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An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in 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: NCT00215683
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : December 14, 2010
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
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 137
Recruitment Details Participants who completed the main FE200486 CS12 study were asked to continue into the FE200486 CS12A extension study.
Pre-assignment Details 189 participants were randomized into the main study CS12 and 147 patients completed CS12. Of these, 137 participants were recruited into the extension study CS12A and 109 participants signed the informed consent for dose shift.
Arm/Group Title Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Period Title: Overall Study
Started 45 [1] 48 44
Switched to 160 mg 32 [2] 41 36
Completed 16 [3] 22 12
Not Completed 29 26 32
Reason Not Completed
Adverse Event             15             16             15
Lack of Efficacy             5             1             2
Lost to Follow-up             0             2             1
Withdrawal by Subject             9             4             13
Physician Decision             0             0             1
Difficult to attend visits             0             1             0
No study drug available             0             1             0
Intermittent therapy required             0             1             0
[1]
Safety analysis set
[2]
A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all participants
[3]
Participants ongoing at the time of study closure were considered to have completed the study
Arm/Group Title Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg Total
Hide Arm/Group Description Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. Total of all reporting groups
Overall Number of Baseline Participants 45 48 44 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 48 participants 44 participants 137 participants
71.0  (7.9) 70.8  (6.3) 72.4  (7.7) 71.4  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 48 participants 44 participants 137 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
45
 100.0%
48
 100.0%
44
 100.0%
137
 100.0%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 48 participants 44 participants 137 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.1%
0
   0.0%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
   6.3%
0
   0.0%
3
   2.2%
White
45
 100.0%
44
  91.7%
44
 100.0%
133
  97.1%
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 45 participants 48 participants 44 participants 137 participants
79.4  (15.9) 79.1  (13.2) 76.8  (12.4) 78.4  (13.9)
[1]
Measure Description: Safety analysis set
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 45 participants 48 participants 44 participants 137 participants
26.4  (4.5) 26.4  (3.4) 25.7  (3.4) 26.2  (3.8)
[1]
Measure Description: Safety analysis set
Curative Intent   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 48 participants 44 participants 137 participants
Yes 3 3 3 9
No 42 45 41 128
[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 45 participants 48 participants 44 participants 137 participants
2-4 10 11 5 26
5-6 18 22 16 56
7-10 17 15 22 54
[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. Gleason score for one patient in 160 mg group was missing.
Stage of Prostate Cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 48 participants 44 participants 137 participants
Localized 10 14 8 32
Locally advanced 16 15 18 49
Metastatic 5 7 6 18
Not classifiable 14 12 12 38
[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 45 participants 48 participants 44 participants 137 participants
355  (645) 227  (590) 457  (1086) 343  (798)
[1]
Measure Description: Safety analysis set.
1.Primary Outcome
Title Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Hide Description Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.
Arm/Group Title Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description:
Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Overall Number of Participants Analyzed 45 48 44
Measure Type: Number
Unit of Measure: participants
Diastolic blood pressure <=50 and decrease >=15 3 5 10
Diastolic blood pressure >=105 and increase >=15 9 5 9
Systolic blood pressure <=90 and decrease >=20 1 2 2
Systolic blood pressure >=180 and increase >=20 4 9 8
Heart rate <=50 and decrease >=15 3 5 5
Heart rate >=120 and increase >=15 1 1 0
Body weight decrease of >=7 percent 4 10 8
Body weight increase of >=7 percent 18 19 14
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 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.
Arm/Group Title Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description:
Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Overall Number of Participants Analyzed 45 48 44
Measure Type: Number
Unit of Measure: participants
Abnormal alanine aminotransferase (ALAT) 19 18 23
Abnormal aspartate aminotransferase 18 23 21
Abnormal bilirubin 8 11 3
ALAT >3x upper limit of normal (ULN) 3 3 3
ALAT >3x ULN, bilirubin >1.5x ULN 0 0 0
Time Frame 5 years
Adverse Event Reporting Description Each patient'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 patient's Case Report Form.
 
Arm/Group Title Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
All-Cause Mortality
Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/45 (42.22%)      20/48 (41.67%)      10/44 (22.73%)    
Blood and lymphatic system disorders       
Anaemia  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Cardiac disorders       
Angina pectoris  1  2/45 (4.44%)  2 0/48 (0.00%)  0 0/44 (0.00%)  0
Atrial fibrillation  1  1/45 (2.22%)  1 1/48 (2.08%)  1 0/44 (0.00%)  0
Cardiopulmonary failure  1  1/45 (2.22%)  1 0/48 (0.00%)  0 1/44 (2.27%)  1
Ventricular tachycardia  1  1/45 (2.22%)  10 0/48 (0.00%)  0 1/44 (2.27%)  1
Acute myocardial infarction  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Atrioventricular block  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Cardiac failure  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Cardiac failure acute  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Myocardial infarction  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Supraventricular tachycardia  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Tachyarrhythmia  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Atrioventricular block complete  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Eye disorders       
Corneal defect  1  0/45 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  1
Neurotrophic keratopathy  1  0/45 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  1
Ulcerative keratitis  1  0/45 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  8
Gastrointestinal disorders       
Ileus  1  0/45 (0.00%)  0 2/48 (4.17%)  2 0/44 (0.00%)  0
Diarrhoea  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Gastrointestinal haemorrhage  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Inguinal hernia  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Peritonitis  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Subileus  1  0/45 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  1
Gastroenteritis  1  0/45 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  1
General disorders       
Disease progression  1  1/45 (2.22%)  1 1/48 (2.08%)  1 0/44 (0.00%)  0
Oedema peripheral  1  0/45 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  1
Hepatobiliary disorders       
Hepatic cirrhosis  1  0/45 (0.00%)  0 0/48 (0.00%)  0 0/44 (0.00%)  0
Hepatic failure  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Jaundice cholestatic  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Infections and infestations       
Appendicitis perforated  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Pneumonia  1  0/45 (0.00%)  0 4/48 (8.33%)  5 1/44 (2.27%)  1
Bronchitis  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Bronchopneumonia  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Gastroenteritis viral  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Sepsis  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Urinary tract infection  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Injury, poisoning and procedural complications       
Femoral neck fracture  1  2/45 (4.44%)  2 0/48 (0.00%)  0 0/44 (0.00%)  0
Spinal compression fracture  1  1/45 (2.22%)  1 1/48 (2.08%)  1 0/44 (0.00%)  0
Investigations       
Angiogram  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Blood potassium increased  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Diabetes mellitus inadequate control  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  2/45 (4.44%)  3 1/48 (2.08%)  1 0/44 (0.00%)  0
Arthralgia  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Groin pain  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Intravertebral disc compression  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Muscular weakness  1  0/45 (0.00%)  0 1/48 (2.08%)  2 0/44 (0.00%)  0
Pain in extremity  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Acoustic neuroma  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastases to bone  1  1/45 (2.22%)  1 3/48 (6.25%)  3 1/44 (2.27%)  1
Metastases to liver  1  2/45 (4.44%)  2 0/48 (0.00%)  0 0/44 (0.00%)  0
Benign colonic neoplasm  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Brain neoplasm  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Bronchial carcinoma  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Carcinoma in situ of eye  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Colon cancer  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Colorectal cancer  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Lung neoplasm  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Lung neoplasm malignant  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Lymphangiosis carcinomatosa  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Metastasis  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Metastatic neoplasm  1  0/45 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  1
Pancreatic carcinoma  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Renal cell carcinoma stage I  1  0/45 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  1
Paraparesis  1  0/45 (0.00%)  0 1/48 (2.08%)  2 0/44 (0.00%)  0
Post polio syndrome  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Nervous system disorders       
Cerebovascular accident  1  3/45 (6.67%)  3 2/48 (4.17%)  2 1/44 (2.27%)  1
Transient ischaemic attack  1  1/45 (2.22%)  1 0/48 (0.00%)  0 1/44 (2.27%)  1
Aphasia  1  0/45 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  1
Cerebral circulatory failure  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Cerebral infarction  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Monoplegia  1  0/45 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  2
Neuralgia  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Sciatica  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Spinal cord compression  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Psychiatric disorders       
Confusional state  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Depression  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Renal and urinary disorders       
Urinary retention  1  1/45 (2.22%)  1 1/48 (2.08%)  1 2/44 (4.55%)  2
Hydronephrosis  1  2/45 (4.44%)  2 0/48 (0.00%)  0 0/44 (0.00%)  0
Urethral obstruction  1  1/45 (2.22%)  1 1/48 (2.08%)  3 0/44 (0.00%)  0
Anuria  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Bladder neck obstruction  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Bladder obstruction  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Bladder tamponade  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Haematuria  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Renal failure  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  2/45 (4.44%)  2 0/48 (0.00%)  0 0/44 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/45 (2.22%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0
Haemoptysis  1  0/45 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  1
Skin and subcutaneous tissue disorders       
Skin ulcer  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Vascular disorders       
Hypertension  1  0/45 (0.00%)  0 1/48 (2.08%)  1 1/44 (2.27%)  2
Femoral artery occlusion  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Lymphoedema  1  0/45 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/45 (77.78%)      41/48 (85.42%)      38/44 (86.36%)    
Blood and lymphatic system disorders       
Anaemia  1  3/45 (6.67%)  6 1/48 (2.08%)  1 2/44 (4.55%)  2
Cardiac disorders       
Atrial fibrillation  1  1/45 (2.22%)  1 4/48 (8.33%)  5 1/44 (2.27%)  1
Atrioventricular block first degree  1  3/45 (6.67%)  3 3/48 (6.25%)  3 0/44 (0.00%)  0
Myocardial ischaemia  1  2/45 (4.44%)  2 2/48 (4.17%)  2 2/44 (4.55%)  2
Bradycardia  1  0/45 (0.00%)  0 1/48 (2.08%)  1 2/44 (4.55%)  2
Ventricular extrasystoles  1  0/45 (0.00%)  0 4/48 (8.33%)  4 0/44 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  0/45 (0.00%)  0 0/48 (0.00%)  0 2/44 (4.55%)  3
Eye disorders       
Cataract  1  2/45 (4.44%)  4 2/48 (4.17%)  4 3/44 (6.82%)  4
Gastrointestinal disorders       
Constipation  1  7/45 (15.56%)  9 2/48 (4.17%)  3 2/44 (4.55%)  2
Diarrhoea  1  3/45 (6.67%)  6 5/48 (10.42%)  5 6/44 (13.64%)  7
Nausea  1  5/45 (11.11%)  7 1/48 (2.08%)  2 4/44 (9.09%)  4
Abdominal pain  1  2/45 (4.44%)  2 1/48 (2.08%)  1 2/44 (4.55%)  3
Dyspepsia  1  1/45 (2.22%)  1 3/48 (6.25%)  3 0/44 (0.00%)  0
General disorders       
Injection site pain  1  6/45 (13.33%)  28 11/48 (22.92%)  22 13/44 (29.55%)  48
Fatigue  1  6/45 (13.33%)  8 3/48 (6.25%)  7 6/44 (13.64%)  9
Pyrexia  1  6/45 (13.33%)  7 3/48 (6.25%)  6 6/44 (13.64%)  11
Injection site erythema  1  3/45 (6.67%)  4 2/48 (4.17%)  4 9/44 (20.45%)  15
Injection site nodule  1  3/45 (6.67%)  7 5/48 (10.42%)  6 5/44 (11.36%)  5
Injection site swelling  1  0/45 (0.00%)  0 4/48 (8.33%)  9 6/44 (13.64%)  13
Oedema peripheral  1  4/45 (8.89%)  6 4/48 (8.33%)  6 2/44 (4.55%)  4
Asthenia  1  4/45 (8.89%)  4 2/48 (4.17%)  2 2/44 (4.55%)  2
Injection site inflammation  1  1/45 (2.22%)  1 3/48 (6.25%)  3 4/44 (9.09%)  4
Chest pain  1  1/45 (2.22%)  1 1/48 (2.08%)  1 2/44 (4.55%)  2
Hyperthermia  1  0/45 (0.00%)  0 1/48 (2.08%)  1 2/44 (4.55%)  2
Injection site haematoma  1  1/45 (2.22%)  1 0/48 (0.00%)  0 2/44 (4.55%)  2
Injection site reaction  1  0/45 (0.00%)  0 0/48 (0.00%)  0 3/44 (6.82%)  4
Infections and infestations       
Influenza  1  6/45 (13.33%)  8 9/48 (18.75%)  15 8/44 (18.18%)  9
Urinary tract infection  1  4/45 (8.89%)  6 6/48 (12.50%)  11 4/44 (9.09%)  4
Bronchitis  1  4/45 (8.89%)  4 2/48 (4.17%)  2 5/44 (11.36%)  8
Nasopharyngitis  1  2/45 (4.44%)  7 2/48 (4.17%)  4 4/44 (9.09%)  8
Pneumonia  1  3/45 (6.67%)  3 2/48 (4.17%)  3 3/44 (6.82%)  3
Gastroenteritis  1  2/45 (4.44%)  2 3/48 (6.25%)  3 2/44 (4.55%)  2
Rhinitis  1  1/45 (2.22%)  1 0/48 (0.00%)  0 4/44 (9.09%)  5
Upper respiratory tract infection  1  0/45 (0.00%)  0 4/48 (8.33%)  5 1/44 (2.27%)  1
Investigations       
Prostatic specific antigen increased  1  11/45 (24.44%)  12 8/48 (16.67%)  10 7/44 (15.91%)  9
Weight increased  1  7/45 (15.56%)  7 9/48 (18.75%)  10 7/44 (15.91%)  7
Weight decreased  1  3/45 (6.67%)  3 7/48 (14.58%)  9 8/44 (18.18%)  8
Blood alkaline phosphatase increased  1  1/45 (2.22%)  1 3/48 (6.25%)  3 5/44 (11.36%)  7
Blood urea increased  1  2/45 (4.44%)  4 2/48 (4.17%)  2 5/44 (11.36%)  5
Alanine aminotransferase increased  1  2/45 (4.44%)  2 3/48 (6.25%)  6 3/44 (6.82%)  5
Gamma-glutamyltransferase increased  1  3/45 (6.67%)  3 2/48 (4.17%)  3 3/44 (6.82%)  5
Blood creatinine increased  1  2/45 (4.44%)  3 1/48 (2.08%)  1 3/44 (6.82%)  3
Aspartate aminotransferase increased  1  2/45 (4.44%)  2 1/48 (2.08%)  4 2/44 (4.55%)  3
Platelet count decreased  1  1/45 (2.22%)  1 0/48 (0.00%)  0 2/44 (4.55%)  3
Metabolism and nutrition disorders       
Hypercholesterolaemia  1  2/45 (4.44%)  2 0/48 (0.00%)  0 2/44 (4.55%)  2
Hyperkalaemia  1  2/45 (4.44%)  2 0/48 (0.00%)  0 2/44 (4.55%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  3/45 (6.67%)  9 6/48 (12.50%)  8 9/44 (20.45%)  24
Back pain  1  6/45 (13.33%)  9 7/48 (14.58%)  7 5/44 (11.36%)  5
Pain in extremity  1  5/45 (11.11%)  7 3/48 (6.25%)  4 3/44 (6.82%)  6
Muscle spasms  1  3/45 (6.67%)  5 2/48 (4.17%)  2 3/44 (6.82%)  3
Musculoskeletal pain  1  5/45 (11.11%)  7 1/48 (2.08%)  1 1/44 (2.27%)  1
Osteoarthritis  1  2/45 (4.44%)  2 1/48 (2.08%)  1 3/44 (6.82%)  5
Mylagia  1  1/45 (2.22%)  1 0/48 (0.00%)  0 4/44 (9.09%)  5
Joint swelling  1  1/45 (2.22%)  2 1/48 (2.08%)  1 2/44 (4.55%)  2
Muscular weakness  1  3/45 (6.67%)  4 1/48 (2.08%)  2 0/44 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastases to bone  1  2/45 (4.44%)  2 1/48 (2.08%)  1 2/44 (4.55%)  2
Basal cell carcinoma  1  0/45 (0.00%)  0 0/48 (0.00%)  0 2/44 (4.55%)  2
Nervous system disorders       
Dizziness  1  1/45 (2.22%)  1 5/48 (10.42%)  8 3/44 (6.82%)  3
Headache  1  3/45 (6.67%)  3 0/48 (0.00%)  0 2/44 (4.55%)  4
Psychiatric disorders       
Insomnia  1  2/45 (4.44%)  2 4/48 (8.33%)  4 4/44 (9.09%)  5
Anxiety  1  1/45 (2.22%)  1 1/48 (2.08%)  1 3/44 (6.82%)  3
Depression  1  2/45 (4.44%)  2 0/48 (0.00%)  0 3/44 (6.82%)  3
Renal and urinary disorders       
Haematuria  1  4/45 (8.89%)  4 0/48 (0.00%)  0 5/44 (11.36%)  7
Nocturia  1  3/45 (6.67%)  3 1/48 (2.08%)  1 1/44 (2.27%)  2
Urinary retention  1  1/45 (2.22%)  1 3/48 (6.25%)  3 1/44 (2.27%)  1
Dysuria  1  1/45 (2.22%)  1 3/48 (6.25%)  3 0/44 (0.00%)  0
Pollakiuria  1  1/45 (2.22%)  1 1/48 (2.08%)  1 2/44 (4.55%)  2
Renal collic  1  1/45 (2.22%)  1 0/48 (0.00%)  0 2/44 (4.55%)  2
Reproductive system and breast disorders       
Erectile dysfunction  1  3/45 (6.67%)  4 1/48 (2.08%)  1 3/44 (6.82%)  3
Prostatism  1  3/45 (6.67%)  4 0/48 (0.00%)  0 2/44 (4.55%)  2
Gynaecomastia  1  3/45 (6.67%)  3 0/48 (0.00%)  0 1/44 (2.27%)  1
Dyspnoea  1  3/45 (6.67%)  3 3/48 (6.25%)  4 3/44 (6.82%)  4
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/45 (6.67%)  4 2/48 (4.17%)  3 8/44 (18.18%)  11
Oropharyngeal pain  1  1/45 (2.22%)  2 1/48 (2.08%)  1 2/44 (4.55%)  2
Rales  1  0/45 (0.00%)  0 2/48 (4.17%)  2 2/44 (4.55%)  2
Epistaxis  1  0/45 (0.00%)  0 0/48 (0.00%)  0 2/44 (4.55%)  3
Skin and subcutaneous tissue disorders       
Rash  1  3/45 (6.67%)  3 2/48 (4.17%)  2 3/44 (6.82%)  9
Pruritus  1  3/45 (6.67%)  4 1/48 (2.08%)  1 1/44 (2.27%)  1
Hyperhidrosis  1  1/45 (2.22%)  2 0/48 (0.00%)  0 2/44 (4.55%)  3
Alopecia  1  1/45 (2.22%)  1 3/48 (6.25%)  3 3/44 (6.82%)  3
Vascular disorders       
Hot flush  1  19/45 (42.22%)  27 18/48 (37.50%)  18 17/44 (38.64%)  20
Hypertension  1  3/45 (6.67%)  3 3/48 (6.25%)  3 3/44 (6.82%)  4
Orthostatic hypertension  1  0/45 (0.00%)  0 0/48 (0.00%)  0 2/44 (4.55%)  2
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.
Results Point of Contact
Name/Title: Ferring Pharmaceuticals
Organization: Clinical Development Support
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00215683     History of Changes
Other Study ID Numbers: FE200486 CS12A
First Submitted: September 20, 2005
First Posted: September 22, 2005
Results First Submitted: November 12, 2010
Results First Posted: December 14, 2010
Last Update Posted: April 1, 2015