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

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00245466
Collaborator
(none)
88
Enrollment
3
Arms
53
Duration (Months)

Study Details

Study Description

Brief Summary

To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.
Study Start Date :
Oct 1, 2001
Actual Primary Completion Date :
Mar 1, 2006
Actual Study Completion Date :
Mar 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Degarelix 80/80 + 40

In the main study (FE200486 CS02; NCT00819247) 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.

Drug: Degarelix
Given as a subcutaneous injection once every 4 weeks.
Other Names:
  • FE200486

    		•
    Experimental: Degarelix 40/40 + 40

    In the main study (FE200486 CS02; NCT00819247) 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.

    Drug: Degarelix
    Given as a subcutaneous injection once every 4 weeks.
    Other Names:
  • FE200486

    		•
    Experimental: Degarelix 80 + 20

    In the main study (FE200486 CS02; NCT00819247) 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.

    Drug: Degarelix
    Given as a subcutaneous injection once every 4 weeks.
    Other Names:
  • FE200486

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Liver Function Tests [3 years]

      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.

    2. Participants With Markedly Abnormal Change in Vital Signs and Body Weight [3 years]

      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.

    Secondary Outcome Measures

    1. Serum Levels of Testosterone After 1, 2, and 3 Years [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Has completed study treatment in study FE200486 CS02.

    • Has completed visit 16 in study FE200486 CS02.

    • Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ferring Pharmaceuticals

    Investigators

    • Study Director: Clinical Development Support, Ferring Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00245466
    Other Study ID Numbers:
    • FE200486 CS02A
    First Posted:
    Oct 28, 2005
    Last Update Posted:
    May 20, 2011
    Last Verified:
    May 1, 2011
    Keywords provided by , ,
    Prostate Cancer
    Androgen ablation therapy
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    Participant Flow

    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 Detail
    Arm/Group Title Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20
    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 2 3
    NOT COMPLETED 36 44 37

    Baseline Characteristics

    Arm/Group Title Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20 Total
    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 Participants 43 46 40 129
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    6
    14%
    5
    10.9%
    7
    17.5%
    18
    14%
    >=65 years
    37
    86%
    41
    89.1%
    33
    82.5%
    111
    86%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    72.4
    (6.60)
    73.7
    (7.22)
    71.8
    (7.08)
    72.7
    (6.97)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    43
    100%
    46
    100%
    40
    100%
    129
    100%
    Race/Ethnicity, Customized (participants) [Number]
    Black
    1
    2.3%
    3
    6.5%
    1
    2.5%
    5
    3.9%
    White
    42
    97.7%
    43
    93.5%
    37
    92.5%
    122
    94.6%
    Indian
    0
    0%
    0
    0%
    1
    2.5%
    1
    0.8%
    Afro-Carribean
    0
    0%
    0
    0%
    1
    2.5%
    1
    0.8%
    Gleason score (participants) [Number]
    Unknown
    1
    2.3%
    1
    2.2%
    1
    2.5%
    3
    2.3%
    2-4
    3
    7%
    4
    8.7%
    2
    5%
    9
    7%
    5-6
    11
    25.6%
    7
    15.2%
    11
    27.5%
    29
    22.5%
    7-10
    28
    65.1%
    34
    73.9%
    26
    65%
    88
    68.2%
    Number of Participants With Curative Intent (participants) [Number]
    Yes
    0
    0%
    2
    4.3%
    1
    2.5%
    3
    2.3%
    No
    43
    100%
    44
    95.7%
    39
    97.5%
    126
    97.7%
    Number of Participants at Each Stage of Prostate Cancer (participants) [Number]
    Localized
    8
    18.6%
    9
    19.6%
    5
    12.5%
    22
    17.1%
    Locally advanced
    21
    48.8%
    21
    45.7%
    18
    45%
    60
    46.5%
    Metastatic
    11
    25.6%
    14
    30.4%
    17
    42.5%
    42
    32.6%
    Not classifiable
    3
    7%
    2
    4.3%
    0
    0%
    5
    3.9%
    Body mass index (kilogram per square meter) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilogram per square meter]
    26.6
    (4.15)
    26.6
    (4.06)
    25.9
    (3.93)
    26.4
    (3.93)
    Serum testosterone levels (nanogram per milliliter) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [nanogram per milliliter]
    3.74
    4.11
    4.70
    3.98
    Weight (kilogram) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilogram]
    77.6
    (11.4)
    78.5
    (14.2)
    76.3
    (9.78)
    77.5
    (12.0)

    Outcome Measures

    1. Primary Outcome
    Title Liver Function Tests
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 43 46 40
    Abnormal alanine aminotransferase (ALAT)
    18
    41.9%
    16
    34.8%
    16
    40%
    Abnormal aspartate aminotransferase
    23
    53.5%
    22
    47.8%
    17
    42.5%
    Abnormal bilirubin
    3
    7%
    4
    8.7%
    5
    12.5%
    ALAT >3x ULN
    2
    4.7%
    2
    4.3%
    1
    2.5%
    ALAT >3x ULN, bilirubin >1.5x ULN
    0
    0%
    0
    0%
    1
    2.5%
    2. Primary Outcome
    Title Participants With Markedly Abnormal Change in Vital Signs and Body Weight
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 43 46 40
    Diastolic blood pressure <=50 and decrease >=15
    1
    2.3%
    0
    0%
    2
    5%
    Diastolic blood pressure >=105 and increase >=15
    0
    0%
    2
    4.3%
    0
    0%
    Systolic blood pressure <=90 and decrease >=20
    0
    0%
    0
    0%
    0
    0%
    Systolic blood pressure >=180 and increase >=20
    8
    18.6%
    7
    15.2%
    1
    2.5%
    Heart rate <=50 and decrease >=15
    0
    0%
    1
    2.2%
    2
    5%
    Heart rate >=120 and increase >=15
    0
    0%
    0
    0%
    0
    0%
    Body weight decrease of >=7 percent
    5
    11.6%
    4
    8.7%
    5
    12.5%
    Body weight increase of >=7 percent
    17
    39.5%
    14
    30.4%
    15
    37.5%
    3. Secondary Outcome
    Title Serum Levels of Testosterone After 1, 2, and 3 Years
    Description
    Time Frame 3 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20
    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.
    Measure Participants 43 46 40
    1 year (n=25,17,14)
    0.120
    0.086
    0.170
    2 years (n=16,9,8)
    0.143
    0.133
    0.305
    3 years (n=8,5,6)
    0.104
    0.132
    0.198

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Degarelix 80/80 + 40 Degarelix 40/40 + 40 Degarelix 80 + 20
    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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    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/ (NaN) 14/ (NaN) 10/ (NaN)
    Blood and lymphatic system disorders
    Anaemia 1/43 (2.3%) 1 1/46 (2.2%) 1 0/40 (0%) 0
    Cardiac disorders
    Cardio-respiratory arrest 1/43 (2.3%) 1 1/46 (2.2%) 1 0/40 (0%) 0
    Angina unstable 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Atrial fibrillation 0/43 (0%) 0 0/46 (0%) 0 1/40 (2.5%) 1
    Cardiac failure 1/43 (2.3%) 1 0/46 (0%) 0 0/40 (0%) 0
    Angina pectoris 1/43 (2.3%) 1 0/46 (0%) 0 1/40 (2.5%) 1
    Myocardial infarction 1/43 (2.3%) 1 1/46 (2.2%) 1 0/40 (0%) 0
    Cardiac failure congestive 1/43 (2.3%) 1 0/46 (0%) 0 0/40 (0%) 0
    Gastrointestinal disorders
    Abdominal discomfort 1/43 (2.3%) 1 0/46 (0%) 0 0/40 (0%) 0
    Constipation 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Diarrhoea 1/43 (2.3%) 1 0/46 (0%) 0 0/40 (0%) 0
    Dysphagia 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Nausea 0/43 (0%) 0 1/46 (2.2%) 2 0/40 (0%) 0
    Rectal haemorrhage 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Vomiting 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    General disorders
    Chest pain 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Asthenia 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Catheter related complication 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Condition aggravated 0/43 (0%) 0 0/46 (0%) 0 1/40 (2.5%) 1
    Hepatobiliary disorders
    Hepatic function abnormal 0/43 (0%) 0 0/46 (0%) 0 1/40 (2.5%) 1
    Immune system disorders
    Hypersensitivity 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Infections and infestations
    Bronchiectasis 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Cellulitis 1/43 (2.3%) 1 0/46 (0%) 0 0/40 (0%) 0
    Diverticulitis 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Gastroenteritis 1/43 (2.3%) 1 0/46 (0%) 0 0/40 (0%) 0
    Urinary tract infection 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Lobar pneumonia 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Sepsis 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Injury, poisoning and procedural complications
    Femoral neck fracture 1/43 (2.3%) 1 0/46 (0%) 0 1/40 (2.5%) 1
    Cardiac function disturbance postoperative 1/43 (2.3%) 1 0/46 (0%) 0 0/40 (0%) 0
    Lumbar vertebral fracture 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Pelvic fracture 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Subdural haematoma 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Post procedural haemorrhage 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Metabolism and nutrition disorders
    Hypercalcaemia 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Arthraligia 0/43 (0%) 0 0/46 (0%) 0 1/40 (2.5%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 0/43 (0%) 0 0/46 (0%) 0 1/40 (2.5%) 1
    Metastatic neoplasm 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Lung neoplasm malignant 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Nervous system disorders
    Cerebrovascular accident 2/43 (4.7%) 2 0/46 (0%) 0 1/40 (2.5%) 1
    Grand mal convulsion 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Hemiparesis 1/43 (2.3%) 1 0/46 (0%) 0 0/40 (0%) 0
    Lethargy 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Parkinson's disease 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Syncope vasovagal 0/43 (0%) 0 1/46 (2.2%) 2 0/40 (0%) 0
    Cerebral haemorrhage 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Syncope 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Psychiatric disorders
    Confusional state 1/43 (2.3%) 2 1/46 (2.2%) 1 0/40 (0%) 0
    Depression 1/43 (2.3%) 1 0/46 (0%) 0 1/40 (2.5%) 1
    Alcoholism 1/43 (2.3%) 1 0/46 (0%) 0 0/40 (0%) 0
    Renal and urinary disorders
    Urinary retention 1/43 (2.3%) 1 0/46 (0%) 0 1/40 (2.5%) 1
    Bladder obstruction 0/43 (0%) 0 0/46 (0%) 0 1/40 (2.5%) 1
    Calculus bladder 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Dysuria 0/43 (0%) 0 0/46 (0%) 0 1/40 (2.5%) 1
    Urine flow decreased 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/43 (0%) 0 3/46 (6.5%) 5 0/40 (0%) 0
    Alveolitis fibrosing 1/43 (2.3%) 1 0/46 (0%) 0 0/40 (0%) 0
    Dyspnoea exertional 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Pulmonary embolism 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Social circumstances
    Convalescent 0/43 (0%) 0 1/46 (2.2%) 1 0/40 (0%) 0
    Surgical and medical procedures
    Suprapubic catheter insertion 1/43 (2.3%) 1 0/46 (0%) 0 0/40 (0%) 0
    Other (Not Including 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 42/ (NaN) 40/ (NaN) 35/ (NaN)
    Blood and lymphatic system disorders
    Anaemia 2/43 (4.7%) 2 3/46 (6.5%) 3 2/40 (5%) 2
    Cardiac disorders
    Atrial fibrillation 0/43 (0%) 0 3/46 (6.5%) 3 1/40 (2.5%) 1
    Gastrointestinal disorders
    Constipation 5/43 (11.6%) 5 5/46 (10.9%) 6 3/40 (7.5%) 3
    Diarrhoea 9/43 (20.9%) 17 3/46 (6.5%) 3 3/40 (7.5%) 6
    Dyspepsia 1/43 (2.3%) 4 3/46 (6.5%) 3 3/40 (7.5%) 3
    Abdominal distension 0/43 (0%) 0 3/46 (6.5%) 3 0/40 (0%) 0
    Nausea 4/43 (9.3%) 5 5/46 (10.9%) 6 1/40 (2.5%) 1
    Inguinal hernia 2/43 (4.7%) 2 1/46 (2.2%) 1 2/40 (5%) 3
    Abdominal pain 1/43 (2.3%) 1 0/46 (0%) 0 3/40 (7.5%) 3
    General disorders
    Oedema peripheral 4/43 (9.3%) 4 7/46 (15.2%) 9 1/40 (2.5%) 2
    Influenza like illness 3/43 (7%) 8 2/46 (4.3%) 2 2/40 (5%) 2
    Malaise 3/43 (7%) 4 0/46 (0%) 0 0/40 (0%) 0
    Fatigue 2/43 (4.7%) 3 4/46 (8.7%) 5 0/40 (0%) 0
    Pyrexia 3/43 (7%) 4 1/46 (2.2%) 1 0/40 (0%) 0
    Suprapubic pain 0/43 (0%) 0 0/46 (0%) 0 2/40 (5%) 2
    Infections and infestations
    Lower respiratory tract infection 6/43 (14%) 7 6/46 (13%) 13 3/40 (7.5%) 6
    Urinary tract infection 7/43 (16.3%) 14 3/46 (6.5%) 6 4/40 (10%) 6
    Nasopharangytis 3/43 (7%) 4 5/46 (10.9%) 7 2/40 (5%) 5
    Injury, poisoning and procedural complications
    Injury 3/43 (7%) 3 2/46 (4.3%) 3 3/40 (7.5%) 5
    Fall 2/43 (4.7%) 2 5/46 (10.9%) 5 1/40 (2.5%) 1
    Investigations
    Blood cholesterol increased 4/43 (9.3%) 4 5/46 (10.9%) 5 2/40 (5%) 2
    Gamma-glutamyltransferase increased 3/43 (7%) 4 4/46 (8.7%) 5 2/40 (5%) 2
    Blood alkaline phosphatase increased 3/43 (7%) 3 2/46 (4.3%) 3 2/40 (5%) 2
    Blood creatinine increased 1/43 (2.3%) 1 4/46 (8.7%) 4 2/40 (5%) 3
    Blood urea increased 1/43 (2.3%) 1 4/46 (8.7%) 4 2/40 (5%) 3
    Alanine aminotransferase increased 4/43 (9.3%) 4 2/46 (4.3%) 2 0/40 (0%) 0
    Aspartate aminotransferase increased 3/43 (7%) 3 2/46 (4.3%) 2 0/40 (0%) 0
    Haematocrit decreased 0/43 (0%) 0 4/46 (8.7%) 4 1/40 (2.5%) 1
    Haemoglobin decreased 1/43 (2.3%) 1 3/46 (6.5%) 4 1/40 (2.5%) 1
    Red blood cell count decreased 0/43 (0%) 0 4/46 (8.7%) 5 1/40 (2.5%) 1
    Cardiac murmur 0/43 (0%) 0 1/46 (2.2%) 1 2/40 (5%) 2
    Weight increased 0/43 (0%) 0 0/46 (0%) 0 2/40 (5%) 2
    Metabolism and nutrition disorders
    Diabetes mellitus 3/43 (7%) 3 1/46 (2.2%) 1 0/40 (0%) 0
    Gout 1/43 (2.3%) 1 0/46 (0%) 0 2/40 (5%) 2
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/43 (4.7%) 4 5/46 (10.9%) 6 2/40 (5%) 2
    Back pain 6/43 (14%) 6 5/46 (10.9%) 5 3/40 (7.5%) 5
    Joint swelling 2/43 (4.7%) 2 1/46 (2.2%) 1 4/40 (10%) 4
    Pain in extremity 3/43 (7%) 3 2/46 (4.3%) 3 2/40 (5%) 2
    Nervous system disorders
    Dizziness 2/43 (4.7%) 2 4/46 (8.7%) 4 3/40 (7.5%) 5
    Headache 6/43 (14%) 9 2/46 (4.3%) 2 3/40 (7.5%) 4
    Lethargy 2/43 (4.7%) 2 3/46 (6.5%) 4 1/40 (2.5%) 1
    Psychiatric disorders
    Confusional state 1/43 (2.3%) 2 3/46 (6.5%) 4 0/40 (0%) 0
    Depression 0/43 (0%) 0 3/46 (6.5%) 4 1/40 (2.5%) 1
    Insomnia 3/43 (7%) 3 3/46 (6.5%) 3 1/40 (2.5%) 1
    Renal and urinary disorders
    Nocturia 4/43 (9.3%) 4 4/46 (8.7%) 4 1/40 (2.5%) 1
    Dysuria 3/43 (7%) 5 2/46 (4.3%) 2 3/40 (7.5%) 5
    Pollakiuria 2/43 (4.7%) 2 2/46 (4.3%) 2 2/40 (5%) 2
    Urinary retention 0/43 (0%) 0 3/46 (6.5%) 3 0/40 (0%) 0
    Reproductive system and breast disorders
    Testicular atrophy 3/43 (7%) 3 2/46 (4.3%) 2 5/40 (12.5%) 5
    Respiratory, thoracic and mediastinal disorders
    Cough 4/43 (9.3%) 6 5/46 (10.9%) 5 3/40 (7.5%) 5
    Dyspnoea 4/43 (9.3%) 4 1/46 (2.2%) 1 0/40 (0%) 0
    Rhinorrhoea 3/43 (7%) 3 0/46 (0%) 0 0/40 (0%) 0
    Pharyngolaryngeal pain 0/43 (0%) 0 0/46 (0%) 0 2/40 (5%) 2
    Skin and subcutaneous tissue disorders
    Rash 2/43 (4.7%) 2 4/46 (8.7%) 5 2/40 (5%) 2
    Eczema 3/43 (7%) 4 0/46 (0%) 0 0/40 (0%) 0
    Hyperhidrosis 3/43 (7%) 3 3/46 (6.5%) 3 1/40 (2.5%) 1
    Skin reaction 3/43 (7%) 3 0/46 (0%) 0 0/40 (0%) 0
    Vascular disorders
    Hot flush 24/43 (55.8%) 25 25/46 (54.3%) 25 23/40 (57.5%) 27
    Hypertension 5/43 (11.6%) 6 4/46 (8.7%) 5 4/40 (10%) 4
    Flushing 4/43 (9.3%) 4 6/46 (13%) 6 2/40 (5%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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
    Phone
    Email DK0-Disclosure@ferring.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00245466
    Other Study ID Numbers:
    • FE200486 CS02A
    First Posted:
    Oct 28, 2005
    Last Update Posted:
    May 20, 2011
    Last Verified:
    May 1, 2011