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    Summary
    EudraCT Number:2014-001655-23
    Sponsor's Protocol Code Number:01-testgel-14
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-001655-23
    A.3Full title of the trial
    Establishment of an Athlete's Internal Metabolic Reference Using an Isotopic Signature or Isotopic Fingerprint of ?13C Values
    DETERMINACIÓN DE LA HUELLA ISOTÓPICA DE LOS METABOLITOS DE TESTOSTERONA. APLICACIÓN PARA LA DETECCIÓN DEL CONSUMO DE TESTOSTERONA EN FORMA DE GEL EN EL DEPORTE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DETECTION OF CONSUMPTION OF TESTOSTERONE GEL IN SPORT.
    DETECCIÓN DEL CONSUMO DE TESTOSTERONA GEL EN EL DEPORTE
    A.3.2Name or abbreviated title of the trial where available
    testgel
    testgel
    A.4.1Sponsor's protocol code number01-testgel-14
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRodrigo Aguilera
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportagencia española de proteccion de la salud en el deporte
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAgencia Española de proteccion de la salud en el deporte
    B.5.2Functional name of contact pointAgencia Española de proteccion de l
    B.5.3 Address:
    B.5.3.1Street Addresspintor el greco
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number349154198299829
    B.5.5Fax number349154372907290
    B.5.6E-mailrodrigo.aguilera@aepsad.gob.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name testim gel
    D.2.1.1.2Name of the Marketing Authorisation holderFerring S.A.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE
    D.3.9.1CAS number SUB10937MIG
    D.3.9.2Current sponsor codeSUB10937MIG
    D.3.9.3Other descriptive nameSUB10937MIG
    D.3.9.4EV Substance CodeSUB10937MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SPORT DOPING
    DOPAGE EN EL DEPORTE
    E.1.1.1Medical condition in easily understood language
    SPORT DOPING
    DOPAGE EN EL DEPORTE
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10059568
    E.1.2Term Urine dihydrotestosterone
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine urinary parameters which are most effective to implement an analytical method to detect the application of testosterone gel
    determinar que parámetros urinarios son más eficaces para implementar un método de análisis que permita detectar la aplicación de testosterona gel
    E.2.2Secondary objectives of the trial
    To increase interlaboratory homegenidad.
    Reduce costs in the current methodology.
    Implement the isotopic fingerprint as an element of longitudinal follow-up.
    Incrementar la homegenidad interlaboratorio.
    Reducir costes en la metodologia actual.
    Implementar la huella isotópica como elemento de seguimiento longitudinal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Not to be taking or having taken doping products.
    - Not to be susceptible to doping control
    - Age between 18-40 years.
    - Women without contraceptives or pregnant prior pregnancy test done.
    - Diseases that may be affected by the scheduled administration.
    No estar ingiriendo o haber ingerido productos dopantes.
    No sean deportistas susceptibles de pasar un control de dopaje
    Estar dentro de la franja de edad entre 18-40 años.
    Que las mujeres no estén tomando anticonceptivos, ni estén embarazadas se hace un test de embarazo previo).
    Que los voluntarios no sufran de patologías que puedan verse afectadas por la administración programada.
    E.4Principal exclusion criteria
    To have taken doping products in the past year.
    Athletes susceptible to doping control
    Women whor are taking contraceptives, or who are pregnant.
    Pathologies that may be affected by the scheduled administration.
    Hypertension, metabolic disorders (hyperlipidemia), endocrine disorders (diabetes, hypothyroidism, adrenal gland disorders), acne, psychiatric disorders, genitourinary disordres.
    Haber ingerido productos dopantes en el último año.
    Deportistas susceptibles de pasar un control de dopaje.
    Mujeres estén tomando anticonceptivos, o que estén embarazadas (se les realiza prueba de embarazo antes de la aplicación del gel o placebo)
    Patologías que se puedan ver afectadas por la administración programada.
    Hipertensión, alteraciones metabólicas (hiperlipidemias), Alteraciones endocrinológicas (diabetes, hipotiroidismo, alteraciones de glándulas suprarrenales), acné, alteraciones psiquiátricas, alteraciones genitourinarias.
    E.5 End points
    E.5.1Primary end point(s)
    Testosterone concentration
    Concentracion de Testosterona
    E.5.1.1Timepoint(s) of evaluation of this end point
    one per month during the first year, every day during drug and placebo administration, one per week during washout period
    una al mes durante un año, una al día durante la aplicación de placebo y gel y una semanal durante el periodo de lavado de las sustancias
    E.5.2Secondary end point(s)
    Concentration for: epitestosterone, androsterone, etiocholanolone 5-androstenediol, 5-androstenediol.
    13C content: Testosterone, epitestosterone, androsterone, etiocholanolone 5-androstenediol, 5-androstenediol and pregnandiol.
    Concentracion de : epitestosterona, androsterona, etiocolanolona, 5-androstendiol, 5-androstendiol.
    Contenido de 13C en: Testosterona, epitestosterona, androsterona, etiocolanolona, 5-androstendiol, 5-androstendiol y pregnandiol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    one per month during the first year, every day during drug and placebo administration, one per week during washout period
    una al mes durante un año, una al día durante la aplicación de placebo y gel y una semanal durante el periodo de lavado de las sustancias
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    lvls
    ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
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