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Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00215657
Collaborator
(none)
131
Enrollment
8
Arms
36
Duration (Months)

Study Details

Study Description

Brief Summary

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in 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 CS07; NCT00818623) and the extension study FE200486 CS07A.

Study Design

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Study Start Date :
Mar 1, 2003
Actual Primary Completion Date :
Mar 1, 2006
Actual Study Completion Date :
Mar 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Degarelix 120 mg (20 mg/mL)

Degarelix 120 mg (20 mg/mL)

Drug: Degarelix
Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
  • FE200486

    		•
    Experimental: Degarelix 120 mg (40 mg/mL)

    Degarelix 120 mg (40 mg/mL)

    Drug: Degarelix
    Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Other Names:
  • FE200486

    		•
    Experimental: Degarelix 160 mg (40 mg/mL)

    Degarelix 160 mg (40 mg/mL)

    Drug: Degarelix
    Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Other Names:
  • FE200486

    		•
    Experimental: Degarelix 200 mg (40 mg/mL)

    Degarelix 200 mg (40 mg/mL)

    Drug: Degarelix
    Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Other Names:
  • FE200486

    		•
    Experimental: Degarelix 200 mg (60 mg/mL)

    Degarelix 200 mg (60 mg/mL)

    Drug: Degarelix
    Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Other Names:
  • FE200486

    		•
    Experimental: Degarelix 240 mg (40 mg/mL)

    Degarelix 240 mg (40 mg/mL)

    Drug: Degarelix
    Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Other Names:
  • FE200486

    		•
    Experimental: Degarelix 240 mg (60 mg/mL)

    Degarelix 240 mg (60 mg/mL)

    Drug: Degarelix
    Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Other Names:
  • FE200486

    		•
    Experimental: Degarelix 320 mg (60 mg/mL)

    Degarelix 320 mg (60 mg/mL)

    Drug: Degarelix
    Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    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.

    Eligibility Criteria

    Criteria

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

    • Males aged 18 or over

    • Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)

    • Has completed Study FE200486 CS07

    • Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07

    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:
    NCT00215657
    Other Study ID Numbers:
    • FE200486 CS07A
    First Posted:
    Sep 22, 2005
    Last Update Posted:
    May 20, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    Participant Flow

    Recruitment Details Participants who responded to degarelix in FE200486 CS07 (NCT00818623) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS07.
    Pre-assignment Detail 180 participants started the main study CS07 and 172 participants received degarelix treatment (intention-to-treat population). Of these, 131 participants were recruited into the extension study CS07A
    Arm/Group Title Degarelix 120mg (20mg/mL) Degarelix 120mg (40mg/mL) Degarelix 160mg (40mg/mL) Degarelix 200mg (40mg/mL) Degarelix 200mg (60mg/mL) Degarelix 240mg (40mg/mL) Degarelix 240mg (60mg/mL) Degarelix 320mg (60mg/mL)
    Arm/Group Description Degarelix 120 mg (20 mg/mL) Degarelix 120 mg (40 mg/mL) Degarelix 160 mg (40 mg/mL) Degarelix 200 mg (40 mg/mL) Degarelix 200 mg (60 mg/mL) Degarelix 240 mg (40 mg/mL) Degarelix 240 mg (60 mg/mL) Degarelix 320 mg (60 mg/mL)
    Period Title: Overall Study
    STARTED 26 12 13 24 27 24 27 27
    Intention-to-treat Population 25 12 12 24 24 24 24 27
    Started FE200486 CS07A 20 6 7 24 17 20 14 23
    COMPLETED 4 1 2 6 4 4 4 11
    NOT COMPLETED 22 11 11 18 23 20 23 16

    Baseline Characteristics

    Arm/Group Title Degarelix 120mg (20mg/mL) Degarelix 120mg (40mg/mL) Degarelix 160mg (40mg/mL) Degarelix 200mg (40mg/mL) Degarelix 200mg (60mg/mL) Degarelix 240mg (40mg/mL) Degarelix 240mg (60mg/mL) Degarelix 320mg (60mg/mL) Total
    Arm/Group Description Degarelix 120 mg (20 mg/mL) Degarelix 120 mg (40 mg/mL) Degarelix 160 mg (40 mg/mL) Degarelix 200 mg (40 mg/mL) Degarelix 200 mg (60 mg/mL) Degarelix 240 mg (40 mg/mL) Degarelix 240 mg (60 mg/mL) Degarelix 320 mg (60 mg/mL) Total of all reporting groups
    Overall Participants 25 12 12 24 24 24 24 27 172
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    7
    28%
    0
    0%
    2
    16.7%
    2
    8.3%
    4
    16.7%
    2
    8.3%
    6
    25%
    6
    22.2%
    29
    16.9%
    >=65 years
    18
    72%
    12
    100%
    10
    83.3%
    22
    91.7%
    20
    83.3%
    22
    91.7%
    18
    75%
    21
    77.8%
    143
    83.1%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    70.0
    (10.3)
    73.8
    (3.97)
    70.1
    (8.08)
    74.3
    (6.48)
    71.5
    (8.27)
    73.1
    (5.96)
    71.7
    (9.54)
    71.1
    (6.87)
    71.9
    (7.83)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    25
    100%
    12
    100%
    12
    100%
    24
    100%
    24
    100%
    24
    100%
    24
    100%
    27
    100%
    172
    100%
    Race/Ethnicity, Customized (participants) [Number]
    Caucasian
    25
    100%
    12
    100%
    12
    100%
    24
    100%
    24
    100%
    24
    100%
    24
    100%
    27
    100%
    172
    100%
    Curative intent (participants) [Number]
    Yes
    0
    0%
    0
    0%
    2
    16.7%
    3
    12.5%
    1
    4.2%
    0
    0%
    0
    0%
    1
    3.7%
    7
    4.1%
    No
    25
    100%
    12
    100%
    10
    83.3%
    21
    87.5%
    23
    95.8%
    24
    100%
    24
    100%
    26
    96.3%
    165
    95.9%
    Gleason score (participants) [Number]
    2-4
    4
    16%
    0
    0%
    2
    16.7%
    1
    4.2%
    5
    20.8%
    2
    8.3%
    5
    20.8%
    12
    44.4%
    31
    18%
    5-6
    4
    16%
    7
    58.3%
    5
    41.7%
    6
    25%
    3
    12.5%
    6
    25%
    6
    25%
    6
    22.2%
    43
    25%
    7-10
    17
    68%
    5
    41.7%
    5
    41.7%
    17
    70.8%
    16
    66.7%
    16
    66.7%
    13
    54.2%
    9
    33.3%
    98
    57%
    Stage of prostate cancer (participants) [Number]
    Localized
    10
    40%
    1
    8.3%
    3
    25%
    3
    12.5%
    1
    4.2%
    6
    25%
    8
    33.3%
    14
    51.9%
    46
    26.7%
    Locally advanced
    6
    24%
    6
    50%
    5
    41.7%
    14
    58.3%
    8
    33.3%
    10
    41.7%
    5
    20.8%
    9
    33.3%
    63
    36.6%
    Metastatic
    9
    36%
    3
    25%
    4
    33.3%
    6
    25%
    12
    50%
    6
    25%
    10
    41.7%
    2
    7.4%
    52
    30.2%
    Not classifiable
    0
    0%
    2
    16.7%
    0
    0%
    1
    4.2%
    3
    12.5%
    2
    8.3%
    1
    4.2%
    2
    7.4%
    11
    6.4%
    Body mass index (kilogram per square meter) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilogram per square meter]
    26.2
    (2.97)
    26.6
    (4.58)
    26.3
    (3.74)
    25.9
    (2.99)
    24.5
    (2.92)
    26.9
    (3.18)
    24.8
    (2.72)
    27.1
    (3.63)
    26.0
    (3.32)
    Time since prostate cancer diagnosis (days) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [days]
    83
    (157)
    66
    (53)
    222
    (328)
    146
    (298)
    252
    (560)
    303
    (837)
    121
    (425)
    47
    (54)
    156
    (439)
    Weight (kilogram) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilogram]
    77.8
    (12.4)
    82.2
    (12.1)
    80.7
    (11.8)
    78.2
    (13.7)
    74.2
    (9.88)
    81.5
    (10.7)
    73.5
    (9.55)
    81.7
    (11.1)
    78.4
    (11.6)

    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 CS07) and the extension study FE200486 CS07A
    Arm/Group Title Degarelix 120mg (20mg/mL) Degarelix 120mg (40mg/mL) Degarelix 160mg (40mg/mL) Degarelix 200mg (40mg/mL) Degarelix 200mg (60mg/mL) Degarelix 240mg (40mg/mL) Degarelix 240mg (60mg/mL) Degarelix 320mg (60mg/mL)
    Arm/Group Description Degarelix 120 mg (20 mg/mL) Degarelix 120 mg (40 mg/mL) Degarelix 160 mg (40 mg/mL) Degarelix 200 mg (40 mg/mL) Degarelix 200 mg (60 mg/mL) Degarelix 240 mg (40 mg/mL) Degarelix 240 mg (60 mg/mL) Degarelix 320 mg (60 mg/mL)
    Measure Participants 25 12 12 24 24 24 24 27
    Abnormal alanine aminotransferase (ALAT)
    11
    44%
    4
    33.3%
    3
    25%
    7
    29.2%
    7
    29.2%
    7
    29.2%
    7
    29.2%
    9
    33.3%
    Abnormal aspartate aminotransferase
    9
    36%
    4
    33.3%
    2
    16.7%
    6
    25%
    8
    33.3%
    6
    25%
    6
    25%
    7
    25.9%
    Abnormal bilirubin
    4
    16%
    2
    16.7%
    0
    0%
    2
    8.3%
    0
    0%
    2
    8.3%
    0
    0%
    1
    3.7%
    ALAT >3x ULN
    4
    16%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    8.3%
    1
    4.2%
    1
    3.7%
    ALAT >3x ULN, bilirubin >2x ULN
    1
    4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    4.2%
    0
    0%
    0
    0%
    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 CS07) and the extension study (FE200486 CS07A).
    Arm/Group Title Degarelix 120mg (20mg/mL) Degarelix 120mg (40mg/mL) Degarelix 160mg (40mg/mL) Degarelix 200mg (40mg/mL) Degarelix 200mg (60mg/mL) Degarelix 240mg (40mg/mL) Degarelix 240mg (60mg/mL) Degarelix 320mg (60mg/mL)
    Arm/Group Description Degarelix 120 mg (20 mg/mL) Degarelix 120 mg (40 mg/mL) Degarelix 160 mg (40 mg/mL) Degarelix 200 mg (40 mg/mL) Degarelix 200 mg (60 mg/mL) Degarelix 240 mg (40 mg/mL) Degarelix 240 mg (60 mg/mL) Degarelix 320 mg (60 mg/mL)
    Measure Participants 25 12 12 24 24 24 24 27
    Diastolic blood pressure <=50 and decrease >=15
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    4.2%
    0
    0%
    1
    4.2%
    0
    0%
    Diastolic blood pressure >=105 and increase >=15
    2
    8%
    0
    0%
    1
    8.3%
    1
    4.2%
    2
    8.3%
    1
    4.2%
    1
    4.2%
    2
    7.4%
    Systolic blood pressure <=90 and decrease >=20
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Systolic blood pressure >=180 and increase >=20
    0
    0%
    0
    0%
    2
    16.7%
    5
    20.8%
    2
    8.3%
    6
    25%
    2
    8.3%
    3
    11.1%
    Heart rate <=50 and decrease >=15
    1
    4%
    1
    8.3%
    2
    16.7%
    0
    0%
    2
    8.3%
    1
    4.2%
    1
    4.2%
    1
    3.7%
    Heart rate >=120 and increase >=15
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.7%
    Body weight decrease of >=7 percent
    1
    4%
    0
    0%
    1
    8.3%
    1
    4.2%
    0
    0%
    1
    4.2%
    1
    4.2%
    1
    3.7%
    Body weight increase of >=7 percent
    4
    16%
    2
    16.7%
    3
    25%
    9
    37.5%
    3
    12.5%
    8
    33.3%
    7
    29.2%
    2
    7.4%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Degarelix 120mg (20mg/mL) Degarelix 120mg (40mg/mL) Degarelix 160mg (40mg/mL) Degarelix 200mg (40mg/mL) Degarelix 200mg (60mg/mL) Degarelix 240mg (40mg/mL) Degarelix 240mg (60mg/mL) Degarelix 320mg (60mg/mL)
    Arm/Group Description Degarelix 120 mg (20 mg/mL) Degarelix 120 mg (40 mg/mL) Degarelix 160 mg (40 mg/mL) Degarelix 200 mg (40 mg/mL) Degarelix 200 mg (60 mg/mL) Degarelix 240 mg (40 mg/mL) Degarelix 240 mg (60 mg/mL) Degarelix 320 mg (60 mg/mL)
    All Cause Mortality
    Degarelix 120mg (20mg/mL) Degarelix 120mg (40mg/mL) Degarelix 160mg (40mg/mL) Degarelix 200mg (40mg/mL) Degarelix 200mg (60mg/mL) Degarelix 240mg (40mg/mL) Degarelix 240mg (60mg/mL) Degarelix 320mg (60mg/mL)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Degarelix 120mg (20mg/mL) Degarelix 120mg (40mg/mL) Degarelix 160mg (40mg/mL) Degarelix 200mg (40mg/mL) Degarelix 200mg (60mg/mL) Degarelix 240mg (40mg/mL) Degarelix 240mg (60mg/mL) Degarelix 320mg (60mg/mL)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/ (NaN) 4/ (NaN) 3/ (NaN) 7/ (NaN) 8/ (NaN) 5/ (NaN) 3/ (NaN) 9/ (NaN)
    Blood and lymphatic system disorders
    Hypochromic anaemia 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Cardiac disorders
    Cardiac failure 1/25 (4%) 2 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Angina unstable 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Myocardial infarction 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Myocardial ischemia 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Acute myocardial infarction 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    Angina pectoris 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Ear and labyrinth disorders
    Vertigo 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Gastrointestinal disorders
    Inguinal hernia 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Gastritis 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Mallory-weiss syndrome 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Mechanical ileus 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Vomiting 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    General disorders
    Disease progression 1/25 (4%) 1 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Pyrexia 1/25 (4%) 1 0/12 (0%) 0 1/12 (8.3%) 1 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Asthenia 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Chest pain 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Condition aggravated 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Oedema 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Hepatobiliary disorders
    Cholecystitis acute 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Cholelithiasis 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    Hepatitis toxic 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Infections and infestations
    Sepsis 1/25 (4%) 1 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Urinary tract infection 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Bronchitis 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Erysipelas 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Infection 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Neutropenic sepsis 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Pneumonia 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Gangrene 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Injury, poisoning and procedural complications
    Caustic injury 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Contusion 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Subdural haematoma 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Humerus fracture 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Investigations
    Gamma-glutamyltransferase increased 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 2
    Musculoskeletal and connective tissue disorders
    Back pain 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Arthralgia 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Osteoarthritis 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Osteonecrosis 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Intervertebral disc protrusion 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lung 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Abdominal neoplasm 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Basal cell carcinoma 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Bladder cancer 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Bladder transitional cell carcinoma stage iii 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Bronchial carcinoma 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Colon cancer 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Laryngeal cancer 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Metastases to liver 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Metastasis 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Metastatic neoplasm 2/25 (8%) 2 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Metastatic pain 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Neoplasm progression 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Prostate cancer metastatic 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Metastases to bone 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    Pancreatic carcinoma 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Prostate cancer 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Nervous system disorders
    Cerebral infarction 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Epilepsy 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Parkinson's disease 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Spinal cord compression 1/25 (4%) 1 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Areflexia 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Ischaemic stroke 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Paraplegia 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Psychiatric disorders
    Completed suicide 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Depression 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Renal and urinary disorders
    Renal failure acute 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Urinary retention 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Haematuria 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    Hydronephrosis 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Haemoptysis 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Aspiration 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    Chronic obstructive pulmonary disease 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Surgical and medical procedures
    Amputation revision 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Vascular disorders
    Thrombosis 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Deep vein thrombosis 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Hypertension 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    Other (Not Including Serious) Adverse Events
    Degarelix 120mg (20mg/mL) Degarelix 120mg (40mg/mL) Degarelix 160mg (40mg/mL) Degarelix 200mg (40mg/mL) Degarelix 200mg (60mg/mL) Degarelix 240mg (40mg/mL) Degarelix 240mg (60mg/mL) Degarelix 320mg (60mg/mL)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 18/ (NaN) 10/ (NaN) 9/ (NaN) 24/ (NaN) 17/ (NaN) 22/ (NaN) 12/ (NaN) 19/ (NaN)
    Blood and lymphatic system disorders
    Anaemia 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Cardiac disorders
    Angina pectoris 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 1/24 (4.2%) 1 1/24 (4.2%) 1 2/27 (7.4%) 2
    Arrhytmia 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Atrial fibrillation 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    Bradycardia 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Congenital, familial and genetic disorders
    Phimosis 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Ear and labyrinth disorders
    Vertigo 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    Eye disorders
    Cataract 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 2/24 (8.3%) 2 1/27 (3.7%) 1
    Glaucoma 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Gastrointestinal disorders
    Constipation 2/25 (8%) 2 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 1/27 (3.7%) 1
    Nausea 0/25 (0%) 0 2/12 (16.7%) 2 1/12 (8.3%) 1 3/24 (12.5%) 4 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    Abdominal pain 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Diarrhoea 1/25 (4%) 1 1/12 (8.3%) 1 0/12 (0%) 0 4/24 (16.7%) 4 0/24 (0%) 0 1/24 (4.2%) 1 1/24 (4.2%) 1 1/27 (3.7%) 1
    Vomiting 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 1/24 (4.2%) 2 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Abdominal pain lower 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 0/27 (0%) 0
    Abdominal pain upper 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Dyspepsia 1/25 (4%) 1 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Gastritis 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Haemorrhoids 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Inguinal hernia 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Anal fissure 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Rectal haemorrhage 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Stomach discomfort 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    General disorders
    Pyrexia 2/25 (8%) 2 0/12 (0%) 0 1/12 (8.3%) 2 2/24 (8.3%) 3 0/24 (0%) 0 2/24 (8.3%) 4 1/24 (4.2%) 2 1/27 (3.7%) 1
    Fatigue 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 5/24 (20.8%) 7 2/24 (8.3%) 2 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Injection site erythema 0/25 (0%) 0 1/12 (8.3%) 1 1/12 (8.3%) 2 4/24 (16.7%) 4 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Injection site induration 1/25 (4%) 1 0/12 (0%) 0 1/12 (8.3%) 1 2/24 (8.3%) 2 0/24 (0%) 0 1/24 (4.2%) 2 0/24 (0%) 0 0/27 (0%) 0
    Injection site swelling 1/25 (4%) 1 0/12 (0%) 0 1/12 (8.3%) 2 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Injection site pain 1/25 (4%) 1 2/12 (16.7%) 2 1/12 (8.3%) 1 2/24 (8.3%) 2 2/24 (8.3%) 2 2/24 (8.3%) 2 0/24 (0%) 0 0/27 (0%) 0
    Oedema peripheral 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 1/24 (4.2%) 1 2/24 (8.3%) 3 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Chills 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 0/27 (0%) 0
    Feeling of body temperature change 2/25 (8%) 3 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Injection site pruritus 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Injection site reaction 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Chest pain 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 0/27 (0%) 0
    Infections and infestations
    Urinary tract infection 3/25 (12%) 4 0/12 (0%) 0 1/12 (8.3%) 1 4/24 (16.7%) 6 2/24 (8.3%) 2 4/24 (16.7%) 5 4/24 (16.7%) 5 2/27 (7.4%) 2
    Nasopharyngitis 1/25 (4%) 1 3/12 (25%) 3 0/12 (0%) 0 4/24 (16.7%) 4 0/24 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 1/27 (3.7%) 1
    Influenza 1/25 (4%) 1 1/12 (8.3%) 1 0/12 (0%) 0 1/24 (4.2%) 2 0/24 (0%) 0 1/24 (4.2%) 1 1/24 (4.2%) 1 0/27 (0%) 0
    Injection site abscess 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 2/27 (7.4%) 2
    Localised infection 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Nail infection 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Oral fungal infection 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Sinusitis 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Cystitis 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Injury, poisoning and procedural complications
    Injury 0/25 (0%) 0 1/12 (8.3%) 4 1/12 (8.3%) 1 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Investigations
    Blood alkaline phosphatase increased 4/25 (16%) 5 1/12 (8.3%) 2 0/12 (0%) 0 2/24 (8.3%) 3 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Alanine aminotranseferases increased 4/25 (16%) 5 1/12 (8.3%) 3 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Gamma-glutamyltransferase increased 3/25 (12%) 4 1/12 (8.3%) 3 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 3 0/24 (0%) 0 1/27 (3.7%) 1
    Weight decreased 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 2/24 (8.3%) 2 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Aspartate aminotransferase increased 3/25 (12%) 3 1/12 (8.3%) 3 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Blood creatinine increased 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Hepatic enzyme increased 1/25 (4%) 1 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 0/27 (0%) 0
    White blood cells urine positive 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Blood pressure increased 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 2/27 (7.4%) 3
    Lymphocyte count decreased 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Prostatic specific antigen increased 1/25 (4%) 1 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Metabolism and nutrition disorders
    Hypercholesterolaemia 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Musculoskeletal and connective tissue disorders
    Back pain 1/25 (4%) 1 1/12 (8.3%) 2 0/12 (0%) 0 5/24 (20.8%) 5 3/24 (12.5%) 4 3/24 (12.5%) 5 2/24 (8.3%) 2 1/27 (3.7%) 3
    Arthralgia 2/25 (8%) 2 0/12 (0%) 0 2/12 (16.7%) 2 2/24 (8.3%) 2 2/24 (8.3%) 2 1/24 (4.2%) 4 1/24 (4.2%) 1 2/27 (7.4%) 2
    Musculoskeletal pain 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 2 3/24 (12.5%) 3 1/24 (4.2%) 1 1/24 (4.2%) 1 1/27 (3.7%) 1
    Osteoarthritis 1/25 (4%) 1 0/12 (0%) 0 0/12 (0%) 0 2/24 (8.3%) 2 0/24 (0%) 0 1/24 (4.2%) 1 1/24 (4.2%) 1 0/27 (0%) 0
    Bone pain 2/25 (8%) 3 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Arthritis reactive 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Myalgia 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 1/24 (4.2%) 1 0/27 (0%) 0
    Muscular weakness 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Neck pain 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic pain 2/25 (8%) 2 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Nervous system disorders
    Dizziness 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 3/24 (12.5%) 3 0/24 (0%) 0 0/24 (0%) 0 3/24 (12.5%) 3 0/27 (0%) 0
    Headache 1/25 (4%) 1 2/12 (16.7%) 2 0/12 (0%) 0 4/24 (16.7%) 6 0/24 (0%) 0 3/24 (12.5%) 3 0/24 (0%) 0 0/27 (0%) 0
    Anosmia 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Hypoaesthesia 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Psychiatric disorders
    Insomnia 3/25 (12%) 3 0/12 (0%) 0 1/12 (8.3%) 1 4/24 (16.7%) 4 1/24 (4.2%) 1 0/24 (0%) 0 1/24 (4.2%) 2 0/27 (0%) 0
    Nervousness 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Nightmare 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Renal and urinary disorders
    Haematuria 0/25 (0%) 0 0/12 (0%) 0 2/12 (16.7%) 3 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Pollakiuria 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 1/24 (4.2%) 2 1/24 (4.2%) 1 2/24 (8.3%) 2 1/24 (4.2%) 1 0/27 (0%) 0
    Cystitis noninfective 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Nocturia 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 3/24 (12.5%) 3 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Reproductive system and breast disorders
    Erectile dysfunction 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    Prostatitis 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Cough 2/25 (8%) 2 2/12 (16.7%) 2 0/12 (0%) 0 1/24 (4.2%) 1 2/24 (8.3%) 2 0/24 (0%) 0 2/24 (8.3%) 2 0/27 (0%) 0
    Epistaxis 2/25 (8%) 2 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Pharyngolaryngeal pain 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Nasal congestion 1/25 (4%) 1 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis 6/25 (24%) 6 2/12 (16.7%) 2 1/12 (8.3%) 1 5/24 (20.8%) 6 5/24 (20.8%) 5 5/24 (20.8%) 5 2/24 (8.3%) 2 3/27 (11.1%) 3
    Erythema 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 2 1/24 (4.2%) 2 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/27 (0%) 0
    Rash pruritic 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Skin reaction 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 2 0/27 (0%) 0
    Eczema 0/25 (0%) 0 1/12 (8.3%) 2 0/12 (0%) 0 1/24 (4.2%) 1 1/24 (4.2%) 1 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Vascular disorders
    Hot flush 4/25 (16%) 4 1/12 (8.3%) 1 3/12 (25%) 4 12/24 (50%) 14 6/24 (25%) 6 9/24 (37.5%) 9 4/24 (16.7%) 5 12/27 (44.4%) 13
    Hypertension 0/25 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 2/24 (8.3%) 2 1/24 (4.2%) 1 0/27 (0%) 0
    Flushing 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0

    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:
    NCT00215657
    Other Study ID Numbers:
    • FE200486 CS07A
    First Posted:
    Sep 22, 2005
    Last Update Posted:
    May 20, 2011
    Last Verified:
    May 1, 2011