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    Clinical Trial Results:
    Testosterone replacement therapy in hypogonadal men with nonalcoholic steatohepatitis (TEREPINS)

    Summary
    EudraCT number
    		 2012-002564-27
    Trial protocol
    		 GB  
    Global end of trial date
    30 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2021
    First version publication date
    23 May 2021
    Other versions
    Summary report(s)
    		 Final study report

    Trial information

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    Trial identification
    Sponsor protocol code
    STH16037
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01919294
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sheffield Teaching Hospitals NHS Foundation Trust
    Sponsor organisation address
    Trust Headquarters, 8 Beech Hill Road, Sheffield, United Kingdom, S10 2SB
    Public contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.net
    Scientific contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.net
    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
    30 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In hypogonadal men with non-alcoholic steatohepatitis (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months, improve severity of steatosis assessed by liver biopsy?
    Protection of trial subjects
    All participants were given a participant information sheet to read and consider for at least 24 hours. Participants were reviewed by a clinician who was delegated to this task, according to the strict inclusion and exclusion criteria. All participants give written informed consent prior to enrolment to the study.
    Background therapy
    		 -
    Evidence for comparator
    		 Single arm. No comparators were used.
    Actual start date of recruitment
    06 Feb 2013
    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
    United Kingdom: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    2
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Men with NAFLD and some inflammation or scarring (proven on liver biopsy performed for clinical diagnosis) and who had mildly reduced testosterone levels were recruited from NHS clinics in Sheffield, UK.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 3
    Number of subjects completed
    		 3

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded. All participants received the same treatment.

    Arms
    Arm title
    		 Treatment, baseline results
    Arm description
    		 As per EudraCT FAQs dated 24Nov2020, this arm represents participant's baseline results. Guidance: In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed. One of the two comparison groups can be defined in the subject disposition, and the other(s) in section “baseline characteristics” within the “Subject analysis set” functionality. You can then select both comparison groups in each “Endpoint definition” section. Please note that this is a workaround in order to accommodate reporting of single arm trials results.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nebido
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Testosterone Undecanoate (1 g in 4 ml oily base) was given as slow (2 minute) intramuscular injections (Nebido, manufactured by Bayer-Schering). Given at time zero (baseline visit 2) and after 6, 18, 30 and 42 weeks.

    Number of subjects in period 1
    		Treatment, baseline results
    Started
    3
    Completed
    3

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 3 3
    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)
    		 2 2
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Treatment, baseline results
    Reporting group description
    		 As per EudraCT FAQs dated 24Nov2020, this arm represents participant's baseline results. Guidance: In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed. One of the two comparison groups can be defined in the subject disposition, and the other(s) in section “baseline characteristics” within the “Subject analysis set” functionality. You can then select both comparison groups in each “Endpoint definition” section. Please note that this is a workaround in order to accommodate reporting of single arm trials results.

    Subject analysis set title
    Treatment, 52 weeks results
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    As per EudraCT FAQs 24 November 2020, this group represents participant's data at 52 weeks. Guidance: In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed. One of the two comparison groups can be defined in the subject disposition, and the other(s) in section “baseline characteristics” within the “Subject analysis set” functionality. You can then select both comparison groups in each “Endpoint definition” section. Please note that this is a workaround in order to accommodate reporting of single arm trials results.

    Primary: Change in steatosis

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    End point title
    		 Change in steatosis [1]
    End point description
    As per EudraCT FAQs 24 November 2020, the group 'subject disposition, period one overall trial' represents the baseline data for participants and the group 'baseline characteristics/subject analysis set' represents the data at 52 weeks for participants. Guidance: In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed. One of the two comparison groups can be defined in the subject disposition, and the other(s) in section “baseline characteristics” within the “Subject analysis set” functionality. You can then select both comparison groups in each “Endpoint definition” section. Please note that this is a workaround in order to accommodate reporting of single arm trials results.
    End point type
    Primary
    End point timeframe
    Baseline to 52 weeks
    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: There is no statistical analysis provided for this endpoint as the trial recruited only three participants and therefore performing formal statistics is not justified; the calculations lack sufficient power.
    End point values
    		 Treatment, baseline results Treatment, 52 weeks results
    Number of subjects analysed
    3
    3
    Units: Graded 1-3
        median (full range (min-max))
    2 (2 to 2)
    1 (1 to 1)
    No statistical analyses for this end point

    Secondary: Hepatocyte ballooning

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    End point title
    		 Hepatocyte ballooning
    End point description
    As per EudraCT FAQs 24 November 2020, the group 'subject disposition, period one overall trial' represents the baseline data for participants and the group 'baseline characteristics/subject analysis set' represents the data at 52 weeks for participants. Guidance: In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed. One of the two comparison groups can be defined in the subject disposition, and the other(s) in section “baseline characteristics” within the “Subject analysis set” functionality. You can then select both comparison groups in each “Endpoint definition” section. Please note that this is a workaround in order to accommodate reporting of single arm trials results.
    End point type
    Secondary
    End point timeframe
    Baseline to 52 weeks
    End point values
    		 Treatment, baseline results Treatment, 52 weeks results
    Number of subjects analysed
    3
    3
    Units: Graded 1-3
        median (full range (min-max))
    3 (2 to 3)
    1 (1 to 1)
    No statistical analyses for this end point

    Secondary: Brunt (inflammatory grade)

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    End point title
    		 Brunt (inflammatory grade)
    End point description
    As per EudraCT FAQs 24 November 2020, the group 'subject disposition, period one overall trial' represents the baseline data for participants and the group 'baseline characteristics/subject analysis set' represents the data at 52 weeks for participants. Guidance: In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed. One of the two comparison groups can be defined in the subject disposition, and the other(s) in section “baseline characteristics” within the “Subject analysis set” functionality. You can then select both comparison groups in each “Endpoint definition” section. Please note that this is a workaround in order to accommodate reporting of single arm trials results.
    End point type
    Secondary
    End point timeframe
    Baseline to 52 weeks
    End point values
    		 Treatment, baseline results Treatment, 52 weeks results
    Number of subjects analysed
    3
    3
    Units: inflammatory grade
        median (full range (min-max))
    3 (2 to 3)
    1 (1 to 1)
    No statistical analyses for this end point

    Secondary: Fibrosis (central)

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    End point title
    		 Fibrosis (central)
    End point description
    As per EudraCT FAQs 24 November 2020, the group 'subject disposition, period one overall trial' represents the baseline data for participants and the group 'baseline characteristics/subject analysis set' represents the data at 52 weeks for participants. Guidance: In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed. One of the two comparison groups can be defined in the subject disposition, and the other(s) in section “baseline characteristics” within the “Subject analysis set” functionality. You can then select both comparison groups in each “Endpoint definition” section. Please note that this is a workaround in order to accommodate reporting of single arm trials results.
    End point type
    Secondary
    End point timeframe
    Baseline to 52 weeks
    End point values
    		 Treatment, baseline results Treatment, 52 weeks results
    Number of subjects analysed
    3
    3
    Units: Central grading
        median (full range (min-max))
    5 (4 to 5)
    2 (2 to 2)
    No statistical analyses for this end point

    Secondary: Change in liver enzymes - ALT

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    End point title
    		 Change in liver enzymes - ALT
    End point description
    As per EudraCT FAQs 24 November 2020, the group 'subject disposition, period one overall trial' represents the baseline data for participants and the group 'baseline characteristics/subject analysis set' represents the data at 52 weeks for participants. Guidance: In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed. One of the two comparison groups can be defined in the subject disposition, and the other(s) in section “baseline characteristics” within the “Subject analysis set” functionality. You can then select both comparison groups in each “Endpoint definition” section. Please note that this is a workaround in order to accommodate reporting of single arm trials results.
    End point type
    Secondary
    End point timeframe
    Baseline to 52 weeks
    End point values
    		 Treatment, baseline results Treatment, 52 weeks results
    Number of subjects analysed
    3
    3
    Units: international unit(s)/litre
        median (inter-quartile range (Q1-Q3))
    77 (56 to 98)
    88 (51 to 133)
    No statistical analyses for this end point

    Secondary: Change in liver enzymes - Alk-Phos

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    End point title
    		 Change in liver enzymes - Alk-Phos
    End point description
    As per EudraCT FAQs 24 November 2020, the group 'subject disposition, period one overall trial' represents the baseline data for participants and the group 'baseline characteristics/subject analysis set' represents the data at 52 weeks for participants. Guidance: In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed. One of the two comparison groups can be defined in the subject disposition, and the other(s) in section “baseline characteristics” within the “Subject analysis set” functionality. You can then select both comparison groups in each “Endpoint definition” section. Please note that this is a workaround in order to accommodate reporting of single arm trials results.
    End point type
    Secondary
    End point timeframe
    Baseline to week 52
    End point values
    		 Treatment, baseline results Treatment, 52 weeks results
    Number of subjects analysed
    3
    3
    Units: international unit(s)/litre
        median (inter-quartile range (Q1-Q3))
    165 (79 to 184)
    136 (75 to 150)
    No statistical analyses for this end point

    Secondary: Change in HOMA

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    End point title
    		 Change in HOMA
    End point description
    As per EudraCT FAQs 24 November 2020, the group 'subject disposition, period one overall trial' represents the baseline data for participants and the group 'baseline characteristics/subject analysis set' represents the data at 52 weeks for participants. Guidance: In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed. One of the two comparison groups can be defined in the subject disposition, and the other(s) in section “baseline characteristics” within the “Subject analysis set” functionality. You can then select both comparison groups in each “Endpoint definition” section. Please note that this is a workaround in order to accommodate reporting of single arm trials results.
    End point type
    Secondary
    End point timeframe
    Baseline to 52 weeks
    End point values
    		 Treatment, baseline results Treatment, 52 weeks results
    Number of subjects analysed
    3
    3
    Units: HOMA index
        median (inter-quartile range (Q1-Q3))
    19.5 (12.5 to 73.8)
    14.4 (13.2 to 15.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent until 4 weeks after the end of participant's involvement in trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All participants throughout trial

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    Blood and lymphatic system disorders
    Polycythaemia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Infections and infestations
    Chest infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    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.
    Three participants were recruited whereas it was initially intended that there would be 10 recruits.
    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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