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    Clinical Trial Results:
    A Phase II, Open Label, Active Control, Multi-National, Multi-Centre, Randomized, Parallel Group Study Assessing Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of CAM2032 q1m (Leuprolide Acetate FluidCrystal® Injection Depot once monthly) after Repeat Doses of 3.75 mg and 7.5 mg of Leuprolide Acetate vs. Eligard® 7.5 mg in Patients with Prostate Cancer

    Summary
    EudraCT number
    		 2014-001074-34
    Trial protocol
    		 FI   HU  
    Global end of trial date
    10 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Nov 2016
    First version publication date
    25 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HS-12-460
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02212197
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Camurus AB
    Sponsor organisation address
    Ideon Science Park, Gamma Building, Sölvegatan 41, Sweden, SE-223 70 Lund
    Public contact
    Director, Clinical Programme Management, Camurus AB, +46 46286 3852, Hakan.Olsson@camurus.com
    Scientific contact
    CRA, TFS, +358 4450 6 6323, heidi.oksama@tfscro.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
    10 Nov 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the pharmacokinetic (PK) profiles after repeated administration of CAM2032 at doses of 3.75 mg and 7.5 mg leuprolide acetate, in patients with prostate cancer.
    Protection of trial subjects
    The trial was conducted in compliance with the approved clinical trial protocol and its amendments, regulatory requirements, Good Clinical Practice and the ethical principles of the latest revision of the Declaration of Helsinki as adopted by the World Medical Association.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Sep 2014
    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: 31
    Country: Number of subjects enrolled
    Hungary: 20
    Worldwide total number of subjects
    51
    EEA total number of subjects
    51
    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)
    9
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 57 participants were screened, out of which 51 participants were randomized and treated in this trial, which was conducted at 7 trial sites (4 in Finland and 3 in Hungary).

    Pre-assignment
    Screening details
    		 Participants were screened within 14 days of first dose of trial drug and eligible participants enrolled.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This trial was an open-label trial. The randomization was used to assign the participants to one of the three treatment groups.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CAM2032 3.75 mg
    Arm description
    		 Participants were administered single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CAM2032 3.75 mg
    Investigational medicinal product code
    Other name
    Leuprolide Acetate FluidCrystal® Injection Depot
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.

    Arm title
    		 CAM2032 7.5 mg
    Arm description
    		 Participants were administered single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CAM2032 7.5 mg
    Investigational medicinal product code
    Other name
    Leuprolide Acetate FluidCrystal® Injection Depot
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.

    Arm title
    		 Eligard 7.5 mg
    Arm description
    		 Participants were administered single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Eligard 7.5 mg
    Investigational medicinal product code
    Other name
    Leuprolide acetate
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were administered single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.

    Number of subjects in period 1
    		CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Started
    19
    15
    17
    Completed
    18
    15
    17
    Not completed
    1
    0
    0
         Due to need for radiotherapy
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CAM2032 3.75 mg
    Reporting group description
    		 Participants were administered single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.

    Reporting group title
    CAM2032 7.5 mg
    Reporting group description
    		 Participants were administered single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.

    Reporting group title
    Eligard 7.5 mg
    Reporting group description
    		 Participants were administered single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.

    Reporting group values
    		 CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg Total
    Number of subjects
    		 19 15 17 51
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 6 1 2 9
        From 65-84 years
    		 13 14 15 42
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.7 ( 9.5 ) 71.9 ( 6.3 ) 70.9 ( 7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0
        Male
    		 19 15 17 51

    End points

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    End points reporting groups
    Reporting group title
    CAM2032 3.75 mg
    Reporting group description
    		 Participants were administered single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.

    Reporting group title
    CAM2032 7.5 mg
    Reporting group description
    		 Participants were administered single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.

    Reporting group title
    Eligard 7.5 mg
    Reporting group description
    		 Participants were administered single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.

    Subject analysis set title
    CAM2032/Eligard
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per-protocol Set consisted of all randomized participants in the safety population who had a complete PK profile.

    Primary: Observed maximum serum concentration (Cmax) for Dose 1 and Dose 3

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    End point title
    		 Observed maximum serum concentration (Cmax) for Dose 1 and Dose 3 [1]
    End point description
    Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal products (IMPs).
    End point type
    Primary
    End point timeframe
    Days 0 and 56
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistical analysis was done for this primary endpoint.
    End point values
    		 CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Number of subjects analysed
    15
    15
    17
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Dose 1 (n= 15, 15, 17)
    6.14 ( 41.1 )
    9.66 ( 31.5 )
    13.6 ( 54.7 )
        Dose 3 (n= 15, 15, 17)
    5.36 ( 33.3 )
    11.3 ( 36.8 )
    12.1 ( 47.3 )
    No statistical analyses for this end point

    Primary: Apparent terminal half-life (t1/2) for Dose 1 and Dose 3

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    End point title
    		 Apparent terminal half-life (t1/2) for Dose 1 and Dose 3 [2]
    End point description
    Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMPs.
    End point type
    Primary
    End point timeframe
    Days 0 and 56
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistical analysis was done for this primary endpoint.
    End point values
    		 CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Number of subjects analysed
    15
    15
    17
    Units: hour
    arithmetic mean (standard deviation)
        Dose 1 (n= 14, 14, 9)
    205 ( 113 )
    231 ( 142 )
    743 ( 1677 )
        Dose 3 (n= 11, 11, 15)
    299 ( 277 )
    434 ( 867 )
    378 ( 570 )
    No statistical analyses for this end point

    Primary: Area under the serum concentration-time curve (AUC), computed using the linear/log trapezoidal rule, linear up to Cmax and thereafter log transformed concentration over the dosing interval (tau = 28 days) (AUCtau) for Dose 1 and Dose 3

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    End point title
    		 Area under the serum concentration-time curve (AUC), computed using the linear/log trapezoidal rule, linear up to Cmax and thereafter log transformed concentration over the dosing interval (tau = 28 days) (AUCtau) for Dose 1 and Dose 3 [3]
    End point description
    Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMPs.
    End point type
    Primary
    End point timeframe
    Days 0 and 56
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistical analysis was done for this primary endpoint.
    End point values
    		 CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Number of subjects analysed
    15
    15
    17
    Units: h*ng/mL
    geometric mean (geometric coefficient of variation)
        Dose 1 (n= 15, 15, 17)
    329 ( 37.6 )
    622 ( 45.2 )
    397 ( 45.3 )
        Dose 3 (n= 15, 15, 17)
    343 ( 24.7 )
    757 ( 53.4 )
    460 ( 62.2 )
    No statistical analyses for this end point

    Secondary: Relative bioavailability of leuprolide following injections of the IMP for Dose 3

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    End point title
    		 Relative bioavailability of leuprolide following injections of the IMP for Dose 3
    End point description
    Dose adjusted AUCtau values after Dose 3 were compared for CAM2032 and Eligard in the evaluation of relative bioavailability. The dose adjusted AUCtau values of CAM2032 3.75 mg and CAM2032 7.5 mg were merged in the comparison with Eligard. ANOVA of log transformed AUCtau adjusted for nominal dose, including treatment group and country as factors. The measure type number defined below is the ratio of relative bioavailability of leuprolide for CAM2032 vs Eligard.
    End point type
    Secondary
    End point timeframe
    Day 56
    End point values
    		 CAM2032/Eligard
    Number of subjects analysed
    47
    Units: percentage
        number (confidence interval 90%)
    1.5 (1.19 to 1.9)
    No statistical analyses for this end point

    Secondary: Profiles of testosterone concentration (ng/dL) following injections of the IMP

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    End point title
    		 Profiles of testosterone concentration (ng/dL) following injections of the IMP
    End point description
    The Pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126/early termination (ET).
    End point type
    Secondary
    End point timeframe
    Days 0 to 126/ET
    End point values
    		 CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Number of subjects analysed
    15
    15
    17
    Units: ng/dL
    median (inter-quartile range (Q1-Q3))
        Day 0 (predose) (n= 15, 15, 17)
    443 (369 to 546)
    321 (269 to 439)
    350 (240 to 465)
        Day 28 (predose) (n= 15, 15, 17)
    20.9 (18.3 to 47)
    24.5 (16.1 to 210)
    18.1 (11.1 to 28.1)
        Day 56 (predose) (n= 15, 15, 17)
    14.6 (10.7 to 19.3)
    13.8 (7.8 to 22)
    12 (9.29 to 15)
        Day 84 (n= 15, 15, 17)
    14.8 (9.17 to 27.6)
    10.6 (7.5 to 18.8)
    12.4 (9.92 to 13.8)
        Day 126 (n= 15, 15, 17)
    423 (258 to 526)
    278 (124 to 470)
    85.8 (16 to 280)
    No statistical analyses for this end point

    Secondary: Time (days) to Testosterone Recovery after Dose 3

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    End point title
    		 Time (days) to Testosterone Recovery after Dose 3
    End point description
    The PD effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last injection of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126/ET.
    End point type
    Secondary
    End point timeframe
    Day 56
    End point values
    		 CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Number of subjects analysed
    15
    15
    17
    Units: days
        arithmetic mean (standard deviation)
    46.2 ( 13.6 )
    52.3 ( 20.6 )
    65 ( 5.7 )
    No statistical analyses for this end point

    Secondary: Mean Prostate Specific Antigen (PSA) Concentration

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    End point title
    		 Mean Prostate Specific Antigen (PSA) Concentration
    End point description
    The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126/ET.
    End point type
    Secondary
    End point timeframe
    Days 0 to 126/ET
    End point values
    		 CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Number of subjects analysed
    15
    15
    17
    Units: ng/mL
    median (inter-quartile range (Q1-Q3))
        Day 0 (predose) (n= 15, 15, 17)
    14.9 (5.8 to 85.4)
    18.8 (9.6 to 93.5)
    14.6 (4.7 to 32.9)
        Day 28 (predose) (n= 15, 15, 17)
    9 (2.8 to 19)
    8.3 (5.9 to 31.5)
    4.6 (2.3 to 8)
        Day 56 (predose) (n= 15, 15, 17)
    3.6 (1.1 to 8.4)
    5.8 (1.1 to 11.2)
    2.1 (0.8 to 4.1)
        Day 84 (n= 15, 15, 17)
    2.3 (1.1 to 5.6)
    2.6 (0.8 to 14)
    1.6 (0.4 to 2.7)
        Day 126 (n= 15, 15, 17)
    4.7 (2.9 to 19.9)
    3.1 (1.5 to 19.1)
    1.6 (0.5 to 3.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants were carefully monitored for the occurrence of adverse events during the trial from Day 0 to the completion of the follow-up visit (Day 126/early termination), up to 18 weeks.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    CAM2032 3.75 mg
    Reporting group description
    		 Participants were administered single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.

    Reporting group title
    CAM2032 7.5 mg
    Reporting group description
    		 Participants were administered single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.

    Reporting group title
    Eligard 7.5 mg
    Reporting group description
    		 Participants were administered single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.

    Serious adverse events
    		 CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (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
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (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
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 19 (73.68%)
    12 / 15 (80.00%)
    10 / 17 (58.82%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    8 / 19 (42.11%)
    4 / 15 (26.67%)
    5 / 17 (29.41%)
         occurrences all number
    8
    4
    5
    Hypertension
         subjects affected / exposed
    3 / 19 (15.79%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    3
    1
    0
    Haematoma
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    0
    3
    Injection site erythema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    Fatigue
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Injection site nodule
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Prostatic pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Genital pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    0
    2
    Depressed mood
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Blood urine
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 19 (15.79%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    3
    0
    1
    Ligament sprain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle strain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Arrhythmia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    3 / 17 (17.65%)
         occurrences all number
    0
    2
    6
    Sciatica
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Syncope
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 19 (21.05%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    5
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Inguinal hernia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    1
    0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 15 (13.33%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    2
    Haematuria
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    1
    0
    Nocturia
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 15 (13.33%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    Haemorrhage urinary tract
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Micturition urgency
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Bladder pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Incontinence
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Urethral pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 15 (20.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    4
    1
    Pain in extremity
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 15 (6.67%)
    2 / 17 (11.76%)
         occurrences all number
    1
    1
    2
    Musculoskeletal pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    2
    0
    1
    Arthralgia
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 15 (13.33%)
    1 / 17 (5.88%)
         occurrences all number
    0
    2
    1
    Muscle spasms
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    1
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Neck pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Bone pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Bursitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Groin pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    3 / 19 (15.79%)
    3 / 15 (20.00%)
    1 / 17 (5.88%)
         occurrences all number
    6
    3
    1
    Abscess
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Localised infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jun 2014
    This amendment was prepared after request from the Hungarian Authorities to add the analysis of HbA1c. In addition, changes to sampling time points for testosterone and time windows for deviations from sampling times were made. Minor errors in the text were also corrected.
    26 Nov 2014
    This amendment was issued to clarify the visit window of ±1 day for the visits on Days 21, 49, 77, 84, 91, 98, 105, 112, 119, and 126, and to provide an updated instruction for the preparation of CAM2032 before administration (included in Appendix C in the clinical trial protocol).

    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.
    The endpoints 1) days of suppression of s-T below 50 ng/dL after repeated injection of the study medication and 2) percentage of patients with s-T control escapes after injection of study medication were not investigated.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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