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    Clinical Trial Results:
    Influence of aromatase inhibitors on insulin sensitivity, liver and hart function in obese men

    Summary
    EudraCT number
    		 2013-002964-22
    Trial protocol
    		 BE  
    Global end of trial date
    15 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Dec 2021
    First version publication date
    02 Dec 2021
    Other versions
    Summary report(s)
    		 Statement of discontinuation

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2013/009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Cormaal Hetmanslaan 10, Ghent, Belgium, 9000
    Public contact
    HIRUZ CTY, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    HIRUZ CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    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
    15 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate potential effects and causes of changed sex steroids in obese men
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 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
    Belgium: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 1 patients were screened in the period from dand included before discontinuation of the trial. End of trial notification was dated 15-Jun-2015 (last patient last visit) and submitted to EC and CA 24-Jun-2015

    Pre-assignment
    Screening details
    		 Main inclusion criteria: Adult obese mails with low testosteron scheduled for gastric bypass

    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, Carer, Assessor

    Arms
    Arm title
    		 Letrozole
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Letrozole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 mg every 2 days during 4 months

    Number of subjects in period 1
    		Letrozole
    Started
    1
    Completed
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Letrozole
    Reporting group description
    		 -

    Primary: Insulin sensitivity

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    End point title
    		 Insulin sensitivity [1]
    End point description
    End point type
    Primary
    End point timeframe
    Difference between start of treatment and end of treatment (4 months)
    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 analysis done as study has discontinued
    End point values
    		 Letrozole
    Number of subjects analysed
    1 [2]
    Units: mg/dl
        number (not applicable)
    1
    Notes
    [2] - Not analysed as study ended prematurly
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events were collected during the trial

    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
    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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