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Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00818623
Collaborator
(none)
172
Enrollment
30
Locations
8
Arms
23
Duration (Months)
5.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
172 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients
Study Start Date :
Nov 1, 2002
Actual Primary Completion Date :
Oct 1, 2004
Actual Study Completion Date :
Oct 1, 2004

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)) was given as a subcutaneous injection
Other Names:
  • FE200486

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

    Degarelix 120 mg (40 mg/mL)

    Drug: Degarelix
    Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection
    Other Names:
  • FE200486

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

    Degarelix 160 mg (40 mg/mL)

    Drug: Degarelix
    Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection
    Other Names:
  • FE200486

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

    Degarelix 200 mg (40 mg/mL)

    Drug: Degarelix
    Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection
    Other Names:
  • FE200486

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

    Degarelix 200 mg (60 mg/mL)

    Drug: Degarelix
    Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection
    Other Names:
  • FE200486

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

    Degarelix 240 mg (40 mg/mL)

    Drug: Degarelix
    Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection
    Other Names:
  • FE200486

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

    Degarelix 240 mg (60 mg/mL)

    Drug: Degarelix
    Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection
    Other Names:
  • FE200486

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

    Degarelix 320 mg (60 mg/mL)

    Drug: Degarelix
    Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection
    Other Names:
  • FE200486

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time From Dosing Until Testosterone Levels >0.5 ng/mL [3 months]

      Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.

    Secondary Outcome Measures

    1. Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days [Two - six months]

      The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.

    2. Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days [3 months]

      The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.

    3. Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) [3 months]

      Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.

    4. Time to 50% Reduction in Prostate-specific Antigen Levels [3 months]

      The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.

    5. Time to 90% Reduction in Prostate-specific Antigen Levels [3 months]

      The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.

    6. Evaluation of Liver Function Tests [3 months]

      The figures presents 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.

    7. Participants With Markedly Abnormal Change in Vital Signs and Body Weight [3 months]

      Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.

    Eligibility Criteria

    Criteria

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

    • Written informed consent obtained before any trial related procedures

    • Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy

    • ECOG score to be equal to or above 2

    • Testosterone level within age-specific normal range

    • PSA value equal to or above 2 ng/ml

    • Life expectancy of at least 6 months

    Exclusion Criteria:

    • Previous or current hormonal treatment of prostate cancer

    • Recent or current treatment with any drugs modifying the testosterone level

    • Candidate for curative treatment such as prostatectomy or radiotherapy

    • History of severe asthma, anaphylactic reactions or Quincke's Oedema

    • Hypersensitivity towards any component of FE200486

    • Cancer disease within the last ten years except for prostate cancer and some skin cancers

    • Signs of liver impairment shown as elevated serum ALT or serum bilirubin

    • Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results

    • Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator

    • Mental incapacity or language barrier

    • Having received an investigational product within the last 12 weeks preceding the trial

    • Previous participation in this trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet Copenhagen Denmark
    2 KAS Glostrup Glostrup Denmark
    3 KAS Herlev Herlev Denmark
    4 Marian Sairaala Helsinki Finland
    5 P-K Keskussairaala Joensuu Finland
    6 Vuorikadun lääkäriasema Kuopio Finland
    7 OYS Oulu Finland
    8 Kirugikeskus Seinäjoki Finland
    9 TAYS Tampere Finland
    10 Bajcsy-Zsilinszky Hospital, Urology Budapest Hungary
    11 Jahn Ferenc Dél Pesti Hospital, Urology Budapest Hungary
    12 Péterfy Hospital, Urology Budapest Hungary
    13 Bács-Kiskun County Hospital, Urology Kecskemét Hungary
    14 Hospital of Local Gov. Szeged, Urology Szeged Hungary
    15 MÁV Hospital, Urology Szolnok Hungary
    16 Sentralsykehuset i Rogland Stavanger Norway
    17 CF2 Hospital - Bucharest, Urology Bucharest Romania
    18 Dr. Th Burghele Hospital Bucharest Romania
    19 Fundeni Hospital - Bucharest, Urology Bucharest Romania
    20 County Hospital - Timisoara, Urology Timisoara Romania
    21 City Hospital #1, State Med Univ/Urology Moscow Russian Federation
    22 Institute of Urology of MoH Moscow Russian Federation
    23 Moscow City Hospital #60, Urology Moscow Russian Federation
    24 City Hospital #15, Urology Department St. Petersburg Russian Federation
    25 City Hospital #26, Urology Department St. Petersburg Russian Federation
    26 Sahlgrenska Universitetssjukehuset Göteborg Sweden
    27 Helsingborgs Lasaret Helsingborg Sweden
    28 Universitetssjukehuset, MAS Malmö Sweden
    29 Akademiska Sjukhuset Uppsala Uppsala Sweden
    30 University Hospital, Örebro Örebro Sweden

    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:
    NCT00818623
    Other Study ID Numbers:
    • FE200486 CS07
    First Posted:
    Jan 8, 2009
    Last Update Posted:
    May 23, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    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
    Intent-to-treat (ITT) Population 25 12 12 24 24 24 24 27
    COMPLETED 24 8 9 19 23 21 23 26
    NOT COMPLETED 2 4 4 5 4 3 4 1

    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]
    0-1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    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 (kilgram per square meter) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilgram 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)
    Serum prostate-specific antigen levels (nanogram per milliliter) [Median (Full Range) ]
    Median (Full Range) [nanogram per milliliter]
    42.5
    58.8
    109
    32.3
    46.9
    31.0
    31.9
    23.8
    37.9
    Serum testosterone levels (nanogram per milliliter) [Median (Full Range) ]
    Median (Full Range) [nanogram per milliliter]
    4.30
    3.10
    3.02
    4.64
    5.60
    4.02
    4.46
    3.68
    4.16
    Time since prostate cancer diagnosis (days) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [days]
    83.2
    (157)
    65.9
    (53.5)
    222
    (328)
    146
    (298)
    252
    (560)
    313
    (837)
    121
    (425)
    46.6
    (54.4)
    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 Time From Dosing Until Testosterone Levels >0.5 ng/mL
    Description Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    ITT population.
    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 24
    Median (95% Confidence Interval) [days]
    84
    63
    70
    140
    84
    140
    87.5
    133
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 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)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0000586
    Comments
    Method Log Rank
    Comments
    2. Secondary Outcome
    Title Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days
    Description The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.
    Time Frame Two - six months

    Outcome Measure Data

    Analysis Population Description
    ITT population.
    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 24
    Number [participants]
    21
    84%
    8
    66.7%
    6
    50%
    24
    100%
    18
    75%
    22
    91.7%
    15
    62.5%
    24
    88.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 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)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments
    Method Kruskal-Wallis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Degarelix 120mg (20mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 87.5
    Confidence Interval () 95%
    66.1 to 95.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Degarelix 120mg (40mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 66.7
    Confidence Interval () 95%
    33.7 to 86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Degarelix 160mg (40mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 54.5
    Confidence Interval () 95%
    22.9 to 78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Degarelix 200mg (40mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 100
    Confidence Interval () 95%
    85.8 to 100
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Degarelix 200mg (60mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 75
    Confidence Interval () 95%
    52.6 to 87.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Degarelix 240mg (40mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 95.7
    Confidence Interval () 95%
    72.9 to 99.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Degarelix 240mg (60mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 62.5
    Confidence Interval () 95%
    40.3 to 78.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Degarelix 320mg (60mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 88.9
    Confidence Interval () 95%
    69.4 to 96.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days
    Description The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    ITT population.
    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 24
    Number [participants]
    11
    44%
    4
    33.3%
    3
    25%
    20
    83.3%
    11
    45.8%
    18
    75%
    12
    50%
    19
    70.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 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)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments
    Method Kruskal-Wallis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Degarelix 120mg (20mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 45.8
    Confidence Interval () 95%
    25.6 to 64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Degarelix 120mg (40mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 38.1
    Confidence Interval () 95%
    12.1 to 64.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Degarelix 160mg (40mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 32.7
    Confidence Interval () 95%
    8.3 to 60.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Degarelix 200mg (40mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 83.3
    Confidence Interval () 95%
    61.5 to 93.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Degarelix 200mg (60mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 49.4
    Confidence Interval () 95%
    28.3 to 67.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Degarelix 240mg (40mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 82
    Confidence Interval () 95%
    58.8 to 92.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Degarelix 240mg (60mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 50
    Confidence Interval () 95%
    29.1 to 67.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Degarelix 320mg (60mg/mL)
    Comments Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage of participants castrated
    Estimated Value 70.4
    Confidence Interval () 95%
    49.4 to 83.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)
    Description Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    ITT population
    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 24
    Median (Full Range) [days]
    1
    1
    1.5
    1.5
    2
    1.5
    2
    1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 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)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0866
    Comments
    Method Log Rank
    Comments
    5. Secondary Outcome
    Title Time to 50% Reduction in Prostate-specific Antigen Levels
    Description The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    ITT population. Patients who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.
    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 24
    Median (Full Range) [days]
    14
    21
    14
    14
    14
    14
    14
    14
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 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)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.033
    Comments
    Method Log Rank
    Comments
    6. Secondary Outcome
    Title Time to 90% Reduction in Prostate-specific Antigen Levels
    Description The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    ITT population. Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.
    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 24
    Median (Full Range) [days]
    31.5
    35
    42
    35
    28
    42
    35
    45.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 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)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.131
    Comments
    Method Log Rank
    Comments
    7. Secondary Outcome
    Title Evaluation of Liver Function Tests
    Description The figures presents 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 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    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 24
    Abnormal alanine aminotransferase (ALAT)
    9
    36%
    2
    16.7%
    3
    25%
    7
    29.2%
    8
    33.3%
    4
    16.7%
    6
    25%
    6
    22.2%
    Abnormal aspartate aminotransferase
    6
    24%
    3
    25%
    1
    8.3%
    4
    16.7%
    7
    29.2%
    3
    12.5%
    5
    20.8%
    5
    18.5%
    Abnormal bilirubin
    2
    8%
    1
    8.3%
    0
    0%
    2
    8.3%
    0
    0%
    1
    4.2%
    0
    0%
    1
    3.7%
    ALAT >3x ULN
    2
    8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    4.2%
    1
    4.2%
    0
    0%
    ALAT >3x ULN, bilirubin >1.5x ULN
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8. Secondary 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 participants in each group with normal baseline and markedly abnormal value post-baseline.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes participants whose percent weight change from baseline fit the stated ranges.
    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 24
    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
    1
    4%
    0
    0%
    0
    0%
    1
    4.2%
    1
    4.2%
    0
    0%
    0
    0%
    1
    3.7%
    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%
    1
    8.3%
    3
    12.5%
    1
    4.2%
    2
    8.3%
    1
    4.2%
    2
    7.4%
    Heart rate <=50 and decrease >=15
    0
    0%
    1
    8.3%
    1
    8.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.7%
    Heart rate >=120 and increase >=15
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Body weight decrease of >=7 percent
    1
    4%
    1
    8.3%
    0
    0%
    2
    8.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Body weight increase of >=7 percent
    2
    8%
    1
    8.3%
    1
    8.3%
    2
    8.3%
    1
    4.2%
    0
    0%
    3
    12.5%
    1
    3.7%

    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 2/ (NaN) 2/ (NaN) 1/ (NaN) 2/ (NaN) 1/ (NaN) 4/ (NaN) 3/ (NaN) 4/ (NaN)
    Cardiac disorders
    Cardiac failure 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
    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
    Myocardial infarction 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
    Gastrointestinal disorders
    Inguinal hernia 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
    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
    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
    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
    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
    Pneumonia 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
    Injury, poisoning and procedural complications
    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%) 1
    Musculoskeletal and connective tissue disorders
    Inervertebral 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 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
    Metastases to liver 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
    Metastatic neoplasm 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
    Metastatic pain 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
    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
    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
    Spinal cord compression 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
    Completed suicide 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
    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
    Haematuria 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
    Respiratory, thoracic and mediastinal disorders
    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
    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 0/24 (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 14/ (NaN) 10/ (NaN) 7/ (NaN) 20/ (NaN) 14/ (NaN) 22/ (NaN) 10/ (NaN) 19/ (NaN)
    Cardiac disorders
    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 2/27 (7.4%) 2
    Atrial fibrillation 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
    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
    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 0/24 (0%) 0 0/27 (0%) 0
    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 0/24 (0%) 0 0/27 (0%) 0
    Gastrointestinal disorders
    Diarrhoea 1/25 (4%) 1 1/12 (8.3%) 1 0/12 (0%) 0 3/24 (12.5%) 3 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 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
    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 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
    Injection site pain 1/25 (4%) 1 2/12 (16.7%) 2 1/12 (8.3%) 1 2/24 (8.3%) 2 1/24 (4.2%) 1 1/24 (4.2%) 1 0/24 (0%) 0 0/27 (0%) 0
    Injection site erythema 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 3/24 (12.5%) 3 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/27 (3.7%) 1
    Fatigue 0/25 (0%) 0 0/12 (0%) 0 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
    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
    Chills 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
    Feeling of body temperature change 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
    Injection site induration 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
    Injection site pruritus 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
    Oedema peripheral 0/25 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 2 0/24 (0%) 0 0/24 (0%) 0 0/27 (0%) 0
    Injection site swelling 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
    Infections and infestations
    Urinary tract infection 3/25 (12%) 3 0/12 (0%) 0 0/12 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 3/24 (12.5%) 3 2/24 (8.3%) 2 2/27 (7.4%) 2
    Nasopharyngitis 1/25 (4%) 1 2/12 (16.7%) 2 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 1 0/24 (0%) 0 1/27 (3.7%) 1
    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
    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
    Investigations
    Blood alkaline phosphatase increased 3/25 (12%) 3 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
    Gamma-glutamyltransferase increased 3/25 (12%) 3 1/12 (8.3%) 1 0/12 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 1/24 (4.2%) 3 0/24 (0%) 0 0/27 (0%) 0
    Alanine aminotransferase increased 4/25 (16%) 4 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
    Aspartate aminotransferase increased 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
    Blood pressure 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 2/27 (7.4%) 3
    Hepatic enzyme increased 0/25 (0%) 0 1/12 (8.3%) 1 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
    Prostatic specific antigen increased 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
    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 0/25 (0%) 0 1/12 (8.3%) 2 0/12 (0%) 0 1/24 (4.2%) 1 3/24 (12.5%) 3 1/24 (4.2%) 1 1/24 (4.2%) 1 1/27 (3.7%) 1
    Arthralgia 1/25 (4%) 1 0/12 (0%) 0 1/12 (8.3%) 1 1/24 (4.2%) 1 0/24 (0%) 0 1/24 (4.2%) 2 1/24 (4.2%) 1 0/27 (0%) 0
    Bone pain 1/25 (4%) 1 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
    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 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
    Muscular weakness 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
    Headache 0/25 (0%) 0 2/12 (16.7%) 2 0/12 (0%) 0 3/24 (12.5%) 3 0/24 (0%) 0 3/24 (12.5%) 3 0/24 (0%) 0 0/27 (0%) 0
    Dizziness 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 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 2/25 (8%) 2 0/12 (0%) 0 1/12 (8.3%) 1 2/24 (8.3%) 2 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
    Nocturia 0/25 (0%) 0 0/12 (0%) 0 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
    Haematuria 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 2 0/24 (0%) 0 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 1/25 (4%) 1 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
    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 0/12 (0%) 0 5/24 (20.8%) 6 5/24 (20.8%) 5 5/24 (20.8%) 5 2/24 (8.3%) 2 1/27 (3.7%) 1
    Eczema 0/25 (0%) 0 1/12 (8.3%) 2 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
    Erythema 0/25 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 1/24 (4.2%) 2 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0 0/24 (0%) 0
    Vascular disorders
    Hot flush 4/25 (16%) 4 1/12 (8.3%) 1 3/12 (25%) 4 12/24 (50%) 12 6/24 (25%) 6 9/24 (37.5%) 9 4/24 (16.7%) 4 9/27 (33.3%) 9
    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 0/24 (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 Clinical Development Support
    Organization Ferring Pharmaceuticals
    Phone
    Email DK0-Disclosure@ferring.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00818623
    Other Study ID Numbers:
    • FE200486 CS07
    First Posted:
    Jan 8, 2009
    Last Update Posted:
    May 23, 2011
    Last Verified:
    May 1, 2011