Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44306   clinical trials with a EudraCT protocol, of which   7355   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Clinical Trial crossed athletic population according UGT2B17 polymorphism. Impact on the steroid profile

    Summary
    EudraCT number
    		 2013-005135-24
    Trial protocol
    		 ES  
    Global end of trial date
    16 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2022
    First version publication date
    10 Feb 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ECDOPDEP2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundacion para la investigación biomedica del hospital clínico San Carlos
    Sponsor organisation address
    Calle del Prof Martín Lagos, s/n, , madrid, Spain,
    Public contact
    UCICEC, fundacion para la investigación biomedica del hospital clínico San Carlos, 0034 9133030003793, fibucicec.hcsc@salud.madrid.org
    Scientific contact
    UCICEC, fundacion para la investigación biomedica del hospital clínico San Carlos, 0034 9133030003793, fibucicec.hcsc@salud.madrid.org
    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
    Interim
    Date of interim/final analysis
    16 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Contrast variability of steroid profile during at least periods of time of two months versus the model developed from 2 days based model. Follow development of mathematical model implemented to characterized steroid profile during long periods of time.
    Protection of trial subjects
    This is a non-commercial study financed by the National R&D&I Plan for Non-Oriented Research. Once approved, an insurance policy will be taken out.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 May 2014
    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
    Spain: 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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Healthy athletes between 18 and 55 years of age, of both sexes, from different sports specialties who have completed the previous study (DEP2009-14788-C01-C03).

    Period 1
    Period 1 title
    PRE
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst
    Blinding implementation details
    the results of a triple-blind randomized placebo-controlled crossover trial

    Arms
    Arm title
    		 placebo
    Arm description
    		 3 groups: del/del n=4; del/ins n=4, ins/ins or WT n=4
    Arm type
    		 Active comparator

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

    Number of subjects in period 1
    		placebo
    Started
    12
    Completed
    12
    Period 2
    Period 2 title
    POST
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst

    Arms
    Arm title
    		 testex
    Arm description
    		 3 groups: del/del n=4; del/ins n=4, ins/ins or WT n=4
    Arm type
    		 Experimental

    Investigational medicinal product name
    TESTEX ELMU PROLONGATUM
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    TESTEX ELMU PROLONGATUM  2 ml with Testosterone Cyclopentyl Propionate250 mg (injectable).

    Number of subjects in period 2
    		testex
    Started
    12
    Completed
    12

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 3 groups: del/del n=4; del/ins n=4, ins/ins or WT n=4

    Reporting group values
    		 placebo Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.9 ( 11.2 ) -
    Gender categorical
    Units: Subjects
        Male
    		 12 12

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 3 groups: del/del n=4; del/ins n=4, ins/ins or WT n=4
    Reporting group title
    testex
    Reporting group description
    		 3 groups: del/del n=4; del/ins n=4, ins/ins or WT n=4

    Primary: Contrast variability of steroid profile during at least periods of time of two months versus the model developed from 2 days based model.

    		 Close Top of page
    End point title
    		 Contrast variability of steroid profile during at least periods of time of two months versus the model developed from 2 days based model.
    End point description
    End point type
    Primary
    End point timeframe
    Forty urine samples were collected from each participant over 7 months
    End point values
    		 placebo testex
    Number of subjects analysed
    12
    12
    Units: testosterone/epistestosterone(T/E) ratio
        number (not applicable)
    12
    12
    Statistical analysis title
    		 Steroid profile characterization
    Comparison groups
    placebo v testex
    Number of subjects included in analysis
    24
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    During the course of the study there have been no withdrawals from the study, no serious adverse events, no major protocol deviations and no deaths during the study period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 unkwon
    Dictionary version
    unkwon
    Frequency threshold for reporting non-serious adverse events: 0%
    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 non-serious adverse events due to lack of recruitment

    More information

    		 Close Top of page

    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.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA