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A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00451958
Collaborator
(none)
386
Enrollment
69
Locations
4
Arms
57
Duration (Months)
5.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.

Condition or Disease Intervention/Treatment Phase
  • Drug: Degarelix 80 mg / Degarelix 80 mg
  • Drug: Degarelix 160 mg / Degarelix 160 mg
  • Drug: Leuprolide 7.5 mg / Degarelix 80 mg
  • Drug: Leuprolide 7.5 mg / Degarelix 160 mg
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
386 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Degarelix 80 mg / Degarelix 80 mg

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.

Drug: Degarelix 80 mg / Degarelix 80 mg
Other Names:
  • Firmagon

    		•
    Experimental: Degarelix 160 mg / Degarelix 160 mg

    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

    Drug: Degarelix 160 mg / Degarelix 160 mg
    Other Names:
  • Firmagon

    		•
    Experimental: Leuprolide 7.5 mg / Degarelix 80 mg

    During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

    Drug: Leuprolide 7.5 mg / Degarelix 80 mg
    Other Names:
  • Firmagon
  • Lupron

    		•
    Experimental: Leuprolide 7.5 mg / Degarelix 160 mg

    During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

    Drug: Leuprolide 7.5 mg / Degarelix 160 mg
    Other Names:
  • Firmagon
  • Lupron

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [Up to 4 years of treatment]

      This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.

    2. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [Up to 4 years of treatment]

      This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.

    Secondary Outcome Measures

    1. Percentage of Participants With no Prostate-specific Antigen (PSA) Progression [Until all participants have received at least 5 years of treatment and at a frequency of every 3 months]

      PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).

    2. Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards [Until all participants have received at least 5 years of treatment and at a frequency of every 6 months]

      The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study. In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study.

    3. Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 [From time of switch to Day 56]

    4. Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 [From time of switch to Day 56]

    5. Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 [From time of switch to Day 56]

    6. Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 [From time of switch to Day 56]

    Eligibility Criteria

    Criteria

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

    • Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.

    • Signed informed consent

    • The patients must have completed the FE 200486 CS21 Study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology Centers Of Alabama Homewood Alabama United States
    2 South Orange County Medical Research Center Laguna Hills California United States
    3 Western Clinical Research Torrance California United States
    4 Urology Associates Research Englewood Colorado United States
    5 South Florida Medical Research Aventura Florida United States
    6 Investigational Site Ocala Florida United States
    7 Regional Urology Shreveport Louisiana United States
    8 Lawrenceville Urology Lawrenceville New Jersey United States
    9 Investigational Site Carmel New York United States
    10 North Urology Research Concord North Carolina United States
    11 Investigational Site Greensboro North Carolina United States
    12 State College Urologic Association State College Pennsylvania United States
    13 Urology San Antonio Research San Antonio Texas United States
    14 Seattle Urology Research Center Burien Washington United States
    15 Investigational Site Kentville Nova Scotia Canada
    16 The Female/Male Health Centres Barrie Ontario Canada
    17 Brantford Urology Research Brantford Ontario Canada
    18 Burlington Professional Centre Burlington Ontario Canada
    19 The Urology Research Centre Burlington Ontario Canada
    20 Investigational Site Newmarket Ontario Canada
    21 The Female/Male Health Centres Oakville Ontario Canada
    22 Urology South Shore Research Greenfields Quebec Canada
    23 Can-Med Clinical Research Inc Victoria Canada
    24 Urocentrum Brno Brno Czech Republic
    25 UROHELP - Bozetechova Brno Czech Republic
    26 Nemocnice Jindrichuv Hradec, a.s. Jindrichuv Hradec Czech Republic
    27 Fakultni Nemocnice Olomouc Olomouc Czech Republic
    28 Slezska nemocnice Opava Czech Republic
    29 Fakultni nemocnice v Motole, Prague5 Prague Czech Republic
    30 Vseobecna fakultni nemocnice v Praze, Prague2 Prague Czech Republic
    31 Klinikum Mannheim Universitätsklinikum GmbH Mannheim Germany
    32 Klinikum der Universität Regensburg Regensburg Germany
    33 Fövárosi Önkormányzat uzsoki utcai Kórház Budapest Hungary
    34 Dombóvári Szent Lukács Egészségügyi Kht. Dombóvár Hungary
    35 Petz Aladár Megyei Oktató Kórház Györ Hungary
    36 Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Miskolc Hungary
    37 Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft Miskolc Hungary
    38 Pécsi Tudományegyetem Pécs Hungary
    39 Investigational Site Szeged Hungary
    40 Investigational Site Acapulco Mexico
    41 Hospital Christus Muguerza del Parque Chihuahua, Chih. Mexico
    42 Investigational Sit Durango Mexico
    43 Hospital Aranda de la Parra , S.A. de C.V. Leon, GTO Mexico
    44 Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico, DF Mexico Mexico, DF Mexico
    45 Investigational Site Mexico, DF Mexico
    46 Consultorio Medico Zapopan, Jalisco Mexico
    47 Investigational Site Zapopan, Jalisco Mexico
    48 Investigational Site Ede Netherlands
    49 Investigational Site Eindhoven Netherlands
    50 Atrium MC Heerlen Netherlands
    51 Hospital Andres Grillasca Ponce Puerto Rico
    52 Investigational Site Arad Romania
    53 Fundeni Uronephrology and Renal Transplant Clinical Institute Bucharest Romania
    54 Investigational Site Bucharest Romania
    55 Sfantul Ioan" Emergency Clinical Hospital Bucharest Romania
    56 PROVITA 2000 Medical Center Constanta Romania
    57 Investigational Site Iasi Romania
    58 Sibiu Emergency Clinical County Hospital Sibiu Romania
    59 City Clinical Hospital #1 n.a. N.I.Pirogov Moscow Russian Federation
    60 City Clinical Hospital #60 Moscow Russian Federation
    61 Moscow State University of Medicine and Dentistry Moscow Russian Federation
    62 City Pokrovskaya Hospital St. Petersburg Russian Federation
    63 Investigational Site St. Petersburg Russian Federation
    64 St.Petersburg State Medical Academy n. a. I.I.Mechnikov St. Petersburg Russian Federation
    65 Dnipropetrovsk State Medical Academy Dnipropetrovsk Ukraine
    66 Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval Kharkiv Ukraine
    67 Kyiv City Clinical Hospital #3 Kyiv Ukraine
    68 Odesa State Medical University Odesa Ukraine
    69 Clatterbridge Centre For Oncology Bebington, Wirral United Kingdom

    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:
    NCT00451958
    Other Study ID Numbers:
    • FE200486 CS21A
    • 2006-006913-34
    First Posted:
    Mar 26, 2007
    Last Update Posted:
    Mar 21, 2013
    Last Verified:
    Mar 1, 2013
    Keywords provided by Ferring Pharmaceuticals
    Degarelix
    prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Leuprolide

    Study Results

    Participant Flow

    Recruitment Details All participants who completed the CS21 study (NCT00295750) were eligible to enrol into the CS21A extension study. Since the number of participants who completed this long-term study was low, no firm conclusions can be drawn from the results.
    Pre-assignment Detail Initially, participants treated with degarelix during CS21 continued to treatment and patients who received treatment with leuprolide during CS21 were re-randomised to one of the two degarelix treatment regimens. Following a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg for the rest of the study.
    Arm/Group Title Degarelix 80 mg / Degarelix 80 mg Degarelix 160 mg / Degarelix 160 mg Leuprolide 7.5 mg / Degarelix 80 mg Leuprolide 7.5 mg / Degarelix 160 mg Leuprolide 7.5 mg
    Arm/Group Description The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study. The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. When the main CS21 study was completed these patients were switched to treatment with degarelix 80 mg or 160 mg in the CS21A study.
    Period Title: CS21 (NCT00295750)
    STARTED 210 206 0 0 204
    COMPLETED 169 163 0 0 172
    NOT COMPLETED 41 43 0 0 32
    Period Title: CS21 (NCT00295750)
    STARTED 125 126 69 66 0
    COMPLETED 60 49 27 27 0
    NOT COMPLETED 65 77 42 39 0

    Baseline Characteristics

    Arm/Group Title Degarelix 80 mg / Degarelix 80 mg Degarelix 160 mg / Degarelix 160 mg Leuprolide 7.5 mg / Degarelix 80 mg Leuprolide 7.5 mg / Degarelix 160 mg Total
    Arm/Group Description The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study. The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. Total of all reporting groups
    Overall Participants 125 126 69 65 385
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    70.1
    (7.62)
    71.1
    (8.25)
    72.4
    (9.46)
    71.4
    (8.24)
    71.1
    (8.29)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    125
    100%
    126
    100%
    69
    100%
    65
    100%
    385
    100%
    Region of Enrollment (participants) [Number]
    United States
    12
    9.6%
    14
    11.1%
    13
    18.8%
    9
    13.8%
    48
    12.5%
    Hungary
    7
    5.6%
    9
    7.1%
    5
    7.2%
    5
    7.7%
    26
    6.8%
    Czech Republic
    11
    8.8%
    12
    9.5%
    6
    8.7%
    8
    12.3%
    37
    9.6%
    Mexico
    15
    12%
    17
    13.5%
    10
    14.5%
    7
    10.8%
    49
    12.7%
    Canada
    4
    3.2%
    5
    4%
    5
    7.2%
    4
    6.2%
    18
    4.7%
    Ukraine
    11
    8.8%
    10
    7.9%
    7
    10.1%
    3
    4.6%
    31
    8.1%
    Romania
    36
    28.8%
    39
    31%
    16
    23.2%
    15
    23.1%
    106
    27.5%
    Russian Federation
    26
    20.8%
    19
    15.1%
    6
    8.7%
    13
    20%
    64
    16.6%
    Netherlands
    2
    1.6%
    0
    0%
    0
    0%
    1
    1.5%
    3
    0.8%
    Germany
    0
    0%
    0
    0%
    1
    1.4%
    0
    0%
    1
    0.3%
    United Kingdom
    1
    0.8%
    1
    0.8%
    0
    0%
    0
    0%
    2
    0.5%
    Body Weight (kilogram) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilogram]
    78.4
    (12.6)
    79.2
    (13.4)
    78.7
    (11.3)
    80.0
    (12.1)
    79.0
    (12.5)
    Body Mass Index (kilogram per square meter) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilogram per square meter]
    26.4
    (3.92)
    26.9
    (3.79)
    26.9
    (3.94)
    27.1
    (3.67)
    26.8
    (3.84)
    Gleason Score (participants) [Number]
    Gleason Score 2-4
    15
    12%
    17
    13.5%
    8
    11.6%
    11
    16.9%
    51
    13.2%
    Gleason Score 5-6
    37
    29.6%
    44
    34.9%
    25
    36.2%
    18
    27.7%
    124
    32.2%
    Gleason Score 7-10
    73
    58.4%
    63
    50%
    36
    52.2%
    36
    55.4%
    208
    54%
    Stage of Prostate Cancer (participants) [Number]
    Localised
    39
    31.2%
    36
    28.6%
    20
    29%
    19
    29.2%
    114
    29.6%
    Locally advanced
    46
    36.8%
    44
    34.9%
    18
    26.1%
    24
    36.9%
    132
    34.3%
    Metastatic
    23
    18.4%
    22
    17.5%
    21
    30.4%
    9
    13.8%
    75
    19.5%
    Not classifiable
    17
    13.6%
    24
    19%
    10
    14.5%
    13
    20%
    64
    16.6%
    Serum Testosterone Levels (nanograms per milliliter) [Median (Full Range) ]
    Median (Full Range) [nanograms per milliliter]
    4.63
    4.02
    4.32
    3.51
    4.23
    Serum Prostate-Specific Antigen (PSA) Levels (nanograms per milliliter) [Median (Full Range) ]
    Median (Full Range) [nanograms per milliliter]
    22.2
    22.5
    25.5
    14.0
    21.0

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
    Description This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
    Time Frame Up to 4 years of treatment

    Outcome Measure Data

    Analysis Population Description
    The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.
    Arm/Group Title Degarelix 80 mg / Degarelix 80 mg Degarelix 160 mg / Degarelix 160 mg Leuprolide 7.5 mg / Degarelix 80 mg Leuprolide 7.5 mg / Degarelix 160 mg
    Arm/Group Description The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study. The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    Measure Participants 125 126 69 66
    Diastolic blood pressure <=50 and decrease >=15
    3
    2.4%
    6
    4.8%
    3
    4.3%
    6
    9.2%
    Diastolic blood pressure >=105 and increase >=15
    3
    2.4%
    6
    4.8%
    4
    5.8%
    0
    0%
    Systolic blood pressure <=90 and decrease >=20
    4
    3.2%
    4
    3.2%
    5
    7.2%
    3
    4.6%
    Systolic blood pressure >=180 and increase >=20
    7
    5.6%
    13
    10.3%
    7
    10.1%
    4
    6.2%
    Heart rate <=50 and decrease >=15
    4
    3.2%
    3
    2.4%
    7
    10.1%
    2
    3.1%
    Heart rate >=120 and increase >=15
    1
    0.8%
    1
    0.8%
    1
    1.4%
    3
    4.6%
    Body weight decrease of >=7 percent
    15
    12%
    24
    19%
    21
    30.4%
    8
    12.3%
    Body weight increase of >=7 percent
    25
    20%
    14
    11.1%
    4
    5.8%
    5
    7.7%
    2. Primary Outcome
    Title Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
    Description This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.
    Time Frame Up to 4 years of treatment

    Outcome Measure Data

    Analysis Population Description
    The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.
    Arm/Group Title Degarelix 80 mg / Degarelix 80 mg Degarelix 160 mg / Degarelix 160 mg Leuprolide 7.5 mg / Degarelix 80 mg Leuprolide 7.5 mg / Degarelix 160 mg
    Arm/Group Description The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study. The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    Measure Participants 125 126 69 65
    S-Potassium (mmol/L) >=5.8
    11
    8.8%
    9
    7.1%
    6
    8.7%
    5
    7.7%
    S-Alanine aminotransferase (IU/L) >3xULN
    1
    0.8%
    6
    4.8%
    1
    1.4%
    0
    0%
    S-Alkaline phosphatase (IU/L) >3xULN+25% increase
    4
    3.2%
    5
    4%
    4
    5.8%
    2
    3.1%
    S-Creatinine (µmol/L) >=177
    12
    9.6%
    7
    5.6%
    5
    7.2%
    2
    3.1%
    S-Urea nitrogen (mmol/L) >=10.7
    6
    4.8%
    9
    7.1%
    5
    7.2%
    5
    7.7%
    B-Haematocrit (Ratio) <=0.37
    40
    32%
    47
    37.3%
    22
    31.9%
    17
    26.2%
    B-Haemoglobin (g/L) <=115
    12
    9.6%
    20
    15.9%
    9
    13%
    6
    9.2%
    B-Red blood cell count (10^12/L) <=3.5
    10
    8%
    15
    11.9%
    5
    7.2%
    3
    4.6%
    B-Eosinophils (%) >=10
    6
    4.8%
    7
    5.6%
    1
    1.4%
    1
    1.5%
    B-Lymphocytes (%) <=10
    8
    6.4%
    9
    7.1%
    10
    14.5%
    5
    7.7%
    3. Secondary Outcome
    Title Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
    Description PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).
    Time Frame Until all participants have received at least 5 years of treatment and at a frequency of every 3 months

    Outcome Measure Data

    Analysis Population Description
    CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).
    Arm/Group Title Degarelix 80 mg / Degarelix 80 mg Degarelix 160 mg / Degarelix 160 mg Leuprolide 7.5 mg / Degarelix 80 mg Leuprolide 7.5 mg / Degarelix 160 mg
    Arm/Group Description The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study. The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    Measure Participants 207 202 69 132
    Day 28
    100
    80%
    99.5
    79%
    98.6
    142.9%
    100
    153.8%
    Day 364
    91.1
    72.9%
    85.8
    68.1%
    82.6
    119.7%
    87.9
    135.2%
    Day 1960
    61.0
    48.8%
    58.7
    46.6%
    50.7
    73.5%
    73.8
    113.5%
    4. Secondary Outcome
    Title Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
    Description The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study. In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study.
    Time Frame Until all participants have received at least 5 years of treatment and at a frequency of every 6 months

    Outcome Measure Data

    Analysis Population Description
    CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).
    Arm/Group Title Degarelix 80 mg / Degarelix 80 mg Degarelix 160 mg / Degarelix 160 mg Leuprolide 7.5 mg / Degarelix 80 mg Leuprolide 7.5 mg / Degarelix 160 mg
    Arm/Group Description The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study. The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Leuprolide participants who dropped out during the first year (i.e. during CS21) were all attributed to what became the leuprolide 7.5 mg / degarelix 160 mg arm. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    Measure Participants 206 197 69 128
    Day 84
    99.5
    100
    98.6
    97.6
    Day 364
    97.2
    98.3
    97.
    96.0
    Day 1876
    82.0
    87.7
    84.1
    88.4
    5. Secondary Outcome
    Title Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56
    Description
    Time Frame From time of switch to Day 56

    Outcome Measure Data

    Analysis Population Description
    All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.
    Arm/Group Title Leuprolide 7.5 mg/ Degarelix 240/80 mg Leuprolide 7.5 mg/ Degarelix 240/160 mg
    Arm/Group Description During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    Measure Participants 69 64
    Baseline
    0.076
    0.074
    Day 3
    0.084
    0.068
    Day 7
    0.076
    0.066
    Day 14
    0.085
    0.073
    Day 28
    0.074
    0.074
    Day 56
    0.080
    0.077
    6. Secondary Outcome
    Title Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
    Description
    Time Frame From time of switch to Day 56

    Outcome Measure Data

    Analysis Population Description
    All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.
    Arm/Group Title Leuprolide 7.5 mg/ Degarelix 240/80 mg Leuprolide 7.5 mg/ Degarelix 240/160 mg
    Arm/Group Description During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    Measure Participants 69 65
    Baseline
    0.4
    0.4
    Day 3
    0.4
    0.3
    Day 7
    0.35
    0.4
    Day 14
    0.4
    0.3
    Day 28
    0.4
    0.5
    Day 56
    0.35
    0.4
    7. Secondary Outcome
    Title Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56
    Description
    Time Frame From time of switch to Day 56

    Outcome Measure Data

    Analysis Population Description
    All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.
    Arm/Group Title Leuprolide 7.5 mg/ Degarelix 240/80 mg Leuprolide 7.5 mg/ Degarelix 240/160 mg
    Arm/Group Description During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    Measure Participants 69 65
    Baseline
    0.035
    0.035
    Day 3
    0.035
    0.035
    Day 7
    0.035
    0.035
    Day 14
    0.035
    0.035
    Day 28
    0.035
    0.035
    Day 56
    0.035
    0.035
    8. Secondary Outcome
    Title Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56
    Description
    Time Frame From time of switch to Day 56

    Outcome Measure Data

    Analysis Population Description
    All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.
    Arm/Group Title Leuprolide 7.5 mg/ Degarelix 240/80 mg Leuprolide 7.5 mg/ Degarelix 240/160 mg
    Arm/Group Description During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    Measure Participants 69 65
    Baseline
    4.8
    4.4
    Day 3
    2.7
    2.8
    Day 7
    2.6
    2.6
    Day 14
    2.2
    2.3
    Day 28
    1.8
    1.7
    Day 56
    1.3
    1.55

    Adverse Events

    Time Frame From start of CS21A and up to 4.5 years.
    Adverse Event Reporting Description The population comprised all participants who were enrolled into CS21A and who received at least one dose of degarelix during the study.
    Arm/Group Title Degarelix 80 mg / Degarelix 80 mg Degarelix 160 mg / Degarelix 160 mg Leuprolide 7.5 mg / Degarelix 80 mg Leuprolide 7.5 mg / Degarelix 160 mg
    Arm/Group Description The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study. The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    All Cause Mortality
    Degarelix 80 mg / Degarelix 80 mg Degarelix 160 mg / Degarelix 160 mg Leuprolide 7.5 mg / Degarelix 80 mg Leuprolide 7.5 mg / Degarelix 160 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Degarelix 80 mg / Degarelix 80 mg Degarelix 160 mg / Degarelix 160 mg Leuprolide 7.5 mg / Degarelix 80 mg Leuprolide 7.5 mg / Degarelix 160 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 43/207 (20.8%) 60/202 (29.7%) 23/69 (33.3%) 22/66 (33.3%)
    Blood and lymphatic system disorders
    Anaemia 1/207 (0.5%) 5/202 (2.5%) 1/69 (1.4%) 1/66 (1.5%)
    Anaemia of malignant disease 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 1/66 (1.5%)
    Retroperitoneal lymphadenopathy 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Iron deficiency anaemia 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Cardiac disorders
    Myocardial infarction 3/207 (1.4%) 1/202 (0.5%) 0/69 (0%) 2/66 (3%)
    Acute myocardial infarction 2/207 (1%) 1/202 (0.5%) 0/69 (0%) 1/66 (1.5%)
    Angina unstable 0/207 (0%) 2/202 (1%) 0/69 (0%) 1/66 (1.5%)
    Cardiac arrest 2/207 (1%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Coronary artery disease 1/207 (0.5%) 1/202 (0.5%) 0/69 (0%) 1/66 (1.5%)
    Myocardial ischaemia 1/207 (0.5%) 0/202 (0%) 1/69 (1.4%) 1/66 (1.5%)
    Atrial fibrillation 0/207 (0%) 0/202 (0%) 2/69 (2.9%) 0/66 (0%)
    Cardiac failure 0/207 (0%) 2/202 (1%) 0/69 (0%) 0/66 (0%)
    Angina pectoris 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Atrioventricular block second degree 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Cardio-respiratory arrest 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Acute coronary syndrome 0/207 (0%) 1/202 (0.5%) 1/69 (1.4%) 0/66 (0%)
    Bradycardia 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Cardiac failure congestive 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Cardiopulmonary failure 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Myopericarditis 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Eye disorders
    Retinal haemorrhage 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Gastrointestinal disorders
    Inguinal hernia 1/207 (0.5%) 2/202 (1%) 0/69 (0%) 0/66 (0%)
    Peritonitis 1/207 (0.5%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Ascites 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Diverticular perforation 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Diverticulum intestinal haemorrhagic 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Faecaloma 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Gastrointestinal haemorrhage 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Gastrooesophageal reflux disease 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Nausea 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Oedematous pancreatitis 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Rectal stenosis 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Subileus 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Umbilical hernia 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Gastric haemorrhage 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Gastric ulcer haemorrhage 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Gastritis 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Inguinal hernia obstructive 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    General disorders
    Asthenia 0/207 (0%) 1/202 (0.5%) 2/69 (2.9%) 0/66 (0%)
    Non-cardiac chest pain 0/207 (0%) 1/202 (0.5%) 1/69 (1.4%) 0/66 (0%)
    Accidental death 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Chest pain 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Death 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Disease progression 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Feeling abnormal 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Multi-organ failure 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Oedema peripheral 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Pyrexia 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Hepatobiliary disorders
    Cholecystitis acute 2/207 (1%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Bile duct stenosis 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Bile duct stone 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Jaundice 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Infections and infestations
    Pneumonia 2/207 (1%) 2/202 (1%) 0/69 (0%) 1/66 (1.5%)
    Arthritis infective 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Bronchitis 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Cholecystitis infective 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Empyema 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Injection site abscess 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Psoas abscess 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Scrotal gangrene 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Septic shock 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Bronchopneumonia 1/207 (0.5%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Ear infection 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Gastroenteritis 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Lobar pneumonia 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Post procedural cellulitis 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Injury, poisoning and procedural complications
    Compression fracture 1/207 (0.5%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Femur fracture 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 1/66 (1.5%)
    Humerus fracture 1/207 (0.5%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Alcohol poisoning 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Ankle fracture 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Femoral neck fracture 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Head injury 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Postoperative ileus 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Overdose 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Spinal compression fracture 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Investigations
    Heart rate increased 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Blood creatinine increased 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    ECG signs of myocardial ischaemia 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Prostate examination abnormal 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Metabolism and nutrition disorders
    Diabetes mellitus 1/207 (0.5%) 1/202 (0.5%) 0/69 (0%) 1/66 (1.5%)
    Type 2 diabetes mellitus 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Dehydration 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/207 (0%) 0/202 (0%) 2/69 (2.9%) 0/66 (0%)
    Groin pain 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Intervertebral disc protrusion 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Osteoarthritis 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Pathological fracture 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Spinal column stenosis 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer 3/207 (1.4%) 4/202 (2%) 1/69 (1.4%) 2/66 (3%)
    Bladder cancer 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Colon cancer 1/207 (0.5%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Metastases to bone 1/207 (0.5%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Bile duct cancer 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Bladder cancer recurrent 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Bladder papilloma 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Colon cancer stage II 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Gastric neoplasm 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Lung neoplasm 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Metastases to biliary tract 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Metastases to liver 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Metastases to penis 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Neoplasm malignant 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Non-hodgkin's lymphoma unspecified histology indolent 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Squamus cell carcinoma of skin 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Malignant lymphoma unclassifiable high grade 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Malignant melanoma 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Pleural mesothelioma malignant 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Prostate cancer metastatic 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Squamus cell carcinoma 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Nervous system disorders
    Cerebrovascular accident 0/207 (0%) 2/202 (1%) 2/69 (2.9%) 1/66 (1.5%)
    Syncope 1/207 (0.5%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Transient ischaemic attack 0/207 (0%) 1/202 (0.5%) 1/69 (1.4%) 0/66 (0%)
    Cerebral haemorrhage 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Cerebral ischaemia 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Haemorrhagic stroke 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Hemiparesis 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Parkinson's disease 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Spinal cord compression 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Cerebral infarction 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Cerebrovascular insufficiency 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Hyperkinesia 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Psychiatric disorders
    Confusional state 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Renal and urinary disorders
    Urinary retention 1/207 (0.5%) 6/202 (3%) 2/69 (2.9%) 2/66 (3%)
    Calculus bladder 2/207 (1%) 1/202 (0.5%) 0/69 (0%) 1/66 (1.5%)
    Calculus ureteric 2/207 (1%) 0/202 (0%) 0/69 (0%) 2/66 (3%)
    Haematuria 1/207 (0.5%) 3/202 (1.5%) 0/69 (0%) 0/66 (0%)
    Renal failure acute 1/207 (0.5%) 2/202 (1%) 1/69 (1.4%) 0/66 (0%)
    Renal failure chronic 0/207 (0%) 2/202 (1%) 0/69 (0%) 1/66 (1.5%)
    Bladder obstruction 0/207 (0%) 2/202 (1%) 0/69 (0%) 0/66 (0%)
    Hydronephrosis 0/207 (0%) 2/202 (1%) 0/69 (0%) 0/66 (0%)
    Renal failure 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Ureteric stenosis 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Urinary incontinence 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Urethral obstruction 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Urethral stenosis 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Dyspnoea 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Pleural effusion 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Chronic obstructive pulmonary disease 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Respiratory failure 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Skin and subcutaneous tissue disorders
    Ecchymosis 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Surgical and medical procedures
    Transurethral prostatectomy 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Vascular disorders
    Deep vein thrombosis 0/207 (0%) 0/202 (0%) 2/69 (2.9%) 0/66 (0%)
    Hypertension 1/207 (0.5%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Aortic aneurysm 0/207 (0%) 0/202 (0%) 0/69 (0%) 1/66 (1.5%)
    Lymphoedema 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Pallor 0/207 (0%) 1/202 (0.5%) 0/69 (0%) 0/66 (0%)
    Varicose vein 0/207 (0%) 0/202 (0%) 1/69 (1.4%) 0/66 (0%)
    Hypotension 1/207 (0.5%) 0/202 (0%) 0/69 (0%) 0/66 (0%)
    Orthostatic hypotension 0/207 (0%) 1/202 (0.5%) 1/69 (1.4%) 0/66 (0%)
    Other (Not Including Serious) Adverse Events
    Degarelix 80 mg / Degarelix 80 mg Degarelix 160 mg / Degarelix 160 mg Leuprolide 7.5 mg / Degarelix 80 mg Leuprolide 7.5 mg / Degarelix 160 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 181/207 (87.4%) 177/202 (87.6%) 63/69 (91.3%) 58/66 (87.9%)
    Blood and lymphatic system disorders
    Anaemia 17/207 (8.2%) 18/202 (8.9%) 10/69 (14.5%) 6/66 (9.1%)
    Cardiac disorders
    Atrial fibrillation 2/207 (1%) 6/202 (3%) 4/69 (5.8%) 4/66 (6.1%)
    Myocardial infarction 4/207 (1.9%) 2/202 (1%) 1/69 (1.4%) 4/66 (6.1%)
    Ear and labyrinth disorders
    Vertigo 2/207 (1%) 4/202 (2%) 1/69 (1.4%) 6/66 (9.1%)
    Gastrointestinal disorders
    Diarrhoea 17/207 (8.2%) 13/202 (6.4%) 12/69 (17.4%) 10/66 (15.2%)
    Constipation 18/207 (8.7%) 12/202 (5.9%) 9/69 (13%) 2/66 (3%)
    Nausea 10/207 (4.8%) 15/202 (7.4%) 3/69 (4.3%) 6/66 (9.1%)
    Vomiting 4/207 (1.9%) 7/202 (3.5%) 6/69 (8.7%) 3/66 (4.5%)
    Dyspepsia 3/207 (1.4%) 8/202 (4%) 1/69 (1.4%) 3/66 (4.5%)
    Haemorrhoids 1/207 (0.5%) 5/202 (2.5%) 4/69 (5.8%) 0/66 (0%)
    General disorders
    Injection site pain 65/207 (31.4%) 67/202 (33.2%) 20/69 (29%) 16/66 (24.2%)
    Injection site erythema 40/207 (19.3%) 51/202 (25.2%) 10/69 (14.5%) 16/66 (24.2%)
    Pyrexia 20/207 (9.7%) 22/202 (10.9%) 8/69 (11.6%) 9/66 (13.6%)
    Injection site swelling 17/207 (8.2%) 16/202 (7.9%) 6/69 (8.7%) 4/66 (6.1%)
    Fatigue 12/207 (5.8%) 15/202 (7.4%) 9/69 (13%) 6/66 (9.1%)
    Asthenia 13/207 (6.3%) 13/202 (6.4%) 8/69 (11.6%) 3/66 (4.5%)
    Injection site nodule 13/207 (6.3%) 17/202 (8.4%) 4/69 (5.8%) 2/66 (3%)
    Injection site inflammation 7/207 (3.4%) 5/202 (2.5%) 6/69 (8.7%) 0/66 (0%)
    Chest pain 2/207 (1%) 3/202 (1.5%) 4/69 (5.8%) 0/66 (0%)
    Chills 16/207 (7.7%) 11/202 (5.4%) 3/69 (4.3%) 2/66 (3%)
    Injection site induration 9/207 (4.3%) 13/202 (6.4%) 1/69 (1.4%) 3/66 (4.5%)
    Oedema peripheral 8/207 (3.9%) 9/202 (4.5%) 4/69 (5.8%) 3/66 (4.5%)
    Infections and infestations
    Urinary tract infection 12/207 (5.8%) 10/202 (5%) 14/69 (20.3%) 10/66 (15.2%)
    Influenza 12/207 (5.8%) 10/202 (5%) 8/69 (11.6%) 2/66 (3%)
    Nasopharyngitis 11/207 (5.3%) 7/202 (3.5%) 5/69 (7.2%) 5/66 (7.6%)
    Bronchitis 8/207 (3.9%) 6/202 (3%) 4/69 (5.8%) 4/66 (6.1%)
    Upper respiratory tract infection 4/207 (1.9%) 10/202 (5%) 5/69 (7.2%) 3/66 (4.5%)
    Injury, poisoning and procedural complications
    Fall 6/207 (2.9%) 8/202 (4%) 4/69 (5.8%) 0/66 (0%)
    Investigations
    Weight decreased 20/207 (9.7%) 24/202 (11.9%) 19/69 (27.5%) 10/66 (15.2%)
    Alanine aminotransferase increased 19/207 (9.2%) 21/202 (10.4%) 6/69 (8.7%) 6/66 (9.1%)
    Prostatic specific antigen increased 16/207 (7.7%) 20/202 (9.9%) 10/69 (14.5%) 6/66 (9.1%)
    Aspartate aminotransferase increased 15/207 (7.2%) 14/202 (6.9%) 7/69 (10.1%) 5/66 (7.6%)
    Gamma-glutamyltransferase increased 8/207 (3.9%) 15/202 (7.4%) 7/69 (10.1%) 2/66 (3%)
    Blood creatinine increased 11/207 (5.3%) 9/202 (4.5%) 5/69 (7.2%) 4/66 (6.1%)
    Blood alkaline phosphatase increased 7/207 (3.4%) 11/202 (5.4%) 3/69 (4.3%) 2/66 (3%)
    Blood urea increased 9/207 (4.3%) 5/202 (2.5%) 4/69 (5.8%) 0/66 (0%)
    Weight increased 32/207 (15.5%) 25/202 (12.4%) 15/69 (21.7%) 14/66 (21.2%)
    Metabolism and nutrition disorders
    Decreased appetite 3/207 (1.4%) 4/202 (2%) 7/69 (10.1%) 1/66 (1.5%)
    Hypercholesterolaemia 13/207 (6.3%) 18/202 (8.9%) 3/69 (4.3%) 5/66 (7.6%)
    Musculoskeletal and connective tissue disorders
    Back pain 20/207 (9.7%) 20/202 (9.9%) 10/69 (14.5%) 8/66 (12.1%)
    Arthralgia 18/207 (8.7%) 14/202 (6.9%) 14/69 (20.3%) 7/66 (10.6%)
    Pain in extremity 6/207 (2.9%) 9/202 (4.5%) 7/69 (10.1%) 3/66 (4.5%)
    Osteoarthritis 8/207 (3.9%) 45/202 (22.3%) 4/69 (5.8%) 2/66 (3%)
    Muscle spasms 1/207 (0.5%) 5/202 (2.5%) 4/69 (5.8%) 2/66 (3%)
    Myalgia 3/207 (1.4%) 4/202 (2%) 2/69 (2.9%) 3/66 (4.5%)
    Osteoporosis 0/207 (0%) 5/202 (2.5%) 1/69 (1.4%) 3/66 (4.5%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer 12/207 (5.8%) 11/202 (5.4%) 5/69 (7.2%) 6/66 (9.1%)
    Basal cell carcinoma 3/207 (1.4%) 5/202 (2.5%) 1/69 (1.4%) 3/66 (4.5%)
    Metastases to bone 6/207 (2.9%) 7/202 (3.5%) 2/69 (2.9%) 4/66 (6.1%)
    Nervous system disorders
    Dizziness 13/207 (6.3%) 14/202 (6.9%) 5/69 (7.2%) 6/66 (9.1%)
    Headache 11/207 (5.3%) 10/202 (5%) 5/69 (7.2%) 5/66 (7.6%)
    Psychiatric disorders
    Insomnia 10/207 (4.8%) 9/202 (4.5%) 2/69 (2.9%) 8/66 (12.1%)
    Depression 3/207 (1.4%) 11/202 (5.4%) 4/69 (5.8%) 6/66 (9.1%)
    Renal and urinary disorders
    Urinary retention 5/207 (2.4%) 14/202 (6.9%) 7/69 (10.1%) 6/66 (9.1%)
    Haematuria 10/207 (4.8%) 11/202 (5.4%) 4/69 (5.8%) 3/66 (4.5%)
    Dysuria 5/207 (2.4%) 11/202 (5.4%) 6/69 (8.7%) 4/66 (6.1%)
    Calculus ureteric 2/207 (1%) 0/202 (0%) 0/69 (0%) 3/66 (4.5%)
    Cystitis noninfective 2/207 (1%) 2/202 (1%) 0/69 (0%) 3/66 (4.5%)
    Hydronephrosis 3/207 (1.4%) 5/202 (2.5%) 2/69 (2.9%) 4/66 (6.1%)
    Nocturia 6/207 (2.9%) 4/202 (2%) 2/69 (2.9%) 3/66 (4.5%)
    Reproductive system and breast disorders
    Erectile dysfunction 4/207 (1.9%) 4/202 (2%) 3/69 (4.3%) 5/66 (7.6%)
    Respiratory, thoracic and mediastinal disorders
    Cough 14/207 (6.8%) 8/202 (4%) 5/69 (7.2%) 2/66 (3%)
    Dyspnoea 6/207 (2.9%) 4/202 (2%) 1/69 (1.4%) 3/66 (4.5%)
    Vascular disorders
    Hot flush 62/207 (30%) 63/202 (31.2%) 20/69 (29%) 21/66 (31.8%)
    Hypertension 19/207 (9.2%) 27/202 (13.4%) 8/69 (11.6%) 5/66 (7.6%)

    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. Additional time may be required to allow Ferring to seek patent protection of the invention.

    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:
    NCT00451958
    Other Study ID Numbers:
    • FE200486 CS21A
    • 2006-006913-34
    First Posted:
    Mar 26, 2007
    Last Update Posted:
    Mar 21, 2013
    Last Verified:
    Mar 1, 2013