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Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00819156
Collaborator
(none)
189
Enrollment
39
Locations
6
Arms
19
Duration (Months)
4.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.

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 :
189 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months
Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
Jun 1, 2005
Actual Study Completion Date :
Sep 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Degarelix 200/80

Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.

Drug: degarelix
Degarelix was given as subcutaneous injections.
Other Names:
  • FE200486

    		•
    Experimental: Degarelix 200/120

    Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.

    Drug: degarelix
    Degarelix was given as subcutaneous injections.
    Other Names:
  • FE200486

    		•
    Experimental: Degarelix 200/160

    Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.

    Drug: degarelix
    Degarelix was given as subcutaneous injections.
    Other Names:
  • FE200486

    		•
    Experimental: Degarelix 240/80

    Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.

    Drug: degarelix
    Degarelix was given as subcutaneous injections.
    Other Names:
  • FE200486

    		•
    Experimental: Degarelix 240/120

    Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.

    Drug: degarelix
    Degarelix was given as subcutaneous injections.
    Other Names:
  • FE200486

    		•
    Experimental: Degarelix 240/160

    Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.

    Drug: degarelix
    Degarelix was given as subcutaneous injections.
    Other Names:
  • FE200486

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 [12 months]

      Number of patients who achieved a testosterone level considered a castration level.

    Secondary Outcome Measures

    1. Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28 [Day 28 - 364]

      Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.

    2. Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. [Day 28]

      The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.

    3. Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. [Day 3]

      The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.

    4. Days to 50 Percent Reduction in Prostate-Specific Antigen [Day 0 (post dose) to Day 364]

      Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.

    5. Days to 90 Percent Reduction in Prostate-Specific Antigen [Day 0 (post dose) to Day 364]

      Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.

    6. Days to Prostate-Specific Antigen Progression [Day 0 (post dose) to Day 364]

      Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.

    7. Median Serum Testosterone Levels [Day 0 (Baseline), Days 1,3,7,14, and 364]

    8. Median Prostate-specific Antigen Levels [Day 0 (Baseline), Days 3, 7, 14, and 364]

    9. Median Values of Di-Hydrotestosterone [Day 0 (Baseline), Days 1, 3, 7, 14, and 364]

    10. Median Values for Serum Luteinizing Hormone [Day 0 (Baseline), Days 1, 3, 7, 14, and 364]

    11. Median Values for Follicle Stimulation Hormone [Day 0 (Baseline), Days 1, 3, 7, 14, and 364]

    12. The Number of Patients With Abnormal Liver Function Tests [364 days]

      The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.

    13. The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight [Day 364]

      Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.

    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 prior to any study related procedures

    • Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy

    • 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, angioedema, angioneurotic oedema or Quincke's Oedema

    • Hypersensitivity towards any component of degarelix or mannitol

    • Cancer disease within the last 5 years except for prostate cancer and some skin cancers

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

    • Known hepatic disease

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

    • Clinically significant disorder including 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 precluding adequate understanding or cooperation

    • 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 UCL Saint Luc Brussels Belgium
    2 UZ Gent Gent Belgium
    3 UZ Gasthuisberg Leuven Belgium
    4 Vivantes Klinikum am Urban Berlin Germany
    5 Loretto Krankenhaus Freiburg Germany
    6 Euromed AG Klinik Fürth Germany
    7 Urologische Universitätsklinikum Mannheim Germany
    8 Bajcsy-Zsilinszky Hospital, Urology Budapest Hungary
    9 Jahn Ferenc Dél Pesti Hospital, Urology Budapest Hungary
    10 Pez Aladar County Hospital Györ Hungary
    11 BAZ County Hospital Miskolc Hungary
    12 Hospital of Local Gov. Szeged, Urology Szeged Hungary
    13 MÁV Hospital, Urology Szolnok Hungary
    14 AMC Amsterdam Netherlands
    15 Atrium MC Heerlen Netherlands
    16 Wojewódzki Szpital Specjalisttyczny Siedlce Poland
    17 Wojewódzki Szpital Specjalisttyczny Slupsk Poland
    18 CF2 Hospital Bucharest Romania
    19 Dr. Th Burghele Hospital Bucharest Romania
    20 Fundeni Hospital Bucharest Romania
    21 Sf. Ioan Hospital Bucharest Romania
    22 Botkin Clinical Hospital Moscow Russian Federation
    23 City Hospital #1 Moscow Russian Federation
    24 City Hospital #29 Moscow Russian Federation
    25 City Hospital #50 Moscow Russian Federation
    26 City Hospital #60 Moscow Russian Federation
    27 Institute of Urology of MoH Moscow Russian Federation
    28 "Andros" Urology Clinic St Petersburg Russian Federation
    29 City Hospital #15 St Petersburg Russian Federation
    30 City Hospital #26 St Petersburg Russian Federation
    31 Military Medical Academy, Urology St Petersburg Russian Federation
    32 Pavlov Medical School Outpatient St Petersburg Russian Federation
    33 Pavlov medical School, Urology St Petersburg Russian Federation
    34 Sct Petersburg State Medical Academy St Petersburg Russian Federation
    35 370 Clarke Road Glenwood, Durban South Africa
    36 Pretoria Urology Hospital Hatfield, Pretoria South Africa
    37 WITS Medical School Parktown South Africa
    38 401B Medical Centre Pietermaritzburg South Africa
    39 Sunninghill Clinic Sunninghill South Africa

    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:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00819156
    Other Study ID Numbers:
    • FE200486 CS12
    First Posted:
    Jan 8, 2009
    Last Update Posted:
    Dec 28, 2011
    Last Verified:
    Dec 1, 2011
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Two hundred and sixteen patients were screened. Twenty-seven were screening failures. Two randomized patients were not treated: one withdrew consent and the other had an elevated alanine aminotransferase value (an exclusion criteria found after randomization).
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Period Title: Overall Study
    STARTED 30 33 32 30 33 31
    Randomised and Treated (ITT Population) 30 32 32 30 33 30
    COMPLETED 20 23 26 28 27 23
    NOT COMPLETED 10 10 6 2 6 8

    Baseline Characteristics

    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160 Total
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Total of all reporting groups
    Overall Participants 30 32 32 30 33 30 187
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    7
    23.3%
    5
    15.6%
    5
    15.6%
    6
    20%
    7
    21.2%
    7
    23.3%
    37
    19.8%
    >=65 years
    23
    76.7%
    27
    84.4%
    27
    84.4%
    24
    80%
    26
    78.8%
    23
    76.7%
    150
    80.2%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    69.9
    (8.27)
    70.6
    (7.72)
    73.3
    (7.39)
    70.4
    (7.07)
    70.7
    (7.56)
    70.7
    (8.59)
    70.9
    (7.75)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    30
    100%
    32
    100%
    32
    100%
    30
    100%
    33
    100%
    30
    100%
    187
    100%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3%
    0
    0%
    1
    0.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    3.3%
    2
    6.3%
    1
    3.1%
    0
    0%
    2
    6.1%
    0
    0%
    6
    3.2%
    White
    29
    96.7%
    30
    93.8%
    31
    96.9%
    30
    100%
    30
    90.9%
    30
    100%
    180
    96.3%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Number of Patients at Each Stage of Prostate Cancer (patients) [Number]
    Localized
    8
    6
    6
    5
    11
    5
    41
    Locally advanced
    8
    11
    11
    12
    8
    10
    60
    Metastatic
    4
    8
    5
    5
    7
    7
    36
    Not classifiable
    10
    7
    10
    8
    7
    8
    50
    Patient Counts by Gleason Score (participants) [Number]
    unknown
    0
    0%
    0
    0%
    2
    6.3%
    0
    0%
    0
    0%
    0
    0%
    2
    1.1%
    2-4
    4
    13.3%
    10
    31.3%
    6
    18.8%
    9
    30%
    4
    12.1%
    3
    10%
    36
    19.3%
    5-6
    13
    43.3%
    10
    31.3%
    14
    43.8%
    10
    33.3%
    17
    51.5%
    12
    40%
    76
    40.6%
    7-10
    13
    43.3%
    12
    37.5%
    10
    31.3%
    11
    36.7%
    12
    36.4%
    15
    50%
    73
    39%
    Body Mass Index (kilograms per square meter) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilograms per square meter]
    26.4
    (3.5)
    26.4
    (3.74)
    25.9
    (4.46)
    27.7
    (5.3)
    26
    (3.28)
    25.3
    (2.73)
    26.3
    (3.94)
    Days Since Diagnosis of Prostate Cancer (days) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [days]
    493
    (849)
    122
    (230)
    375
    (1098)
    383
    (817)
    229
    (508)
    352
    (743)
    323
    (756)
    Median Serum Testosterone Level (nanogram / milliliter) [Median (Full Range) ]
    Median (Full Range) [nanogram / milliliter]
    4.47
    3.93
    4.79
    4.28
    4.07
    3.88
    4.13
    Serum Prostate-specific Antigen (nanogram / milliliter) [Median (Full Range) ]
    Median (Full Range) [nanogram / milliliter]
    15.2
    31.5
    31.5
    23.1
    35.3
    32
    27.6

    Outcome Measures

    1. Primary Outcome
    Title Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
    Description Number of patients who achieved a testosterone level considered a castration level.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    ITT population.
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 28 25 27 30 30 25
    Number [participants]
    17
    56.7%
    21
    65.6%
    26
    81.3%
    27
    90%
    27
    81.8%
    23
    76.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/80
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 61
    Confidence Interval () 95%
    41 to 78
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/120
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 84
    Confidence Interval () 95%
    64 to 95
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/160
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 96
    Confidence Interval () 95%
    81 to 100
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Degarelix 240/80
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 90
    Confidence Interval () 95%
    73 to 98
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Degarelix 240/120
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 90
    Confidence Interval () 95%
    73 to 98
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Degarelix 240/160
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 92
    Confidence Interval () 95%
    74 to 99
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
    2. Secondary Outcome
    Title Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28
    Description Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.
    Time Frame Day 28 - 364

    Outcome Measure Data

    Analysis Population Description
    ITT population of patients with testoterone measurements <=0.5 nanogram/milliliter at Day 28.
    Arm/Group Title Maintenance Dose of 80 Milligram Per Cycle Maintenance Dose of 120 Milligram Per Cycle Maintenance Dose of 160 Milligram Per Cycle
    Arm/Group Description The two treatment groups that have a maintenance dose of 80 milligram per cycle in cycles 2-13 have been combined. The two treatment groups that have a maintenance dose of 120 milligram per cycle in cycles 2-13 have been combined. The two treatment groups that have a maintenance dose of 160 milligram per cycle in cycles 2-13 have been combined.
    Measure Participants 48 50 49
    Number [participants]
    44
    146.7%
    48
    150%
    49
    153.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/80
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 92
    Confidence Interval () 95%
    80 to 98
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone (T) <=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T <=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/120
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 96
    Confidence Interval () 95%
    86 to 100
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone (T) <=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T <=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/160
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 100
    Confidence Interval () 95%
    93 to 100
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone (T) <=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T <=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
    3. Secondary Outcome
    Title Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.
    Description The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.
    Time Frame Day 28

    Outcome Measure Data

    Analysis Population Description
    ITT population.
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 30 32 32 30 33 30
    Number [participants]
    21
    70%
    29
    90.6%
    31
    96.9%
    29
    96.7%
    31
    93.9%
    27
    90%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/80
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 70
    Confidence Interval () 95%
    51 to 85
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/120
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 91
    Confidence Interval () 95%
    75 to 98
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/160
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 97
    Confidence Interval () 95%
    84 to 100
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Degarelix 240/80
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 97
    Confidence Interval () 95%
    83 to 100
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Degarelix 240/120
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 94
    Confidence Interval () 95%
    80 to 99
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Degarelix 240/160
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 93
    Confidence Interval () 95%
    77 to 99
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    4. Secondary Outcome
    Title Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.
    Description The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.
    Time Frame Day 3

    Outcome Measure Data

    Analysis Population Description
    ITT population.
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 30 32 32 30 33 30
    Number [participants]
    25
    83.3%
    30
    93.8%
    27
    84.4%
    28
    93.3%
    30
    90.9%
    28
    93.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/80
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 83
    Confidence Interval () 95%
    65 to 94
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/120
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 94
    Confidence Interval () 95%
    79 to 99
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/160
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 87
    Confidence Interval () 95%
    70 to 96
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Degarelix 240/80
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 93
    Confidence Interval () 95%
    78 to 99
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Degarelix 240/120
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 91
    Confidence Interval () 95%
    76 to 98
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Degarelix 240/160
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 93
    Confidence Interval () 95%
    78 to 99
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
    5. Secondary Outcome
    Title Days to 50 Percent Reduction in Prostate-Specific Antigen
    Description Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.
    Time Frame Day 0 (post dose) to Day 364

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 30 32 32 30 33 30
    Median (Full Range) [days]
    14
    14
    14
    14
    14
    14
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/80, Degarelix 200/120, Degarelix 200/160, Degarelix 240/80, Degarelix 240/120, Degarelix 240/160
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0933
    Comments
    Method Log Rank
    Comments
    6. Secondary Outcome
    Title Days to 90 Percent Reduction in Prostate-Specific Antigen
    Description Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.
    Time Frame Day 0 (post dose) to Day 364

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 30 32 32 30 33 30
    Median (Full Range) [days]
    56
    56
    56
    56
    56
    56
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/80, Degarelix 200/120, Degarelix 200/160, Degarelix 240/80, Degarelix 240/120, Degarelix 240/160
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.165
    Comments
    Method Log Rank
    Comments
    7. Secondary Outcome
    Title Days to Prostate-Specific Antigen Progression
    Description Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.
    Time Frame Day 0 (post dose) to Day 364

    Outcome Measure Data

    Analysis Population Description
    Number of patients with PSA progression in the six groups n=0,3,1,4,4,2. Since no patients in the 200/80 group experience PSA progression the Days to progression could not be calculated.
    Arm/Group Title Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 32 32 30 33 30
    Median (Full Range) [days]
    224
    308
    280
    224
    140
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Degarelix 200/80, Degarelix 200/120, Degarelix 200/160, Degarelix 240/80, Degarelix 240/120
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.429
    Comments
    Method Log Rank
    Comments
    8. Secondary Outcome
    Title Median Serum Testosterone Levels
    Description
    Time Frame Day 0 (Baseline), Days 1,3,7,14, and 364

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 30 32 32 30 33 30
    Day 0 (Baseline)
    4.47
    3.93
    4.79
    4.28
    4.07
    3.88
    Day 1 (n=30,32,32,30,33,30)
    0.654
    0.436
    0.465
    0.563
    0.453
    0.576
    Day 3 (n=30,32,31,30,33,30)
    0.308
    0.26
    0.281
    0.265
    0.268
    0.261
    Day 7 (n=30,32,32,30,33,28)
    0.283
    0.237
    0.198
    0.193
    0.216
    0.207
    Day 14 (n=30,32,32,30,33,29)
    0.173
    0.144
    0.122
    0.152
    0.134
    0.126
    Day 364 (n=20,23,26,28,27,23)
    0.137
    0.124
    0.105
    0.126
    0.12
    0.124
    9. Secondary Outcome
    Title Median Prostate-specific Antigen Levels
    Description
    Time Frame Day 0 (Baseline), Days 3, 7, 14, and 364

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 30 32 32 30 33 30
    Day 0 (Baseline)
    15.2
    31.5
    31.5
    23.1
    35.3
    32
    Day 3 (n=29,30,28,29,33,28)
    13.7
    29.9
    27.8
    22.2
    26.3
    25.2
    Day 7 (n=30,32,32,30,33,28)
    10.6
    18.5
    16.5
    14.8
    20.8
    16.9
    Day 14 (n=29,31,32,29,33,28)
    7.9
    10.9
    9.9
    7.1
    13.4
    8.35
    Day 364 (n=20,23,26,28,27,22)
    0.45
    0.6
    0.95
    0.9
    0.8
    0.3
    10. Secondary Outcome
    Title Median Values of Di-Hydrotestosterone
    Description
    Time Frame Day 0 (Baseline), Days 1, 3, 7, 14, and 364

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 30 32 32 30 33 30
    Day 0 (Baseline; n=25,30,26,23,23,25)
    430
    330
    310
    330
    350
    290
    Day 1 (n=23,27,25,24,26,24)
    130
    95
    110
    130
    110
    115
    Day 3 (n=23,27,25,25,27,25)
    82
    67
    70
    66
    73
    67
    Day 7 (n=26,30,24,26,30,22)
    63
    65
    61.5
    56.5
    61
    77.5
    Day 14 (n=19,27,25,23,25,27)
    68
    51
    42
    57
    59
    53
    Day 364 (n=17,21,20,25,25,21)
    41
    39
    34
    40
    39
    40
    11. Secondary Outcome
    Title Median Values for Serum Luteinizing Hormone
    Description
    Time Frame Day 0 (Baseline), Days 1, 3, 7, 14, and 364

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 30 32 32 30 33 30
    Day 0 (Baseline)
    3.8
    4
    5.05
    5.6
    3.9
    6
    Day 1 (n=28,30,32,28,31,30)
    0.8
    0.65
    0.7
    0.9
    0.7
    0.75
    Day 3 (n=29,30,28,29,33,28)
    0.5
    0.5
    0.5
    0.5
    0.4
    0.55
    Day 7 (n=30,32,32,30,33,28)
    0.7
    0.5
    0.6
    0.5
    0.5
    0.75
    Day 14 (n=29,31,32,29,33,28)
    0.5
    0.3
    0.35
    0.3
    0.3
    0.3
    Day 364 (n=20,23,26,28,27,22)
    0.3
    0.3
    0.2
    0.4
    0.2
    0.3
    12. Secondary Outcome
    Title Median Values for Follicle Stimulation Hormone
    Description
    Time Frame Day 0 (Baseline), Days 1, 3, 7, 14, and 364

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 30 32 32 30 33 30
    Day 0 (Baseline)
    8.35
    9.25
    9
    9.7
    7
    10.2
    Day 1 (n=28,30,32,28,31,30)
    5.15
    5.65
    5.35
    6.2
    4.4
    5.9
    Day 3 (n=29,30,28,29,33,28)
    2.9
    3.15
    3.25
    3.3
    2.5
    3.1
    Day 7 (n=30,32,32,30,33,28)
    2.7
    1.95
    1.85
    1.85
    1.4
    2.55
    Day 14 (n=29,31,32,29,33,28)
    1.6
    1.1
    0.9
    0.8
    0.7
    0.95
    Day 364 (n=20,23,26,28,27,22)
    1.8
    1.5
    1.45
    1.75
    1.1
    2.2
    13. Secondary Outcome
    Title The Number of Patients With Abnormal Liver Function Tests
    Description The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.
    Time Frame 364 days

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 30 32 32 30 33 30
    Abnormal alanine aminotransferase (ALT)
    6
    20%
    10
    31.3%
    15
    46.9%
    13
    43.3%
    8
    24.2%
    9
    30%
    Abnormal aspartate aminotransferase
    7
    23.3%
    10
    31.3%
    15
    46.9%
    8
    26.7%
    13
    39.4%
    13
    43.3%
    Abnormal bilirubin
    2
    6.7%
    5
    15.6%
    1
    3.1%
    2
    6.7%
    5
    15.2%
    1
    3.3%
    ALT >3x ULN
    3
    10%
    8
    25%
    12
    37.5%
    13
    43.3%
    7
    21.2%
    8
    26.7%
    ALT>3x ULN and bilirubin >1.5x ULN
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    14. Secondary Outcome
    Title The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
    Description Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.
    Time Frame Day 364

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    Measure Participants 30 32 32 30 33 30
    Diastolic blood pressure <=50 and decrease >=15
    0
    0%
    0
    0%
    0
    0%
    2
    6.7%
    2
    6.1%
    2
    6.7%
    Diastolic blood pressure >=105 and increase >=15
    3
    10%
    3
    9.4%
    4
    12.5%
    3
    10%
    0
    0%
    2
    6.7%
    Pulse <=50 and decrease >=15 from baseline
    0
    0%
    2
    6.3%
    0
    0%
    2
    6.7%
    1
    3%
    1
    3.3%
    Pulse >=120 and increase of >=15 from baseline
    0
    0%
    0
    0%
    0
    0%
    1
    3.3%
    0
    0%
    0
    0%
    Systolic blood pressure <=90 and decrease >=20
    0
    0%
    0
    0%
    1
    3.1%
    0
    0%
    0
    0%
    0
    0%
    Systolic blood pressure >=180 and increase >=20
    3
    10%
    2
    6.3%
    4
    12.5%
    0
    0%
    3
    9.1%
    2
    6.7%
    Weight decrease of >=7% from baseline
    0
    0%
    1
    3.1%
    1
    3.1%
    3
    10%
    1
    3%
    0
    0%
    Weight increase of >=7% from baseline
    3
    10%
    4
    12.5%
    6
    18.8%
    5
    16.7%
    4
    12.1%
    1
    3.3%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    Arm/Group Description Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
    All Cause Mortality
    Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    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)
    Serious Adverse Events
    Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    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 3/ (NaN) 6/ (NaN) 4/ (NaN) 4/ (NaN) 6/ (NaN) 4/ (NaN)
    Blood and lymphatic system disorders
    Anaemia 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 1/30 (3.3%) 1
    Cardiac disorders
    Acute myocardial infarction 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 1/30 (3.3%) 1
    Angina pectoris 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1 0/33 (0%) 0 0/30 (0%) 0
    Angina unstable 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Atrioventricular block complete 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 1/33 (3%) 1 0/30 (0%) 0
    Cardiac failure 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Coronary artery stenosis 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Myocardial infarction 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Supraventricular tachycardia 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1 0/33 (0%) 0 0/30 (0%) 0
    Eye disorders
    Corneal defect 0/30 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Ulcerative keratitis 0/30 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    General disorders
    Disease progression 1/30 (3.3%) 1 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 1/30 (3.3%) 1
    Infections and infestations
    Bronchopneumonia 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Gastroenteritis viral 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 1/33 (3%) 1 0/30 (0%) 0
    Pneumonia 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Investigations
    Alanine aminotransferase increased 1/30 (3.3%) 1 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Aspartate aminotransferase increased 1/30 (3.3%) 1 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Blood alkaline phosphatase increased 1/30 (3.3%) 1 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Gamma-glutamyltransferase increased 1/30 (3.3%) 1 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Metabolism and nutrition disorders
    Cachexia 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 1/30 (3.3%) 1
    Musculoskeletal and connective tissue disorders
    Back pain 1/30 (3.3%) 1 0/32 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Intervertebral disc compression 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 1/33 (3%) 1 0/30 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to bone 0/30 (0%) 0 1/32 (3.1%) 1 1/32 (3.1%) 1 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Prostate cancer 0/30 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0 0/33 (0%) 0 1/30 (3.3%) 1
    Acoustic neuroma 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 1/33 (3%) 1 0/30 (0%) 0
    Laryngeal cancer 0/30 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 2 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Metastases to lymph nodes 0/30 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Metastases to penis 0/30 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Squamous cell carcinoma 1/30 (3.3%) 1 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Nervous system disorders
    Cerebrovascular accident 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 2/33 (6.1%) 2 0/30 (0%) 0
    Ischaemic stroke 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Spinal cord compression 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Psychiatric disorders
    Depression 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1 0/33 (0%) 0 0/30 (0%) 0
    Suicide attempt 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 1/33 (3%) 1 0/30 (0%) 0
    Renal and urinary disorders
    Hydronephrosis 1/30 (3.3%) 1 0/32 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1 0/33 (0%) 0 0/30 (0%) 0
    Urinary retention 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 1/30 (3.3%) 1 0/33 (0%) 0 0/30 (0%) 0
    Anuria 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 1/30 (3.3%) 1
    Calculus bladder 0/30 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Haematuria 1/30 (3.3%) 1 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Ureteric obstruction 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 1/30 (3.3%) 1
    Vascular disorders
    Hypertension 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 1/30 (3.3%) 2
    Other (Not Including Serious) Adverse Events
    Degarelix 200/80 Degarelix 200/120 Degarelix 200/160 Degarelix 240/80 Degarelix 240/120 Degarelix 240/160
    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 17/ (NaN) 21/ (NaN) 24/ (NaN) 19/ (NaN) 23/ (NaN) 20/ (NaN)
    Cardiac disorders
    Atrial fibrillation 0/30 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 2/30 (6.7%) 2
    Atrioventricular block first degree 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 2/30 (6.7%) 2 1/33 (3%) 1 0/30 (0%) 0
    Gastrointestinal disorders
    Diarrhoea 1/30 (3.3%) 2 3/32 (9.4%) 4 2/30 (6.7%) 2 0/30 (0%) 0 1/33 (3%) 1 2/30 (6.7%) 2
    Constipation 1/30 (3.3%) 1 0/32 (0%) 0 0/32 (0%) 0 2/30 (6.7%) 2 0/33 (0%) 0 1/30 (3.3%) 1
    General disorders
    Injection site pain 1/30 (3.3%) 1 3/32 (9.4%) 3 6/32 (18.8%) 17 0/30 (0%) 0 6/33 (18.2%) 11 2/30 (6.7%) 2
    Fatigue 2/30 (6.7%) 2 1/32 (3.1%) 1 2/32 (6.3%) 3 3/30 (10%) 4 1/33 (3%) 1 2/30 (6.7%) 2
    Injection site swelling 0/30 (0%) 0 2/32 (6.3%) 4 2/32 (6.3%) 7 0/30 (0%) 0 1/33 (3%) 3 1/30 (3.3%) 1
    Pyrexia 3/30 (10%) 4 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 2/30 (6.7%) 5
    Injection site erythema 0/30 (0%) 0 0/32 (0%) 0 2/32 (6.3%) 2 0/30 (0%) 0 1/33 (3%) 1 1/30 (3.3%) 1
    Asthenia 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 2/33 (6.1%) 2 1/30 (3.3%) 1
    Injection site inflammation 0/30 (0%) 0 2/32 (6.3%) 2 1/32 (3.1%) 1 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Infections and infestations
    Urinary tract infection 2/30 (6.7%) 2 2/32 (6.3%) 2 2/32 (6.3%) 4 2/30 (6.7%) 2 2/33 (6.1%) 2 1/30 (3.3%) 1
    Influenza 1/30 (3.3%) 1 0/32 (0%) 0 2/32 (6.3%) 2 0/30 (0%) 0 1/33 (3%) 1 2/30 (6.7%) 2
    Nasopharyngitis 2/30 (6.7%) 3 0/32 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1 2/33 (6.1%) 2 1/30 (3.3%) 1
    Pneumonia 1/30 (3.3%) 1 0/32 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1 0/33 (0%) 0 2/30 (6.7%) 2
    Bronchitis 0/30 (0%) 0 0/32 (0%) 0 2/32 (6.3%) 2 0/30 (0%) 0 0/33 (0%) 0 1/30 (3.3%) 1
    Investigations
    Weight increase 1/30 (3.3%) 1 3/32 (9.4%) 3 4/32 (12.5%) 4 4/30 (13.3%) 4 3/33 (9.1%) 3 2/30 (6.7%) 2
    Alanine aminotransferase increased 2/30 (6.7%) 2 1/32 (3.1%) 1 3/32 (9.4%) 4 0/30 (0%) 0 1/33 (3%) 3 1/30 (3.3%) 1
    Blood alkaline phosphatase increased 2/30 (6.7%) 2 0/32 (0%) 0 2/32 (6.3%) 3 0/30 (0%) 0 1/33 (3%) 1 1/30 (3.3%) 1
    Aspartate aminotransferase increased 1/30 (3.3%) 1 0/32 (0%) 0 2/32 (6.3%) 2 0/30 (0%) 0 1/33 (3%) 3 1/30 (3.3%) 1
    Blood urea increased 0/30 (0%) 0 0/32 (0%) 0 2/32 (6.3%) 2 2/30 (6.7%) 3 0/33 (0%) 0 0/32 (0%) 0
    Blood creatinine increased 0/30 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1 2/30 (6.7%) 2 0/33 (0%) 0 0/30 (0%) 0
    Weight decreased 0/30 (0%) 0 0/32 (0%) 0 2/32 (6.3%) 2 0/30 (0%) 0 1/33 (3%) 1 0/30 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 1/30 (3.3%) 1 3/32 (9.4%) 3 1/32 (3.1%) 1 1/30 (3.3%) 1 2/33 (6.1%) 2 1/30 (3.3%) 1
    Arthralgia 2/30 (6.7%) 2 0/32 (0%) 0 2/32 (6.3%) 3 0/30 (0%) 0 0/33 (0%) 0 2/30 (6.7%) 4
    Pain in extremity 0/30 (0%) 0 1/32 (3.1%) 1 1/32 (3.1%) 2 2/30 (6.7%) 3 2/33 (6.1%) 2 0/30 (0%) 0
    Nervous system disorders
    Headache 0/30 (0%) 0 0/32 (0%) 0 2/32 (6.3%) 2 2/30 (6.7%) 2 0/33 (0%) 0 2/30 (6.7%) 3
    Syncope vasovagal 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 2/30 (6.7%) 2 0/33 (0%) 0 0/30 (0%) 0
    Psychiatric disorders
    Insomnia 1/30 (3.3%) 1 1/32 (3.1%) 1 3/32 (9.4%) 3 0/30 (0%) 0 0/33 (0%) 0 1/30 (3.3%) 1
    Anxiety 0/30 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1 1/30 (3.3%) 1 2/33 (6.1%) 2 1/30 (3.3%) 1
    Renal and urinary disorders
    Haematuria 0/30 (0%) 0 0/32 (0%) 0 2/32 (6.3%) 2 1/30 (3.3%) 1 0/33 (0%) 0 0/30 (0%) 0
    Urinary tract obstruction 0/30 (0%) 0 0/32 (0%) 0 0/32 (0%) 0 2/30 (6.7%) 2 0/33 (0%) 0 0/30 (0%) 0
    Reproductive system and breast disorders
    Erectile dysfunction 2/30 (6.7%) 2 1/32 (3.1%) 1 2/32 (6.3%) 2 1/30 (3.3%) 1 0/33 (0%) 0 1/30 (3.3%) 1
    Testicular atrophy 2/30 (6.7%) 2 0/32 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0 1/33 (3%) 1 0/30 (0%) 0
    Gynaecomastia 2/30 (6.7%) 2 0/32 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1 0/33 (0%) 0 0/30 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 2/30 (6.7%) 2 1/32 (3.1%) 1 2/32 (6.3%) 3 1/30 (3.3%) 1 0/33 (0%) 0 3/30 (10%) 4
    Dyspnoea 0/30 (0%) 0 2/32 (6.3%) 3 0/32 (0%) 0 0/30 (0%) 0 1/33 (3%) 1 1/30 (3.3%) 1
    Epistaxis 1/30 (3.3%) 2 0/32 (0%) 0 2/32 (6.3%) 2 0/30 (0%) 0 0/33 (0%) 0 0/30 (0%) 0
    Skin and subcutaneous tissue disorders
    Alopecia 0/30 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1 1/30 (3.3%) 1 3/33 (9.1%) 3 0/30 (0%) 0
    Hyperhidrosis 1/30 (3.3%) 1 0/32 (0%) 0 2/32 (6.3%) 2 1/30 (3.3%) 2 1/33 (3%) 1 0/30 (0%) 0
    Pruritus 2/30 (6.7%) 2 0/32 (0%) 0 0/32 (0%) 0 0/30 (0%) 0 0/33 (0%) 0 1/30 (3.3%) 1
    Vascular disorders
    Hot flush 14/30 (46.7%) 16 8/32 (25%) 8 10/32 (31.3%) 13 11/30 (36.7%) 14 9/33 (27.3%) 9 10/30 (33.3%) 10

    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:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00819156
    Other Study ID Numbers:
    • FE200486 CS12
    First Posted:
    Jan 8, 2009
    Last Update Posted:
    Dec 28, 2011
    Last Verified:
    Dec 1, 2011