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    Clinical Trial Results:
    An open label, one-arm, multiple dose study in patients with prostate cancer to demonstrate efficacy of a one month goserelin 3.6 mg implant in a two months treatment (2 application periods) and PK/PD analysis of Zoladex® 3.6 mg implant in additional 12 patients.

    Summary
    EudraCT number
    		 2011-001193-26
    Trial protocol
    		 DE   CZ   PL  
    Global end of trial date
    15 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jul 2016
    First version publication date
    30 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C_30050_P3_02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Acino Supply AG
    Sponsor organisation address
    Pfeffingerring 205, Aesch, Switzerland,
    Public contact
    Ulrike Seminati (Head of Corporate Communications), Acino International AG, Thurgauerstrasse 36/38, Zürich, Switzerland, +41 44 555 22 00,
    Scientific contact
    Sébastien Geneve (Head of Global Medical Affairs, Regulatory Affairs and Pharmacovigilance), Acino International AG, Thurgauerstrasse 36/38, Zürich, Switzerland, +41 44 555 22 00,
    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
    06 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Mar 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate that Acino Goserelin 3.6 mg implant is effective in achieving and maintaining castration levels of testosterone.
    Protection of trial subjects
    Patients could be hospitalized for 2 or more days at the beginning of the study (first implantation of study medication at Day 0), if required, or if more convenient for the patient. An independent Medical Monitor was implemented to evaluate the safety of the patients on an ongoing basis.
    Background therapy
    		 -
    Evidence for comparator
    		 A small comparator group receiving Zoladex 3.6 mg implant was used to compare pharmacokinetic and pharmacodynamic data of Acino Goserelin with a marketed and well established reference product.
    Actual start date of recruitment
    11 Sep 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 26
    Country: Number of subjects enrolled
    Czech Republic: 14
    Country: Number of subjects enrolled
    Germany: 44
    Worldwide total number of subjects
    84
    EEA total number of subjects
    84
    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)
    12
    From 65 to 84 years
    69
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were enrolled from 11-Sep-2012 to 07-Feb-2013 at 10 sites in 3 countries.

    Pre-assignment
    Screening details
    		 Screening was conducted up to 2 weeks prior to injection of the first implant. 96 patients were screened; 84 patients were randomized.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Acino Goserelin
    Arm description
    		 Patients received Acino Goserelin 3.6 mg implant at Day 0 and Day 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Acino Goserelin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Implantation
    Dosage and administration details
    Patients received Acino Goserelin 3.6 mg implant subcutaneously with a special applicator at Days 0 and Day 28. During administration a second staff person had to be present to confirm that the administration was done correctly.

    Arm title
    		 Zoladex
    Arm description
    		 Patients received Zoladex 3.6 mg implant at Day 0 and Day 28.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Zoladex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Implantation
    Dosage and administration details
    Patients received Zoladex 3.6 mg implants subcutaneously with a special applicator at Day 0 and Day 28. During administration a second staff person had to be present to confirm that the administration was done correctly.

    Number of subjects in period 1
    		Acino Goserelin Zoladex
    Started
    76
    8
    Completed
    53
    8
    Not completed
    23
    0
         Study was set on hold.
    23
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 84 84
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 69 69
        85 years and over
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 84 84

    End points

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    End points reporting groups
    Reporting group title
    Acino Goserelin
    Reporting group description
    		 Patients received Acino Goserelin 3.6 mg implant at Day 0 and Day 28.

    Reporting group title
    Zoladex
    Reporting group description
    		 Patients received Zoladex 3.6 mg implant at Day 0 and Day 28.

    Subject analysis set title
    FAS - Acino Goserelin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS: N = 61) included all randomized patients to whom at least 1 implant had succesfully been administered. Patients who prematurely discontinued the study due to the study being on hold were excluded. Patients of the FAS who received the Acino Goserelin implant (N = 53) are defined as FAS - Acino Goserelin.

    Subject analysis set title
    PK/PD analysis set - Acino Goserelin
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All patients of the FAS who receiced Acino-Goserelin and had at least one post-baseline pharmacokinetic/pharmacodynamic (PK/PD) measurement (N = 53). Patients who early discontinued the study because the study was set on hold were excluded.

    Subject analysis set title
    PK/PD analysis set - Zoladex
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All patients of the FAS who received Zoladex and had at least one post-baseline PK/PD measurement (N = 8). Patients who early discontinued the study because the study was set on hold were excluded.

    Primary: Testosterone response rate at and after Day 28 until Day 56

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    End point title
    		 Testosterone response rate at and after Day 28 until Day 56 [1]
    End point description
    Testosterone response rate was defined as the rate of patients with testosterone values sustained below castration level (0.5 ng/mL) at and after Day 28 until Day 56.
    End point type
    Primary
    End point timeframe
    Day 28 to Day 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: The primary endpoint, testosterone response rate, was evaluated using exact 95% confidence intervals (CI) according to Clopper-Pearson. The study objective was to show that the lower bound of this confidence interval was >90%.
    End point values
    		 FAS - Acino Goserelin
    Number of subjects analysed
    53
    Units: percent
        number (confidence interval 95%)
    92.5 (81.8 to 97.9)
    No statistical analyses for this end point

    Secondary: Percentage of patients who reached castration level of testosterone (< 0.5 ng/mL) at the last visit (Day 56)

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    End point title
    		 Percentage of patients who reached castration level of testosterone (< 0.5 ng/mL) at the last visit (Day 56)
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 56
    End point values
    		 FAS - Acino Goserelin
    Number of subjects analysed
    53
    Units: percent
        number (confidence interval 95%)
    98.1 (89.9 to 100)
    No statistical analyses for this end point

    Secondary: Time after first implantation until castration level of testosterone (< 0.5 ng/mL) was achieved for the first time

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    End point title
    		 Time after first implantation until castration level of testosterone (< 0.5 ng/mL) was achieved for the first time
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 56
    End point values
    		 FAS - Acino Goserelin
    Number of subjects analysed
    52
    Units: Days
        median (full range (min-max))
    21 (14 to 35)
    No statistical analyses for this end point

    Secondary: Rate of patients with testosterone values sustained below 0.2 ng/mL at and after Day 28 until Day 56

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    End point title
    		 Rate of patients with testosterone values sustained below 0.2 ng/mL at and after Day 28 until Day 56
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28 to Day 56
    End point values
    		 FAS - Acino Goserelin
    Number of subjects analysed
    53
    Units: percent
        number (confidence interval 95%)
    54.7 (40.4 to 68.4)
    No statistical analyses for this end point

    Secondary: Results of clinical examination of the prostate

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    End point title
    		 Results of clinical examination of the prostate
    End point description
    The prostate was examined by the investigator via a digital rectal examination and classified according to the categories listed below.
    End point type
    Secondary
    End point timeframe
    At Day 56
    End point values
    		 FAS - Acino Goserelin
    Number of subjects analysed
    53
    Units: percent
    number (not applicable)
        Normal
    20.8
        Hard
    34
        Hard, Asymmetrical
    9.4
        Hard, Asymmetrical, Enlarged
    15.1
        Hard, Enlarged
    3.8
        Enlarged
    13.2
        Asymmetrical, Enlarged
    3.8
        Missing
    0
    No statistical analyses for this end point

    Secondary: Prostate specific antigen (PSA) levels

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    End point title
    		 Prostate specific antigen (PSA) levels
    End point description
    End point type
    Secondary
    End point timeframe
    Time course from Day 0 to Day 56
    End point values
    		 FAS - Acino Goserelin
    Number of subjects analysed
    53
    Units: µg/L
    median (full range (min-max))
        Day 0
    7.4 (0.1 to 2735.2)
        Day 28
    3.1 (0.1 to 822.2)
        Day 31
    2.4 (0.1 to 722.2)
        Day 35
    2.3 (0.1 to 610.5)
        Day 42
    2 (0.1 to 497.2)
        Day 49
    1.3 (0.1 to 417.3)
        Day 56
    0.9 (0.1 to 396.5)
    No statistical analyses for this end point

    Secondary: PK - Goserelin concentration

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    End point title
    		 PK - Goserelin concentration
    End point description
    End point type
    Secondary
    End point timeframe
    Time course from Day 0 to Day 56
    End point values
    		 PK/PD analysis set - Acino Goserelin PK/PD analysis set - Zoladex
    Number of subjects analysed
    53
    8
    Units: ng/mL
    median (full range (min-max))
        Day 0
    0 (0 to 0)
    0 (0 to 0)
        Day 1
    0.71 (0 to 2)
    0.36 (0.2 to 0.55)
        Day 2
    0.43 (0 to 0.89)
    0.31 (0.17 to 0.48)
        Day 4
    0.23 (0 to 0.48)
    0.17 (0.1 to 0.24)
        Day 7
    0.37 (0 to 0.95)
    0.1 (0.1 to 0.12)
        Day 14
    0.59 (0 to 3.45)
    1.19 (0.25 to 2.83)
        Day 21
    0.51 (0 to 1.09)
    0.44 (0.29 to 0.86)
        Day 28
    0.25 (0 to 0.87)
    0.21 (0.14 to 0.48)
        Day 31
    0.46 (0 to 1.12)
    0.3 (0.21 to 0.65)
        Day 35
    0.47 (0 to 1.38)
    0.21 (0.1 to 0.95)
        Day 42
    0.61 (0 to 1.61)
    0.8 (0.1 to 4.62)
        Day 49
    0.53 (0 to 1.38)
    0.43 (0.14 to 0.86)
        Day 56
    0.25 (0 to 0.75)
    0.18 (0.1 to 0.74)
    No statistical analyses for this end point

    Secondary: PD - Plasma levels of luteinizing hormone (LH) between Day 0 and Day 56

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    End point title
    		 PD - Plasma levels of luteinizing hormone (LH) between Day 0 and Day 56
    End point description
    End point type
    Secondary
    End point timeframe
    Time course from Day 0 to Day 56
    End point values
    		 PK/PD analysis set - Acino Goserelin PK/PD analysis set - Zoladex
    Number of subjects analysed
    53
    8
    Units: IU/L
    median (full range (min-max))
        Day 0
    6.5 (1.1 to 37.3)
    8.3 (2.9 to 16.5)
        Day 1
    36.4 (6.6 to 124.4)
    30.9 (17.5 to 55.2)
        Day 2
    21.4 (5.9 to 58.2)
    18.1 (12.1 to 28.4)
        Day 4
    14 (4 to 39.5)
    17 (7.2 to 25.2)
        Day 7
    9.3 (2.7 to 28.9)
    8.8 (4.8 to 12.4)
        Day 14
    3.4 (1.1 to 10.8)
    4.3 (1.9 to 5.2)
        Day 21
    1.4 (0.4 to 5.1)
    1.45 (0.8 to 2)
        Day 28
    0.5 (0.1 to 2.7)
    0.6 (0.2 to 0.9)
        Day 31
    0.4 (0.1 to 3.3)
    0.4 (0.1 to 0.7)
        Day 35
    0.3 (0.1 to 5.5)
    0.2 (0.1 to 0.4)
        Day 42
    0.1 (0.1 to 4.3)
    0.1 (0.1 to 0.4)
        Day 49
    0.1 (0.1 to 5.2)
    0.1 (0.1 to 0.2)
        Day 56
    0.1 (0.1 to 5.6)
    0.1 (0.1 to 0.1)
    No statistical analyses for this end point

    Secondary: PD - Plasma levels of follicle stimulating hormone (FSH) between Day and Day 56

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    End point title
    		 PD - Plasma levels of follicle stimulating hormone (FSH) between Day and Day 56
    End point description
    End point type
    Secondary
    End point timeframe
    Time course from Day 0 to Day 56
    End point values
    		 PK/PD analysis set - Acino Goserelin PK/PD analysis set - Zoladex
    Number of subjects analysed
    53
    8
    Units: IU/L
    median (full range (min-max))
        Day 0
    9.5 (1.7 to 49.3)
    9.5 (5 to 27.8)
        Day 1
    24.1 (4.8 to 104.6)
    19.8 (10.3 to 55.8)
        Day 2
    15 (3.3 to 59.5)
    13.3 (7.7 to 31.2)
        Day 4
    9.4 (2.1 to 44.3)
    8.3 (5.8 to 17.9)
        Day 7
    4.8 (1.1 to 25.3)
    4.1 (2.2 to 10.9)
        Day 14
    2.9 (0.8 to 11.7)
    2.7 (1.4 to 4.4)
        Day 21
    2.7 (0.9 to 7.3)
    2.2 (1 to 4.3)
        Day 28
    3.4 (0.9 to 7.8)
    2.7 (1.1 to 5.8)
        Day 31
    3.2 (1 to 7.7)
    2.7 (1 to 5)
        Day 35
    3.6 (0.9 to 9.6)
    3.7 (1.5 to 5.7)
        Day 42
    3.3 (0.6 to 10.6)
    3.4 (1.2 to 5.9)
        Day 49
    3.8 (0.9 to 11.7)
    3.3 (1 to 6.9)
        Day 56
    4.2 (0.6 to 13.7)
    4.4 (1.2 to 6.4)
    No statistical analyses for this end point

    Secondary: Time course of testosterone levels on Day 28, 31, 35, 42, 49, and 56

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    End point title
    		 Time course of testosterone levels on Day 28, 31, 35, 42, 49, and 56
    End point description
    End point type
    Secondary
    End point timeframe
    On Days 28, 31, 35, 42, 49, and 56
    End point values
    		 PK/PD analysis set - Acino Goserelin PK/PD analysis set - Zoladex
    Number of subjects analysed
    53
    8
    Units: ng/mL
    median (full range (min-max))
        Day 28
    0.19 (0.1 to 2.24)
    0.13 (0.1 to 0.33)
        Day 31
    0.15 (0.1 to 2.68)
    0.11 (0.1 to 0.2)
        Day 35
    0.11 (0.1 to 2.07)
    0.1 (0.1 to 0.19)
        Day 42
    0.11 (0.1 to 3.23)
    0.1 (0.1 to 0.16)
        Day 49
    0.1 (0.1 to 2.37)
    0.1 (0.1 to 0.21)
        Day 56
    0.1 (0.1 to 3.01)
    0.1 (0.1 to 0.19)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were documented starting at Screening until study Day 56. Serious adverse events still ongoing at Day 56 were followed-up after the end of the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Acino Goserelin
    Reporting group description
    		 Patients received Acino Goserelin 3.6 mg implant on Day 0 and Day 28.

    Reporting group title
    Zoladex
    Reporting group description
    		 Patients received Zoladex 3.6 mg implant on Day 0 and Day 28.

    Serious adverse events
    		 Acino Goserelin Zoladex
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 76 (3.95%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Arrhythmia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Acino Goserelin Zoladex
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 76 (44.74%)
    4 / 8 (50.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to bone
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 76 (2.63%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Hot flush
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 76 (17.11%)
    3 / 8 (37.50%)
         occurrences all number
    13
    3
    Hypertension
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 76 (5.26%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0
    General disorders and administration site conditions
    Asthenia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 76 (3.95%)
    1 / 8 (12.50%)
         occurrences all number
    4
    2
    Implant site pruritus
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 76 (2.63%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Influenza like illness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Injection site haematoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 76 (2.63%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Vessel puncture site haematoma
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Gynaecomastia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Depression
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Insomnia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Aspartate aminotransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Blood follicle stimulating hormone increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Blood luteinising hormone decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Blood luteinising hormone increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 76 (2.63%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Contusion
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 76 (2.63%)
    1 / 8 (12.50%)
         occurrences all number
    2
    1
    Cardiac disorders
    Atrioventricular block first degree
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Burning sensation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Dizziness
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Hyperaesthesia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Tension headache
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Melaena
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Pruritus
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Urethral stenosis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Urinary retention
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Bone pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal discomfort
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Pain in extremity
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 76 (3.95%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    Rhabdomyolysis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Cystitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 76 (3.95%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    Rhinitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypocalcaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Feb 2012
    This amendment stated that only the testosterone values at Screening (and not Baseline) would be used to decide if a patient was eligible for participation in the study, as it was assumed that testosterone values would not change from Screening to Baseline (maximum of 2 weeks).
    04 Feb 2013
    This amendment - changed the planned number of recruited patients from 130 to 145 because it was considered that the percentage of patients expected to be excluded from the analysis is rather 10% than 4% as initially assumed; - changed the definitions of analysis populations and primary analysis set from the per protocol to the full analysis set; - included some clarifications and editorial changes;
    20 Jun 2013
    This amendment - specified an interim analysis of the primary efficacy endpoint and the main safety data due to an unconfirmed out-of-specification (OOS) result for the Acino implant that was noticed during stability testing. Further investigations showed that the non-confirmed OOS-result was not related to the analytical procedure, the manufacturing process, or to the product an its quality. Nevertheless, an interim analysis was to provide a risk/benefit assessment whether to stop the study due to futility or continue the study without changes; - included some clarifications and editorial changes;
    06 Oct 2014
    - Androgen deprivation therapy was added to exclusion criteria (i.e. treatment with gonadotropin releasing hormone (GnRH) analogs, treatment with antiandrogens or androgen receptor blockers within 3 months before baseline was not allowed); - A number of exclusion criteria were changed in accordance with scientific advices from FDA for a similar study;
    06 May 2015
    A statement regarding the study medication administration was added that administration was to be supervised by a further person, who confirmed a correct administration in the Case Report Form as well as in the patient file. It also added that the blood samples taken for goserelin levels would be analyzed shortly after implantation of study medication to ensure that the study medication administration was successful.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    15 Jul 2015
    The study C_30050_P3_02 was on hold since 08 February 2013 due to an unconfirmed out-of-specification result of Acino Goserelin that was noticed during stability testing. A not pre-planned interim analysis by an independant Data Monitoring Committee, and additional testing justified the conclusion that the benfit/risk ratio in case of study re-start remained positive. Nevertheless, due to a change in the portfolio strategy of the sponsor Acino it was decided not to pursue the Goserelin study C_30050_P3_02.
    -

    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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