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    Clinical Trial Results:
    Odense Androgen Study - The effect of Testim vs strength training i a populationbased, randomised, placebocontrolled, doubleblinded study in hypogonadal men

    Summary
    EudraCT number
    		 2007-001690-28
    Trial protocol
    		 DK  
    Global end of trial date
    20 Sep 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    22978379
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00700024
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    kløvervænget 6, Odense, Denmark,
    Public contact
    Department of Endocrinology, Odense University Hospital, department of Endocrinology, +45 65412502,
    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
    29 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Sep 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) The effect of Testosterone (testim) in a randomized doubleblinded plcebocontrolled study on body composition, liverfat and cardiovascular risk parameters 2) The Effect of training on body composition, liverfat and cardiovascular risk parameters 3)Compare the effect of testosterone and training on body composition, liverfat and cardiovascular risk parameters 4) Investigate the effect of training on the serum level of Testosterone
    Protection of trial subjects
    as requested by national authority
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Aug 2008
    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: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    40
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Men aged 60+, waist >94 cm and bioavailable testosterone < 7.3 nmol/L

    Pre-assignment
    Screening details
    		 Men aged 60+, waist >94 cm and bioavailable testosterone < 7.3 nmol/L

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Testosterone
    Arm description
    		 testim gel 5-10 g/dag
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Testim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    50-100 mg testosterone gel/dag

    Arm title
    		 Placebo
    Arm description
    		 PLacebo gel for 6 months
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    5-10 g gel/day

    Arm title
    		 Strengh training + testim
    Arm description
    		 strenth training for 6 months (+ testim for the last 3 months)
    Arm type
    		 training

    Investigational medicinal product name
    Testim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    50-100 mg testosterone gel/dag

    Arm title
    		 Strenght training + placebo
    Arm description
    		 Stength training for 6 months (+ placebo for the last 3 months)
    Arm type
    		 training

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    5-10 g gel/day

    Number of subjects in period 1
    		Testosterone Placebo Strengh training + testim Strenght training + placebo
    Started
    20
    20
    10
    10
    Completed
    20
    20
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Testosterone
    Reporting group description
    		 testim gel 5-10 g/dag

    Reporting group title
    Placebo
    Reporting group description
    		 PLacebo gel for 6 months

    Reporting group title
    Strengh training + testim
    Reporting group description
    		 strenth training for 6 months (+ testim for the last 3 months)

    Reporting group title
    Strenght training + placebo
    Reporting group description
    		 Stength training for 6 months (+ placebo for the last 3 months)

    Reporting group values
    		 Testosterone Placebo Strengh training + testim Strenght training + placebo Total
    Number of subjects
    		 20 20 10 10 60
    Age categorical
    Men 60 +
    Units: Subjects
        Adults (18-64 years)
    		 15 15 5 5 40
        From 65-84 years
    		 5 5 5 5 20
    Age continuous
    men 60 +
    Units: years
        median (full range (min-max))
    		 69 (60 to 78) 69 (60 to 78) 69 (60 to 78) 69 (60 to 78) -
    Gender categorical
    men
    Units: Subjects
        Female
    		 0 0 0 0 0
        Male
    		 20 20 10 10 60

    End points

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    End points reporting groups
    Reporting group title
    Testosterone
    Reporting group description
    		 testim gel 5-10 g/dag

    Reporting group title
    Placebo
    Reporting group description
    		 PLacebo gel for 6 months

    Reporting group title
    Strengh training + testim
    Reporting group description
    		 strenth training for 6 months (+ testim for the last 3 months)

    Reporting group title
    Strenght training + placebo
    Reporting group description
    		 Stength training for 6 months (+ placebo for the last 3 months)

    Subject analysis set title
    lean body mass
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    analysis of change in lean body mass after 6 months

    Primary: lean body mass

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    End point title
    		 lean body mass
    End point description
    change in lean body mass
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Testosterone Placebo Strengh training + testim Strenght training + placebo
    Number of subjects analysed
    20
    18
    10
    10
    Units: kg
        arithmetic mean (standard deviation)
    64.3 ( 7.6 )
    66.3 ( 8.2 )
    64.3 ( 7.6 )
    66.3 ( 8.2 )
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    The outcomes was compares by multiple linear regression analysis controlled for baseline values
    Comparison groups
    Testosterone v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    as requested by authority
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    testosterone
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Reporting group title
    strength training
    Reporting group description
    		 -

    Serious adverse events
    		 testosterone placebo strength training
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 testosterone placebo strength training
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 20 (25.00%)
    5 / 20 (25.00%)
    0 / 20 (0.00%)
    Skin and subcutaneous tissue disorders
    rash
         subjects affected / exposed
    5 / 20 (25.00%)
    5 / 20 (25.00%)
    0 / 20 (0.00%)
         occurrences all number
    5
    5
    5

    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/22190001
    http://www.ncbi.nlm.nih.gov/pubmed/21347608
    http://www.ncbi.nlm.nih.gov/pubmed/22918704
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