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    Clinical Trial Results:
    Denosumab and male infertility: a prospective intervention study

    Summary
    EudraCT number
    		 2015-000655-24
    Trial protocol
    		 DK  
    Global end of trial date
    10 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2021
    First version publication date
    25 Jun 2021
    Other versions
    Summary report(s)
    		 RANKL regulates male reproductive function

    Trial information

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    Trial identification
    Sponsor protocol code
    CBG-study2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dept. of growth and reproduction
    Sponsor organisation address
    Blegdamsvej 9, copenhagen, Denmark, 2100
    Public contact
    martin blomberg jensen, rigshospitalet, 45 35451865, blombergjensen@gmail.com
    Scientific contact
    martin blomberg jensen, rigshospitalet, 45 35451865, blombergjensen@gmail.com
    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
    10 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to investigate whether short term Denosumab treatment can imporve sperm count and male fertility
    Protection of trial subjects
    regular blood sampling and clinical controls at department
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Mar 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: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 through out patient clinic

    Pre-assignment
    Screening details
    		 male infertility

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    no blinding. Only one arm

    Arms
    Arm title
    		 Denosumab
    Arm description
    		 denosumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    denosumab
    Investigational medicinal product code
    9001231
    Other name
    prolia
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    60 mg s.c. once

    Number of subjects in period 1
    		Denosumab
    Started
    12
    Completed
    10
    Not completed
    2
         excluded as per protocol due to high fever
    1
         Lost to follow-up
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Denosumab
    Reporting group description
    		 denosumab

    Primary: change in semen concentration

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    End point title
    		 change in semen concentration [1]
    End point description
    End point type
    Primary
    End point timeframe
    180 days
    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 only ONE ARM in this study. We performed ANOVA with Dunnett's post hoc test, comparing changes in semen quality to baseline values.
    End point values
    		 Denosumab
    Number of subjects analysed
    10
    Units: mill/ml
        number (not applicable)
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    180 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD10
    Dictionary version
    1
    Reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    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: We did not experince non-serious adverse events
    Serious adverse events
    		 overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Appendicitis
    Additional description: one man had an appendicitis during the study period. This was assessed as UNRELATED TO IMP
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 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
    0 / 12 (0.00%)

    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/33893301
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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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