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    Clinical Trial Results:
    A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients with Prostate Cancer

    Summary
    EudraCT number
    		 2015-000357-20
    Trial protocol
    		 DE   FR   FI  
    Global end of trial date
    22 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Aug 2018
    First version publication date
    10 Aug 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    000184
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02526784
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ferring Pharmaceuticals
    Sponsor organisation address
    Kay Fiskers Plads 11, Copenhagen, Denmark, DK-2300
    Public contact
    Clinical Development Support, Ferring Pharmaceuticals A/S, DK0-Disclosure@ferring.com
    Scientific contact
    Clinical Development Support, Ferring Pharmaceuticals A/S, DK0-Disclosure@ferring.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to compare the severity of injection site reaction related pain following degarelix subcutaneous (SC) administrations with two different injection techniques and intramuscular (IM) administration in prostate cancer subjects during the 7-month trial period.
    Protection of trial subjects
    During the trial, the investigator followed-up on each adverse event until it was resolved or until the medical condition of the subject was stable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Dec 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 33
    Country: Number of subjects enrolled
    France: 26
    Country: Number of subjects enrolled
    Germany: 61
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    15
    From 65 to 84 years
    100
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 12 medical centres in Europe. The participating subjects were recruited among the subjects attending the clinics included in the trial.

    Pre-assignment
    Screening details
    		 A total of 122 subjects were screened, of which 2 subjects were screening failures. The reasons for screening failure were- subject not fulfilling inclusion/exclusion criteria (N=1) and subject withdrew consent (N=1).

    Period 1
    Period 1 title
    Overall Trial Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The trial was not blinded due to different injection techniques (standard and optimised), administration routes (SC and IM), and injection areas (abdominal wall and ventrogluteal muscle). However, subjects randomised to SC injections (standard or optimised) were blinded with regards to the SC injection technique used for investigational medicinal product (IMP) administration. The SC standard injections and SC optimised injections were not given by the same IMP administrator.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard SC injection
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Degarelix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Starting dose of 240 mg (40 mg/mL) at Month 0 followed by 6 maintenance doses of 80 mg (20 mg/mL) at monthly intervals (240/80 mg dose regimen), administered using standard SC technique.

    Arm title
    		 Optimised SC injection
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Degarelix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Starting dose of 240 mg (40 mg/mL) at Month 0 followed by 6 maintenance doses of 80 mg (20 mg/mL) at monthly intervals (240/80 mg dose regimen), administered using optimised SC technique.

    Arm title
    		 IM injection
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Degarelix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Starting dose of 240 mg (40 mg/mL) at Visit 2 followed by 6 maintenance doses of 80 mg (20 mg/mL) at monthly intervals (240/80 mg dose regimen), administered using IM injection.

    Number of subjects in period 1 [1]
    		Standard SC injection Optimised SC injection IM injection
    Started
    31
    27
    61
    Completed
    27
    22
    55
    Not completed
    4
    5
    6
         Consent withdrawn by subject
    1
    -
    -
         other reasons
    -
    2
    2
         Adverse event, non-fatal
    1
    -
    1
         Protocol deviation
    1
    3
    2
         Lack of efficacy
    1
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics were reported for subjects in the Full analysis set (FAS). All randomised and dosed subjects with at least one assessment of injection site pain after treatment initiation comprised the FAS. Overall, 120 subjects were randomised (Intention-to-Treat analysis set) but only 119 subjects were dosed as one subject withdrew from the trial and did not receive IMP.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard SC injection
    Reporting group description
    		 -

    Reporting group title
    Optimised SC injection
    Reporting group description
    		 -

    Reporting group title
    IM injection
    Reporting group description
    		 -

    Reporting group values
    		 Standard SC injection Optimised SC injection IM injection Total
    Number of subjects
    		 31 27 61 119
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.7 ( 7.65 ) 76.7 ( 7.08 ) 73.7 ( 8.50 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0
        Male
    		 31 27 61 119
    Stage of prostate cancer at time of diagnosis
    Units: Subjects
        Localised
    		 8 8 18 34
        Locally advanced
    		 7 5 17 29
        Metastatic
    		 8 3 4 15
        Not classifiable
    		 8 11 22 41
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised and dosed subjects with at least one assessment of injection site pain after treatment initiation comprised the Full Analysis Set (FAS). All analyses were performed based on the planned (randomised) treatment.

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    119
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    74.1 ( 8.05 )
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    119
    Stage of prostate cancer at time of diagnosis
    Units: Subjects
        Localised
    34
        Locally advanced
    29
        Metastatic
    15
        Not classifiable
    41

    End points

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    End points reporting groups
    Reporting group title
    Standard SC injection
    Reporting group description
    		 -

    Reporting group title
    Optimised SC injection
    Reporting group description
    		 -

    Reporting group title
    IM injection
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised and dosed subjects with at least one assessment of injection site pain after treatment initiation comprised the Full Analysis Set (FAS). All analyses were performed based on the planned (randomised) treatment.

    Primary: Difference in mean subject reported injection site pain score-Overall

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    End point title
    		 Difference in mean subject reported injection site pain score-Overall
    End point description
    Difference in the mean subject reported injection site pain scores measured on an ordinal scale ranging from 0 to 10 (0=no pain, 10=worst possible pain) between subjects receiving the optimised and standard SC injections, as well as between subjects receiving the IM and standard SC injections, over the duration of the trial.
    End point type
    Primary
    End point timeframe
    Period from starting dose to end of trial (EoT).
    End point values
    		 Standard SC injection Optimised SC injection IM injection
    Number of subjects analysed
    31
    27
    61
    Units: score on scale
        least squares mean (standard error)
    1.51 ( 0.13 )
    1.60 ( 0.14 )
    1.12 ( 0.09 )
    Statistical analysis title
    		 Optimised SC vs. standard SC injection
    Comparison groups
    Standard SC injection v Optimised SC injection
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8447
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.46
    Statistical analysis title
    		 IM injection vs. standard SC injection
    Comparison groups
    IM injection v Standard SC injection
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0228
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 -0.09

    Secondary: Subject reported injection site pain scores after degarelix starting dose

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    End point title
    		 Subject reported injection site pain scores after degarelix starting dose
    End point description
    Subject reported injection site pain scores (0=no pain, 10=worst possible pain) evaluated for degarelix SC injection techniques and degarelix IM injection after degarelix starting dose.
    End point type
    Secondary
    End point timeframe
    Pain scores collected 30 minutes after the injection and at bedtime for 7 days following the starting dose.
    End point values
    		 Standard SC injection Optimised SC injection IM injection
    Number of subjects analysed
    31
    26
    61
    Units: score on scale
        least squares mean (standard error)
    1.63 ( 0.23 )
    1.43 ( 0.26 )
    1.24 ( 0.17 )
    Statistical analysis title
    		 Optimised SC vs. standard SC injection
    Comparison groups
    Standard SC injection v Optimised SC injection
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5662
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.89
         upper limit
    		 0.49
    Statistical analysis title
    		 IM injection vs. standard SC injection
    Comparison groups
    IM injection v Standard SC injection
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1823
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 0.18

    Secondary: Subject reported injection site pain scores after degarelix maintenance dose

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    End point title
    		 Subject reported injection site pain scores after degarelix maintenance dose
    End point description
    Subject reported injection site pain scores (0=no pain, 10=worst possible pain) evaluated for degarelix SC injection techniques and degarelix IM injection after degarelix maintenance doses.
    End point type
    Secondary
    End point timeframe
    Pain scores collected from first maintenance dose until EoT.
    End point values
    		 Standard SC injection Optimised SC injection IM injection
    Number of subjects analysed
    29
    25
    61
    Units: score on the scale
        least squares mean (standard error)
    1.47 ( 0.14 )
    1.60 ( 0.15 )
    1.10 ( 0.10 )
    Statistical analysis title
    		 Optimised SC vs. standard SC injection
    Comparison groups
    Optimised SC injection v Standard SC injection
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5213
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 0.52
    Statistical analysis title
    		 IM injection vs. standard SC injection
    Comparison groups
    IM injection v Standard SC injection
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0253
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.69
         upper limit
    		 -0.05

    Secondary: Difference in mean change from pre-injection skin colour values at the injection site

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    End point title
    		 Difference in mean change from pre-injection skin colour values at the injection site
    End point description
    Difference in skin colour values (average of 4 measurements on skin redness [a*-axis: red-green; CIE L*a*b* system] at the injection site using DSM II ColorMeter) between pre- and post-injection for all injection techniques.
    End point type
    Secondary
    End point timeframe
    30 minutes and 2 days post-injection.
    End point values
    		 Standard SC injection Optimised SC injection IM injection
    Number of subjects analysed
    31
    27
    61
    Units: score on scale
    least squares mean (standard error)
        30 minutes post-injection
    1.71 ( 0.30 )
    1.32 ( 0.33 )
    1.14 ( 0.22 )
        2 days post-injection
    3.89 ( 0.39 )
    4.03 ( 0.43 )
    1.73 ( 0.28 )
    Statistical analysis title
    		 Optimised SC vs. standard SC injection (30 min)
    Comparison groups
    Optimised SC injection v Standard SC injection
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.378
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.26
         upper limit
    		 0.48
    Statistical analysis title
    		 IM injection vs. standard SC injection (30 min)
    Comparison groups
    IM injection v Standard SC injection
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1198
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.29
         upper limit
    		 0.15
    Statistical analysis title
    		 Optimised SC vs. standard SC injection (2 days)
    Comparison groups
    Optimised SC injection v Standard SC injection
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8134
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1.27
    Statistical analysis title
    		 IM injection vs. standard SC injection (2 days)
    Comparison groups
    IM injection v Standard SC injection
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.11
         upper limit
    		 -1.22

    Secondary: Estimated probability of a positive change of >1.5 units on redness scale after injection

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    End point title
    		 Estimated probability of a positive change of >1.5 units on redness scale after injection
    End point description
    Estimated probability of a positive change of more than 1.5 units on the redness scale after injection (measured by DSM II ColorMeter CIE L*a*b* system as a change in the a* axis).
    End point type
    Secondary
    End point timeframe
    30 minutes and 2 days post-injection.
    End point values
    		 Standard SC injection Optimised SC injection IM injection
    Number of subjects analysed
    31
    27 [1]
    61
    Units: estimated probability
    number (not applicable)
        30 minutes post-injecton
    52.5
    42.6
    34.2
        2 days post-injection
    77.4
    74.7
    42.8
    Notes
    [1] - N=27 analysed 30 minutes post-injection; N=26 analysed 2 days post-injection
    Statistical analysis title
    		 Optimised SC vs. standard SC injection (30 min)
    Comparison groups
    Optimised SC injection v Standard SC injection
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1231
    Method
    		 Regression, Logistic
    Parameter type
    		 Relative risk
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.05
    Statistical analysis title
    		 IM injection vs. standard SC injection (30 min)
    Comparison groups
    IM injection v Standard SC injection
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Logistic
    Parameter type
    		 Relative risk
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 0.87
    Statistical analysis title
    		 Optimised SC vs. standard SC injection (2 days)
    Statistical analysis description
    Number of subject included in analysis: N=57
    Comparison groups
    Optimised SC injection v Standard SC injection
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7389
    Method
    		 Regression, Logistic
    Parameter type
    		 Relative risk
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.21
    Statistical analysis title
    		 IM injection vs. standard SC injection (2 days)
    Comparison groups
    IM injection v Standard SC injection
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Relative risk
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 0.78

    Secondary: Treatment satisfaction of degarelix starting dose and maintenance doses

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    End point title
    		 Treatment satisfaction of degarelix starting dose and maintenance doses
    End point description
    Treatment satisfaction of degarelix starting dose and maintenance doses. Treatment satisfaction was measured on a scale from 1-7 (1=extremely satisfied and 7=extremely dissatisfied).
    End point type
    Secondary
    End point timeframe
    V=Visit; M=Month V2/M0/starting dose, V4/M1/maintenance dose 1, V6/M2/maintenance dose 2, V8/M3/maintenance dose 3, V9/M4/maintenance dose 4, V10/M5/maintenance dose 5, V11/M6/maintenance dose 6, EoT/last assessment for a subject.
    End point values
    		 Standard SC injection Optimised SC injection IM injection
    Number of subjects analysed
    31 [2]
    27 [3]
    61 [4]
    Units: subjects
        V2-Extremely satisfied
    7
    8
    11
        V2-Very satisfied
    9
    7
    23
        V2-Satisfied
    7
    7
    20
        V2-Somewhat satisfied
    1
    1
    3
        V2-Dissatisfied
    1
    0
    0
        V2-Very dissatisfied
    2
    0
    3
        V2-Extremely dissatisfied
    2
    1
    1
        V4-Extremely satisfied
    8
    7
    14
        V4-Very satisfied
    10
    6
    21
        V4-Satisfied
    7
    6
    13
        V4-Somewhat satisfied
    0
    1
    2
        V4-Dissatisfied
    1
    0
    2
        V4-Very dissatisfied
    1
    1
    4
        V4-Extremely dissatisfied
    1
    1
    2
        V6-Extremely satisfied
    10
    7
    18
        V6-Very satisfied
    8
    8
    21
        V6-Satisfied
    7
    7
    12
        V6-Somewhat satisfied
    0
    1
    2
        V6-Dissatisfied
    0
    0
    1
        V6-Very dissatisfied
    2
    0
    1
        V6-Extremely dissatisfied
    0
    0
    2
        V8-Extremely satisfied
    7
    3
    18
        V8-Very satisfied
    9
    10
    18
        V8-Satisfied
    5
    7
    15
        V8-Somewhat satisfied
    2
    1
    2
        V8-Dissatisfied
    0
    0
    0
        V8-Very dissatisfied
    2
    0
    1
        V8-Extremely dissatisfied
    0
    1
    2
        V9-Extremely satisfied
    10
    7
    17
        V9-Very satisfied
    11
    8
    19
        V9-Satisfied
    5
    5
    14
        V9-Somewhat satisfied
    0
    0
    0
        V9-Dissatisfied
    0
    1
    1
        V9-Very dissatisfied
    1
    0
    2
        V9-Extremely dissatisfied
    0
    0
    2
        V10-Extremely satisfied
    10
    9
    19
        V10-Very satisfied
    11
    6
    22
        V10-Satisfied
    5
    5
    9
        V10-Somewhat satisfied
    0
    0
    1
        V10-Dissatisfied
    0
    1
    0
        V10-Very dissatisfied
    1
    0
    0
        V10-Extremely dissatisfied
    0
    1
    1
        V11-Extremely satisfied
    13
    6
    22
        V11-Very satisfied
    7
    7
    20
        V11-Satisfied
    4
    3
    7
        V11-Somewhat satisfied
    0
    2
    2
        V11-Dissatisfied
    0
    0
    1
        V11-Very dissatisfied
    1
    1
    0
        V11-Extremely dissatisfied
    0
    1
    1
        EoT-Extremely satisfied
    14
    8
    25
        EoT-Very satisfied
    10
    7
    22
        EoT-Satisfied
    4
    4
    8
        EoT-Somewhat satisfied
    0
    2
    2
        EoT-Dissatisfied
    1
    1
    2
        EoT-Very dissatisfied
    1
    1
    0
        EoT-Extremely dissatisfied
    0
    2
    2
    Notes
    [2] - N=29 (V2), N=28 (V4), N=27 (V6, V9, V10), N=25 (V8, V11), N=30 (EoT)
    [3] - N=24 (V2), N=22 (V4, V8, V10), N=23 (V6), N=21 (V9), N=20 (V11), N=25 (EoT)
    [4] - N=61 (V2, EoT), N=58 (V4), N=57 (V6), N=56 (V8), N=55 (V9), N=52 (V10), N=53 (V11)
    No statistical analyses for this end point

    Secondary: Serum levels of testosterone in the IM treatment group

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    End point title
    		 Serum levels of testosterone in the IM treatment group [5]
    End point description
    Serum levels of testosterone at baseline, Month 1, Month 7, and EoT in the IM treatment group.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, Month 7, and EoT.
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point is specific to the IM treatment group.
    End point values
    		 IM injection
    Number of subjects analysed
    61 [6]
    Units: ng/mL
    median (full range (min-max))
        Baseline
    4.15 (1.38 to 7.23)
        Month 1
    0.12 (0.03 to 0.49)
        Month 7
    0.09 (0.01 to 0.26)
        EoT
    0.09 (0.01 to 0.26)
    Notes
    [6] - N=57 at baseline; N=59 at Month 1, N=54 at Month 7, N=60 at EoT/last assessment for a subject.
    No statistical analyses for this end point

    Secondary: Proportion of subjects with serum testosterone at castrate level (≤0.5 ng/mL) in the IM treatment group

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    End point title
    		 Proportion of subjects with serum testosterone at castrate level (≤0.5 ng/mL) in the IM treatment group [7]
    End point description
    Proportion of subjects with testosterone at castrate level (≤0.5 ng/mL) at Month 7 in the IM treatment group.
    End point type
    Secondary
    End point timeframe
    Month 7.
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point is specific to the IM treatment group.
    End point values
    		 IM injection
    Number of subjects analysed
    54
    Units: percent
        number (confidence interval 95%)
    100 (93.4 to 100.0)
    No statistical analyses for this end point

    Secondary: Frequency and severity of adverse events

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    End point title
    		 Frequency and severity of adverse events
    End point description
    Frequency and severity of adverse events.
    End point type
    Secondary
    End point timeframe
    From the time of obtaining informed consent until the last trial visit.
    End point values
    		 Standard SC injection Optimised SC injection IM injection
    Number of subjects analysed
    31
    27
    61
    Units: subjects
        Mild adverse events
    20
    14
    35
        Moderate adverse events
    10
    11
    23
        Severe adverse events
    3
    5
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of obtaining informed consent until the last trial visit.
    Adverse event reporting additional description
    Data is presented for the safety analysis set. The safety analysis set comprised all dosed subjects and was analysed according to the actual treatment received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Standard SC injection
    Reporting group description
    		 -

    Reporting group title
    Optimised SC injection
    Reporting group description
    		 -

    Reporting group title
    IM injection
    Reporting group description
    		 -

    Serious adverse events
    		 Standard SC injection Optimised SC injection IM injection
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 27 (14.81%)
    6 / 61 (9.84%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm prostate
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Chest injury
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Lung neoplasm surgery
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device failure
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Standard SC injection Optimised SC injection IM injection
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 31 (58.06%)
    18 / 27 (66.67%)
    41 / 61 (67.21%)
    Investigations
    Weight increased
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 27 (7.41%)
    3 / 61 (4.92%)
         occurrences all number
    0
    2
    3
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 27 (7.41%)
    2 / 61 (3.28%)
         occurrences all number
    1
    2
    2
    Vascular disorders
    Hot flush
         subjects affected / exposed
    10 / 31 (32.26%)
    9 / 27 (33.33%)
    22 / 61 (36.07%)
         occurrences all number
    10
    9
    24
    Flushing
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 27 (7.41%)
    1 / 61 (1.64%)
         occurrences all number
    0
    2
    1
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 27 (7.41%)
    9 / 61 (14.75%)
         occurrences all number
    0
    4
    10
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    7 / 31 (22.58%)
    11 / 27 (40.74%)
    19 / 61 (31.15%)
         occurrences all number
    20
    18
    40
    Injection site erythema
         subjects affected / exposed
    7 / 31 (22.58%)
    4 / 27 (14.81%)
    3 / 61 (4.92%)
         occurrences all number
    10
    8
    3
    Fatigue
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    6 / 61 (9.84%)
         occurrences all number
    2
    0
    6
    Pyrexia
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 27 (3.70%)
    4 / 61 (6.56%)
         occurrences all number
    1
    2
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 27 (3.70%)
    2 / 61 (3.28%)
         occurrences all number
    2
    1
    2
    Constipation
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 27 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    2
    0
    1
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    2 / 31 (6.45%)
    3 / 27 (11.11%)
    3 / 61 (4.92%)
         occurrences all number
    2
    3
    3
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    5 / 61 (8.20%)
         occurrences all number
    1
    0
    6
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    3 / 31 (9.68%)
    3 / 27 (11.11%)
    8 / 61 (13.11%)
         occurrences all number
    3
    4
    11
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 27 (3.70%)
    5 / 61 (8.20%)
         occurrences all number
    1
    1
    5
    Arthralgia
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 27 (7.41%)
    2 / 61 (3.28%)
         occurrences all number
    1
    2
    2
    Myalgia
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 27 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    4
    0
    2
    Bone pain
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 27 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    3
    0
    0
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 27 (0.00%)
    3 / 61 (4.92%)
         occurrences all number
    3
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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