240/240@40(1-3-6-9) Degarelix 240/240@60(1-3-6-9) Degarelix 240/240@60(1-4-7-10) Total
Hide Arm/Group Description Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). Total of all reporting groups
Overall Number of Baseline Participants 90 95 93 278
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 95 participants 93 participants 278 participants
72.7  (6.55) 73.3  (7.00) 71.8  (7.05) 72.6  (6.88)
[1]
Measure Description: Safety analysis set.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 95 participants 93 participants 278 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
90
 100.0%
95
 100.0%
93
 100.0%
278
 100.0%
[1]
Measure Description: Safety analysis set.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 95 participants 93 participants 278 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.1%
1
   0.4%
Asian
0
   0.0%
1
   1.1%
1
   1.1%
2
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   3.3%
5
   5.3%
3
   3.2%
11
   4.0%
White
87
  96.7%
89
  93.7%
88
  94.6%
264
  95.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Safety analysis set.
Body Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 90 participants 95 participants 93 participants 278 participants
76.7  (13.0) 76.9  (12.2) 76.5  (12.8) 76.7  (12.6)
[1]
Measure Description: Safety analysis set.
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 90 participants 95 participants 93 participants 278 participants
25.4  (4.14) 25.8  (3.93) 25.8  (4.16) 25.7  (4.07)
[1]
Measure Description: Safety analysis set.
Curative Intent   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 95 participants 93 participants 278 participants
Yes 10 12 7 29
No 80 83 86 249
[1]
Measure Description: Safety analysis set. A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.
Gleason Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 95 participants 93 participants 278 participants
2-4 13 6 13 32
5-6 33 30 34 97
7-10 44 58 46 148
[1]
Measure Description: Safety analysis set. 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. A Gleason Score was missing for one participant in the Degarelix 240/240@60(1-3-6-9) group.
Stage of Prostate Cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 95 participants 93 participants 278 participants
Localized 34 37 36 107
Locally Advanced 26 26 28 80
Metastatic 16 19 20 55
Not Classifiable 14 13 9 36
[1]
Measure Description: Safety analysis set. 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.
Time since Prostate Cancer Diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 90 participants 95 participants 93 participants 278 participants
469  (1079) 347  (824) 255  (583) 356  (852)
[1]
Measure Description: Safety analysis set.
1.Primary Outcome
Title Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Hide Description This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.
Time Frame Baseline and up to 4.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data include data from participants participating in both the main study (FE200486 CS15) and the extension study FE200486 CS15A.
Arm/Group Title Degarelix 240/240@40(1-3-6-9) Degarelix 240/240@60(1-3-6-9) Degarelix 240/240@60(1-4-7-10)
Hide Arm/Group Description:
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Overall Number of Participants Analyzed 90 95 93
Measure Type: Number
Unit of Measure: participants
Diastolic blood pressure <=50 and decrease >=15 5 6 4
Diastolic blood pressure >=105 and increase >=15 7 6 8
Systolic blood pressure <=90 and decrease >=20 1 1 2
Systolic blood pressure >=180 and increase >=20 8 11 10
Heart rate <=50 and decrease >=15 9 10 5
Heart rate >=120 and increase >=15 1 4 1
Body weight decrease of >=7 percent 7 8 4
Body weight increase of >=7 percent 32 35 41
2.Primary Outcome
Title Liver Function Tests
Hide Description The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase 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 4.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Degarelix 240/240@40(1-3-6-9) Degarelix 240/240@60(1-3-6-9) Degarelix 240/240@60(1-4-7-10)
Hide Arm/Group Description:
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Overall Number of Participants Analyzed 90 95 93
Measure Type: Number
Unit of Measure: participants
Abnormal alanine aminotransferase (ALAT) 22 22 17
Abnormal aspartate aminotransferase 18 25 19
Abnormal bilirubin 4 5 3
ALAT >3x upper limit of normal (ULN) 3 2 3
ALAT >3x ULN, bilirubin >1.5x ULN 0 0 0
Time Frame 4.5 years.
Adverse Event Reporting Description Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
 
Arm/Group Title Degarelix 240/240@40(1-3-6-9) Degarelix 240/240@60(1-3-6-9) Degarelix 240/240@60(1-4-7-10)
Hide Arm/Group Description Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
All-Cause Mortality
Degarelix 240/240@40(1-3-6-9) Degarelix 240/240@60(1-3-6-9) Degarelix 240/240@60(1-4-7-10)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Degarelix 240/240@40(1-3-6-9) Degarelix 240/240@60(1-3-6-9) Degarelix 240/240@60(1-4-7-10)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/90 (33.33%)      24/95 (25.26%)      21/93 (22.58%)    
Cardiac disorders       
Myocardial ischaemia  1  1/90 (1.11%)  1 1/95 (1.05%)  1 1/93 (1.08%)  1
Acute myocardial infarction  1  2/90 (2.22%)  2 0/95 (0.00%)  0 0/93 (0.00%)  0
Atrial fibrillation  1  1/90 (1.11%)  1 1/95 (1.05%)  1 0/93 (0.00%)  0
Cardiac Failure  1  1/90 (1.11%)  1 0/95 (0.00%)  0 1/93 (1.08%)  1
Angina Pectoris  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Artrial Flutter  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Atrioventricular block complete  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Cardiac arrest  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Cardio-respiratory arrest  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Coronary artery disease  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Coronary artery stenosis  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Right ventricular failure  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Sick sinus syndrome  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Endocrine disorders       
Hypoparathyroidism  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Eye disorders       
Eye haemorrhage  1  0/90 (0.00%)  0 1/95 (1.05%)  2 0/93 (0.00%)  0
Gastrointestinal disorders       
Constipation  1  0/90 (0.00%)  0 1/95 (1.05%)  1 1/93 (1.08%)  1
Volvulus  1  0/90 (0.00%)  0 1/95 (1.05%)  1 1/93 (1.08%)  1
Vomiting  1  1/90 (1.11%)  1 1/95 (1.05%)  1 0/93 (0.00%)  0
Abdominal pain  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Abdominal pain lower  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Crohn's disease  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Gastritis  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Gastrointestinal haemorrhage  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Gastrointestinal hypomotility  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Gastrointestinal necrosis  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Haematemesis  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Haemorrhoids  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Ileus  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Inguinal hernia  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Intestinal infarction  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Pancreatic cyst  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
General disorders       
Disease progression  1  1/90 (1.11%)  1 0/95 (0.00%)  0 1/93 (1.08%)  1
Pyrexia  1  1/90 (1.11%)  1 1/95 (1.05%)  1 0/93 (0.00%)  0
Adverse drug reaction  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Fatigue  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Sudden death  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Hepatobiliary disorders       
Cholecystitis acute  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Infections and infestations       
Erysipelas  1  0/90 (0.00%)  0 1/95 (1.05%)  1 1/93 (1.08%)  1
Appendicitis  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Cellulitis  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Gastroenteritis  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Mycotoxicosis  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Pneumonia  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Pyelonephritis  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Pyelonephritis acute  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Respiratory tract infection  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Staphylococcal sepsis  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Urinary tract infection  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Injury, poisoning and procedural complications       
Hip fracture  1  3/90 (3.33%)  3 1/95 (1.05%)  1 0/93 (0.00%)  0
Hand fracture  1  1/90 (1.11%)  1 1/95 (1.05%)  1 0/93 (0.00%)  0
Ankle fracture  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Brain contusion  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Femur fracture  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Joint dislocation  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Post procedural haematuria  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Radius fracture  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Rib fracture  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Subdural haematoma  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Ulna fracture  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Investigations       
Blood pressure increased  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Investigation  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Prostatic specific antigen increased  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Osteoarthiritis  1  1/90 (1.11%)  1 1/95 (1.05%)  1 0/93 (0.00%)  0
Arthralgia  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  2
Osteoporotic fracture  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Pathological fracture  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Rhabdomyolysis  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer metastatic  1  2/90 (2.22%)  2 1/95 (1.05%)  1 1/93 (1.08%)  1
Prostate cancer  1  1/90 (1.11%)  1 0/95 (0.00%)  0 2/93 (2.15%)  2
Bladder transitional cell  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Carcinoma  1  0/90 (0.00%)  0 0/95 (0.00%)  0 0/93 (0.00%)  0
Lung neoplasm  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Lymphoma  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Metastates to spine  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Metastatic pain  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Rectal cancer  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Throat cancer  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident  1  0/90 (0.00%)  0 1/95 (1.05%)  1 1/93 (1.08%)  1
Cerebal infarction  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Cerebrovascular disorder  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Dementia Alzheimer's type  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Dizziness  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Haemorrhagic stroke  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Hemiparesis  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Ischaemic stroke  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Paraplegia  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Transient ischaemic attack  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Presyncope  1  0/90 (0.00%)  0 1/95 (1.05%)  2 0/93 (0.00%)  0
Psychiatric disorders       
Agitation  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Confusional state  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Renal and urinary disorders       
Urinary retention  1  7/90 (7.78%)  7 3/95 (3.16%)  3 0/93 (0.00%)  0
Haematuria  1  0/90 (0.00%)  0 2/95 (2.11%)  2 1/93 (1.08%)  1
Hydronephrosis  1  0/90 (0.00%)  0 2/95 (2.11%)  4 1/93 (1.08%)  1
Bladder tamponade  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  1
Calculus ureteric  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Renal colic  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Renal failure acute  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Urethral stenosis  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Urinary bladder polyp  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Urinary incontinence  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/90 (0.00%)  0 0/95 (0.00%)  0 2/93 (2.15%)  2
Pulmonary embolism  1  0/90 (0.00%)  0 1/95 (1.05%)  1 1/93 (1.08%)  1
Cough  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Epistaxis  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Stasis dermatitis  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Vascular disorders       
Arterial disorder  1  0/90 (0.00%)  0 0/95 (0.00%)  0 1/93 (1.08%)  2
Arterial stenosis limb  1  0/90 (0.00%)  0 1/95 (1.05%)  1 0/93 (0.00%)  0
Hypotension  1  1/90 (1.11%)  1 0/95 (0.00%)  0 0/93 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Degarelix 240/240@40(1-3-6-9) Degarelix 240/240@60(1-3-6-9) Degarelix 240/240@60(1-4-7-10)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   72/90 (80.00%)      75/95 (78.95%)      69/93 (74.19%)    
Blood and lymphatic system disorders       
Anaemia  1  5/90 (5.56%)  6 7/95 (7.37%)  7 5/93 (5.38%)  6
Cardiac disorders       
Atrial Fibrillation  1  7/90 (7.78%)  12 9/95 (9.47%)  14 6/93 (6.45%)  6
Eye disorders       
Cataract  1  6/90 (6.67%)  8 1/95 (1.05%)  1 3/93 (3.23%)  3
Gastrointestinal disorders       
Abdominal Pain  1  7/90 (7.78%)  10 6/95 (6.32%)  7 4/93 (4.30%)  4
Nausea  1  5/90 (5.56%)  6 10/95 (10.53%)  15 2/93 (2.15%)  2
Constipation  1  4/90 (4.44%)  4 6/95 (6.32%)  6 3/93 (3.23%)  8
Diarrhoea  1  4/90 (4.44%)  4 4/95 (4.21%)  6 5/93 (5.38%)  8
Vomiting  1  3/90 (3.33%)  4 5/95 (5.26%)  8 1/93 (1.08%)  5
General disorders       
Injection Site Pain  1  24/90 (26.67%)  55 24/95 (25.26%)  64 16/93 (17.20%)  36
Injection Site Erythema  1  15/90 (16.67%)  29 14/95 (14.74%)  32 6/93 (6.45%)  8
Pyrexia  1  12/90 (13.33%)  31 9/95 (9.47%)  20 7/93 (7.53%)  22
Fatigue  1  10/90 (11.11%)  13 9/95 (9.47%)  14 8/93 (8.60%)  8
Injection Site Swelling  1  5/90 (5.56%)  12 10/95 (10.53%)  26 3/93 (3.23%)  3
Injection Site Induration  1  7/90 (7.78%)  7 4/95 (4.21%)  5 4/93 (4.30%)  8
Oedema Peripheral  1  4/90 (4.44%)  4 6/95 (6.32%)  6 4/93 (4.30%)  4
Injection Site Nodule  1  6/90 (6.67%)  8 3/95 (3.16%)  7 4/93 (4.30%)  6
Injection Site Mass  1  5/90 (5.56%)  10 2/95 (2.11%)  2 1/93 (1.08%)  1
Injection Site Pruritus  1  5/90 (5.56%)  6 2/95 (2.11%)  3 1/93 (1.08%)  7
Urinary Tract Infection  1  6/90 (6.67%)  8 9/95 (9.47%)  17 6/93 (6.45%)  6
Nasopharyngitis  1  5/90 (5.56%)  10 9/95 (9.47%)  16 3/93 (3.23%)  5
Influenza  1  4/90 (4.44%)  4 5/95 (5.26%)  5 7/93 (7.53%)  9
Aspartate Aminotransferase Increase  1  4/90 (4.44%)  4 3/95 (3.16%)  4 5/93 (5.38%)  5
Investigations       
Weight Increased  1  11/90 (12.22%)  12 9/95 (9.47%)  10 7/93 (7.53%)  7
Alanine Aminotransferase Increased  1  6/90 (6.67%)  6 5/95 (5.26%)  6 5/93 (5.38%)  5
Weight Decreased  1  4/90 (4.44%)  4 7/95 (7.37%)  7 4/93 (4.30%)  4
Musculoskeletal and connective tissue disorders       
Arthralgia  1  10/90 (11.11%)  13 7/95 (7.37%)  10 6/93 (6.45%)  14
Back Pain  1  9/90 (10.00%)  10 5/95 (5.26%)  7 6/93 (6.45%)  12
Musculoskeletal Pain  1  5/90 (5.56%)  5 1/95 (1.05%)  2 3/93 (3.23%)  6
Nervous system disorders       
Dizziness  1  7/90 (7.78%)  9 9/95 (9.47%)  12 4/93 (4.30%)  6
Headache  1  5/90 (5.56%)  7 4/95 (4.21%)  4 3/93 (3.23%)  20
Psychiatric disorders       
Insomnia  1  2/90 (2.22%)  3 7/95 (7.37%)  7 1/93 (1.08%)  1
Renal and urinary disorders       
Urinary retention  1  2/90 (2.22%)  2 5/95 (5.26%)  6 2/93 (2.15%)  2
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  2/90 (2.22%)  3 5/95 (5.26%)  5 3/93 (3.23%)  4
Rash  1  1/90 (1.11%)  3 5/95 (5.26%)  9 0/93 (0.00%)  0
Vascular disorders       
Hot Flush  1  31/90 (34.44%)  33 27/95 (28.42%)  29 32/93 (34.41%)  38
Hypertension  1  4/90 (4.44%)  5 6/95 (6.32%)  6 5/93 (5.38%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
Results Point of Contact
Name/Title: Ferring Pharmaceuticals
Organization: Clinical Development Support
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00268892     History of Changes
Other Study ID Numbers: FE200486 CS15A
First Submitted: December 21, 2005
First Posted: December 23, 2005
Results First Submitted: November 17, 2010
Results First Posted: December 6, 2010
Last Update Posted: December 24, 2010