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Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT00245466
Recruitment Status : Terminated (The maintenance doses were too low to maintain testosterone suppression)
First Posted : October 28, 2005
Results First Posted : June 11, 2009
Last Update Posted : May 20, 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 88
Recruitment Details Participants who responded to degarelix in FE200486 CS02 (NCT00819247) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available in the UK or until the study was discontinued.
Pre-assignment Details  
Arm/Group Title Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20
Hide Arm/Group Description In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
Period Title: Overall Study
Started 43 46 40
Started FE200486 CS02A 32 30 26
Completed 7 [1] 2 3
Not Completed 36 44 37
Reason Not Completed
Adverse Event             2             8             4
Low prostate specific antigen suppr             16             14             5
Insufficient testosterone suppr             12             12             21
Insufficient PSA and testosterone suppr             0             0             3
Withdrawal by Subject             2             2             1
Lost to Follow-up             3             0             0
Disease progression             0             3             1
Protocol Violation             1             2             2
Death             0             2             0
Administrative reasons             0             1             0
[1]
Defined as those participants ongoing when the extension study was terminated
Arm/Group Title Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20 Total
Hide Arm/Group Description In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 43 46 40 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 46 participants 40 participants 129 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  14.0%
5
  10.9%
7
  17.5%
18
  14.0%
>=65 years
37
  86.0%
41
  89.1%
33
  82.5%
111
  86.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 46 participants 40 participants 129 participants
72.4  (6.60) 73.7  (7.22) 71.8  (7.08) 72.7  (6.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 46 participants 40 participants 129 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
43
 100.0%
46
 100.0%
40
 100.0%
129
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 46 participants 40 participants 129 participants
Black 1 3 1 5
White 42 43 37 122
Indian 0 0 1 1
Afro-Carribean 0 0 1 1
Gleason score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 46 participants 40 participants 129 participants
Unknown 1 1 1 3
2-4 3 4 2 9
5-6 11 7 11 29
7-10 28 34 26 88
[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.
Number of Participants With Curative Intent   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 46 participants 40 participants 129 participants
Yes 0 2 1 3
No 43 44 39 126
[1]
Measure Description: A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.
Number of Participants at Each Stage of Prostate Cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 46 participants 40 participants 129 participants
Localized 8 9 5 22
Locally advanced 21 21 18 60
Metastatic 11 14 17 42
Not classifiable 3 2 0 5
[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 43 participants 46 participants 40 participants 129 participants
26.6  (4.15) 26.6  (4.06) 25.9  (3.93) 26.4  (3.93)
[1]
Measure Description: Body mass index is a measure of body fat based on height and weight.
Serum testosterone levels  
Median (Inter-Quartile Range)
Unit of measure:  Nanogram per milliliter
Number Analyzed 43 participants 46 participants 40 participants 129 participants
3.74
(3.08 to 4.94)
4.11
(3.32 to 5.73)
4.70
(3.54 to 5.77)
3.98
(3.21 to 5.53)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 43 participants 46 participants 40 participants 129 participants
77.6  (11.4) 78.5  (14.2) 76.3  (9.78) 77.5  (12.0)
1.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 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The data include patients from both the main study (FE200486 CS02) and the extension study FE200486 CS02A.
Arm/Group Title Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20
Hide Arm/Group Description:
In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
Overall Number of Participants Analyzed 43 46 40
Measure Type: Number
Unit of Measure: participants
Abnormal alanine aminotransferase (ALAT) 18 16 16
Abnormal aspartate aminotransferase 23 22 17
Abnormal bilirubin 3 4 5
ALAT >3x ULN 2 2 1
ALAT >3x ULN, bilirubin >1.5x ULN 0 0 1
2.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 patients in each group with normal baseline and markedly abnormal value post-baseline.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
These data include patients from the main study (FE200486 CS02) and the extension study (FE200486 CS02A).
Arm/Group Title Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20
Hide Arm/Group Description:
In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
Overall Number of Participants Analyzed 43 46 40
Measure Type: Number
Unit of Measure: participants
Diastolic blood pressure <=50 and decrease >=15 1 0 2
Diastolic blood pressure >=105 and increase >=15 0 2 0
Systolic blood pressure <=90 and decrease >=20 0 0 0
Systolic blood pressure >=180 and increase >=20 8 7 1
Heart rate <=50 and decrease >=15 0 1 2
Heart rate >=120 and increase >=15 0 0 0
Body weight decrease of >=7 percent 5 4 5
Body weight increase of >=7 percent 17 14 15
3.Secondary Outcome
Title Serum Levels of Testosterone After 1, 2, and 3 Years
Hide Description [Not Specified]
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20
Hide Arm/Group Description:
In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
Overall Number of Participants Analyzed 43 46 40
Median (Full Range)
Unit of Measure: nanogram per milliliter
1 year (n=25,17,14)
0.120
(0.025 to 0.345)
0.086
(0.025 to 0.372)
0.170
(0.025 to 0.680)
2 years (n=16,9,8)
0.143
(0.025 to 0.805)
0.133
(0.025 to 0.557)
0.305
(0.064 to 0.454)
3 years (n=8,5,6)
0.104
(0.050 to 0.171)
0.132
(0.025 to 0.220)
0.198
(0.050 to 0.391)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20
Hide Arm/Group Description In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
All-Cause Mortality
Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10      14      10    
Blood and lymphatic system disorders       
Anaemia  1  1/43 (2.33%)  1 1/46 (2.17%)  1 0/40 (0.00%)  0
Cardiac disorders       
Cardio-respiratory arrest  1  1/43 (2.33%)  1 1/46 (2.17%)  1 0/40 (0.00%)  0
Angina unstable  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Atrial fibrillation  1  0/43 (0.00%)  0 0/46 (0.00%)  0 1/40 (2.50%)  1
Cardiac failure  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/40 (0.00%)  0
Angina pectoris  1  1/43 (2.33%)  1 0/46 (0.00%)  0 1/40 (2.50%)  1
Myocardial infarction  1  1/43 (2.33%)  1 1/46 (2.17%)  1 0/40 (0.00%)  0
Cardiac failure congestive  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/40 (0.00%)  0
Gastrointestinal disorders       
Abdominal discomfort  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/40 (0.00%)  0
Constipation  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Diarrhoea  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/40 (0.00%)  0
Dysphagia  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Nausea  1  0/43 (0.00%)  0 1/46 (2.17%)  2 0/40 (0.00%)  0
Rectal haemorrhage  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Vomiting  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
General disorders       
Chest pain  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Asthenia  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Catheter related complication  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Condition aggravated  1  0/43 (0.00%)  0 0/46 (0.00%)  0 1/40 (2.50%)  1
Hepatobiliary disorders       
Hepatic function abnormal  1  0/43 (0.00%)  0 0/46 (0.00%)  0 1/40 (2.50%)  1
Immune system disorders       
Hypersensitivity  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Infections and infestations       
Bronchiectasis  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Cellulitis  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/40 (0.00%)  0
Diverticulitis  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Gastroenteritis  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/40 (0.00%)  0
Urinary tract infection  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Lobar pneumonia  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Sepsis  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Injury, poisoning and procedural complications       
Femoral neck fracture  1  1/43 (2.33%)  1 0/46 (0.00%)  0 1/40 (2.50%)  1
Cardiac function disturbance postoperative  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/40 (0.00%)  0
Lumbar vertebral fracture  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Pelvic fracture  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Subdural haematoma  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Post procedural haemorrhage  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Metabolism and nutrition disorders       
Hypercalcaemia  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscular weakness  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Arthraligia  1  0/43 (0.00%)  0 0/46 (0.00%)  0 1/40 (2.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  0/43 (0.00%)  0 0/46 (0.00%)  0 1/40 (2.50%)  1
Metastatic neoplasm  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Lung neoplasm malignant  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident  1  2/43 (4.65%)  2 0/46 (0.00%)  0 1/40 (2.50%)  1
Grand mal convulsion  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Hemiparesis  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/40 (0.00%)  0
Lethargy  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Parkinson's disease  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Syncope vasovagal  1  0/43 (0.00%)  0 1/46 (2.17%)  2 0/40 (0.00%)  0
Cerebral haemorrhage  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Syncope  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Psychiatric disorders       
Confusional state  1  1/43 (2.33%)  2 1/46 (2.17%)  1 0/40 (0.00%)  0
Depression  1  1/43 (2.33%)  1 0/46 (0.00%)  0 1/40 (2.50%)  1
Alcoholism  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/40 (0.00%)  0
Renal and urinary disorders       
Urinary retention  1  1/43 (2.33%)  1 0/46 (0.00%)  0 1/40 (2.50%)  1
Bladder obstruction  1  0/43 (0.00%)  0 0/46 (0.00%)  0 1/40 (2.50%)  1
Calculus bladder  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Dysuria  1  0/43 (0.00%)  0 0/46 (0.00%)  0 1/40 (2.50%)  1
Urine flow decreased  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/43 (0.00%)  0 3/46 (6.52%)  5 0/40 (0.00%)  0
Alveolitis fibrosing  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/40 (0.00%)  0
Dyspnoea exertional  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Pulmonary embolism  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Social circumstances       
Convalescent  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/40 (0.00%)  0
Surgical and medical procedures       
Suprapubic catheter insertion  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 4.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42      40      35    
Blood and lymphatic system disorders       
Anaemia  1  2/43 (4.65%)  2 3/46 (6.52%)  3 2/40 (5.00%)  2
Cardiac disorders       
Atrial fibrillation  1  0/43 (0.00%)  0 3/46 (6.52%)  3 1/40 (2.50%)  1
Gastrointestinal disorders       
Constipation  1  5/43 (11.63%)  5 5/46 (10.87%)  6 3/40 (7.50%)  3
Diarrhoea  1  9/43 (20.93%)  17 3/46 (6.52%)  3 3/40 (7.50%)  6
Dyspepsia  1  1/43 (2.33%)  4 3/46 (6.52%)  3 3/40 (7.50%)  3
Abdominal distension  1  0/43 (0.00%)  0 3/46 (6.52%)  3 0/40 (0.00%)  0
Nausea  1  4/43 (9.30%)  5 5/46 (10.87%)  6 1/40 (2.50%)  1
Inguinal hernia  1  2/43 (4.65%)  2 1/46 (2.17%)  1 2/40 (5.00%)  3
Abdominal pain  1  1/43 (2.33%)  1 0/46 (0.00%)  0 3/40 (7.50%)  3
General disorders       
Oedema peripheral  1  4/43 (9.30%)  4 7/46 (15.22%)  9 1/40 (2.50%)  2
Influenza like illness  1  3/43 (6.98%)  8 2/46 (4.35%)  2 2/40 (5.00%)  2
Malaise  1  3/43 (6.98%)  4 0/46 (0.00%)  0 0/40 (0.00%)  0
Fatigue  1  2/43 (4.65%)  3 4/46 (8.70%)  5 0/40 (0.00%)  0
Pyrexia  1  3/43 (6.98%)  4 1/46 (2.17%)  1 0/40 (0.00%)  0
Suprapubic pain  1  0/43 (0.00%)  0 0/46 (0.00%)  0 2/40 (5.00%)  2
Infections and infestations       
Lower respiratory tract infection  1  6/43 (13.95%)  7 6/46 (13.04%)  13 3/40 (7.50%)  6
Urinary tract infection  1  7/43 (16.28%)  14 3/46 (6.52%)  6 4/40 (10.00%)  6
Nasopharangytis  1  3/43 (6.98%)  4 5/46 (10.87%)  7 2/40 (5.00%)  5
Injury, poisoning and procedural complications       
Injury  1  3/43 (6.98%)  3 2/46 (4.35%)  3 3/40 (7.50%)  5
Fall  1  2/43 (4.65%)  2 5/46 (10.87%)  5 1/40 (2.50%)  1
Investigations       
Blood cholesterol increased  1  4/43 (9.30%)  4 5/46 (10.87%)  5 2/40 (5.00%)  2
Gamma-glutamyltransferase increased  1  3/43 (6.98%)  4 4/46 (8.70%)  5 2/40 (5.00%)  2
Blood alkaline phosphatase increased  1  3/43 (6.98%)  3 2/46 (4.35%)  3 2/40 (5.00%)  2
Blood creatinine increased  1  1/43 (2.33%)  1 4/46 (8.70%)  4 2/40 (5.00%)  3
Blood urea increased  1  1/43 (2.33%)  1 4/46 (8.70%)  4 2/40 (5.00%)  3
Alanine aminotransferase increased  1  4/43 (9.30%)  4 2/46 (4.35%)  2 0/40 (0.00%)  0
Aspartate aminotransferase increased  1  3/43 (6.98%)  3 2/46 (4.35%)  2 0/40 (0.00%)  0
Haematocrit decreased  1  0/43 (0.00%)  0 4/46 (8.70%)  4 1/40 (2.50%)  1
Haemoglobin decreased  1  1/43 (2.33%)  1 3/46 (6.52%)  4 1/40 (2.50%)  1
Red blood cell count decreased  1  0/43 (0.00%)  0 4/46 (8.70%)  5 1/40 (2.50%)  1
Cardiac murmur  1  0/43 (0.00%)  0 1/46 (2.17%)  1 2/40 (5.00%)  2
Weight increased  1  0/43 (0.00%)  0 0/46 (0.00%)  0 2/40 (5.00%)  2
Metabolism and nutrition disorders       
Diabetes mellitus  1  3/43 (6.98%)  3 1/46 (2.17%)  1 0/40 (0.00%)  0
Gout  1  1/43 (2.33%)  1 0/46 (0.00%)  0 2/40 (5.00%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/43 (4.65%)  4 5/46 (10.87%)  6 2/40 (5.00%)  2
Back pain  1  6/43 (13.95%)  6 5/46 (10.87%)  5 3/40 (7.50%)  5
Joint swelling  1  2/43 (4.65%)  2 1/46 (2.17%)  1 4/40 (10.00%)  4
Pain in extremity  1  3/43 (6.98%)  3 2/46 (4.35%)  3 2/40 (5.00%)  2
Nervous system disorders       
Dizziness  1  2/43 (4.65%)  2 4/46 (8.70%)  4 3/40 (7.50%)  5
Headache  1  6/43 (13.95%)  9 2/46 (4.35%)  2 3/40 (7.50%)  4
Lethargy  1  2/43 (4.65%)  2 3/46 (6.52%)  4 1/40 (2.50%)  1
Psychiatric disorders       
Confusional state  1  1/43 (2.33%)  2 3/46 (6.52%)  4 0/40 (0.00%)  0
Depression  1  0/43 (0.00%)  0 3/46 (6.52%)  4 1/40 (2.50%)  1
Insomnia  1  3/43 (6.98%)  3 3/46 (6.52%)  3 1/40 (2.50%)  1
Renal and urinary disorders       
Nocturia  1  4/43 (9.30%)  4 4/46 (8.70%)  4 1/40 (2.50%)  1
Dysuria  1  3/43 (6.98%)  5 2/46 (4.35%)  2 3/40 (7.50%)  5
Pollakiuria  1  2/43 (4.65%)  2 2/46 (4.35%)  2 2/40 (5.00%)  2
Urinary retention  1  0/43 (0.00%)  0 3/46 (6.52%)  3 0/40 (0.00%)  0
Reproductive system and breast disorders       
Testicular atrophy  1  3/43 (6.98%)  3 2/46 (4.35%)  2 5/40 (12.50%)  5
Respiratory, thoracic and mediastinal disorders       
Cough  1  4/43 (9.30%)  6 5/46 (10.87%)  5 3/40 (7.50%)  5
Dyspnoea  1  4/43 (9.30%)  4 1/46 (2.17%)  1 0/40 (0.00%)  0
Rhinorrhoea  1  3/43 (6.98%)  3 0/46 (0.00%)  0 0/40 (0.00%)  0
Pharyngolaryngeal pain  1  0/43 (0.00%)  0 0/46 (0.00%)  0 2/40 (5.00%)  2
Skin and subcutaneous tissue disorders       
Rash  1  2/43 (4.65%)  2 4/46 (8.70%)  5 2/40 (5.00%)  2
Eczema  1  3/43 (6.98%)  4 0/46 (0.00%)  0 0/40 (0.00%)  0
Hyperhidrosis  1  3/43 (6.98%)  3 3/46 (6.52%)  3 1/40 (2.50%)  1
Skin reaction  1  3/43 (6.98%)  3 0/46 (0.00%)  0 0/40 (0.00%)  0
Vascular disorders       
Hot flush  1  24/43 (55.81%)  25 25/46 (54.35%)  25 23/40 (57.50%)  27
Hypertension  1  5/43 (11.63%)  6 4/46 (8.70%)  5 4/40 (10.00%)  4
Flushing  1  4/43 (9.30%)  4 6/46 (13.04%)  6 2/40 (5.00%)  2
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
Name/Title: Ferring Pharmaceuticals
Organization: Clinical Development Support
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00245466     History of Changes
Other Study ID Numbers: FE200486 CS02A
First Submitted: October 26, 2005
First Posted: October 28, 2005
Results First Submitted: January 22, 2009
Results First Posted: June 11, 2009
Last Update Posted: May 20, 2011