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    Clinical Trial Results:
    The effect of testosterone replacement in patients with hypogonadotroph hypogonadism due to opioid treatment for non-malignant disease A double-blinded, randomized and placebo-controlled trial

    Summary
    EudraCT number
    		 2014-004729-42
    Trial protocol
    		 DK  
    Global end of trial date
    04 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Nov 2020
    First version publication date
    26 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    22102014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02433730
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    kløvervænget 6, Odense, Denmark, 5000
    Public contact
    Department of endocrinology, Odense University Hospital, department of endocrinology, +45 65412502, MSA@rsyd.dk
    Scientific contact
    Marianne Andersen, Odense University Hospital, department of endocrinology, +45 65412502, MSA@rsyd.dk
    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
    01 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of testosterone replacement therapy in men with OPIAD on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2015
    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
    Denmark: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    41
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Deltagere inviteres fra smerteklinikken OUH

    Pre-assignment
    Screening details
    		 lægelig vurdering

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Testosterone
    Arm description
    		 Modtager Nebido i 6 mdr
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nebido
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled injector
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1000 mg intramuscular injection

    Arm title
    		 Placebo
    Arm description
    		 injektions with placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4ml intramuscular injection

    Number of subjects in period 1
    		Testosterone Placebo
    Started
    20
    21
    Completed
    18
    20
    Not completed
    2
    1
         Adverse event, non-fatal
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Testosterone
    Reporting group description
    		 Modtager Nebido i 6 mdr

    Reporting group title
    Placebo
    Reporting group description
    		 injektions with placebo

    Reporting group values
    		 Testosterone Placebo Total
    Number of subjects
    		 20 21 41
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 20 21 41
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 20 21 41

    End points

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    End points reporting groups
    Reporting group title
    Testosterone
    Reporting group description
    		 Modtager Nebido i 6 mdr

    Reporting group title
    Placebo
    Reporting group description
    		 injektions with placebo

    Primary: muscle mass

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    End point title
    		 muscle mass
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Testosterone Placebo
    Number of subjects analysed
    20
    20
    Units: kilo units
        median (inter-quartile range (Q1-Q3))
    60.4 (53.7 to 66.3)
    58.6 (53.9 to 63.7)
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Testosterone v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: weight

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    End point title
    		 weight
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Testosterone Placebo
    Number of subjects analysed
    18
    21
    Units: kg
        median (inter-quartile range (Q1-Q3))
    97.6 (88.6 to 107.8)
    100.9 (87.8 to 112.2)
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Testosterone v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within 24 h
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 -

    Reporting group title
    testosterone
    Reporting group description
    		 -

    Serious adverse events
    		 placebo testosterone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 placebo testosterone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 20 (10.00%)
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32213659
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    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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