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    Summary
    EudraCT Number:2013-005135-24
    Sponsor's Protocol Code Number:ECDOPDEP2013
    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:2014-01-10
    Trial results View 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 number2013-005135-24
    A.3Full title of the trial
    Clinical Trial crossed athletic population according UGT2B17 polymorphism. Impact on the steroid profile
    Ensayo Clinico cruzado en población deportiva segun polimorfismo UGT2B17. Impacto en el perfil esteroideo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of consumption of testosterone in the steroid profile in athletic population
    Impacto del consumo de testoterona en el perfil esteroideo de la población deportiva
    A.3.2Name or abbreviated title of the trial where available
    ECDOPDEP2013
    ECDOPDEP2013
    A.4.1Sponsor's protocol code numberECDOPDEP2013
    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 SponsorCristina Fernandez Pérez
    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 supportMINISTERIO DE ECONOMIA Y COMPETITIVIDAD. Plan Nacional I+D+I de Investigación no orientada.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationfundacion para la investigación biomedica del hospital clínico San Carlos
    B.5.2Functional name of contact pointUCICEC
    B.5.3 Address:
    B.5.3.1Street Addressprofesor Martin Lagos s/n
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number00349133030003793
    B.5.5Fax number00349133030003515
    B.5.6E-mailfibucicec.hcsc@salud.madrid.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 testex elmu prolongatum 250 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDesma Laboratorio Farmacéutico, S.L
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular and intravenous use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE CIPIONATE
    D.3.9.1CAS number 58-20-8
    D.3.9.3Other descriptive nameTESTOSTERONE CIPIONATE
    D.3.9.4EV Substance CodeSUB04734MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sports doping
    Dopaje en deportisitas
    E.1.1.1Medical condition in easily understood language
    Sports doping
    Dopaje en deportisitas
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10043364
    E.1.2Term Testosterone
    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
    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.
    Contrastar variabilidad del perfil esteroideo en periodo 2
    meses frente a 2 días consecutivos.
    Desarrollo de modelo matemático válido para caracterizar perfil
    esteroideo en periodos de tiempo largos.
    E.2.2Secondary objectives of the trial
    Characterize modification of steroid profile when testosterone is administered.
    Develop an analytical method that based on the use of GC-MS/MS permits to decrease uncertainty for quantification of samples with low concentration.
    Determine the parameters of the steroid profile taht will be more stables and sensitive
    against the exogenous administration fo steroids of endogenous steroids.
    Study the genetic influence over the steroid profile when an administration take place.
    Evaluate the efficiency of the CIRMS analysis for the selected population, influence of the
    genetic factor.
    Compare the efficiency of CIRMS analysis and the mathematical model.
    Identify new metabolites that could be less affected for the deletion.
    Caracterizar alteración de perfil esteroideo si se administra Testosterona
    Validar procedimiento de análisis que permita minimizar la
    imprecision en la estimación del perfil esteroideo en casos con concentraciones bajas, 10ng/mL o
    inferiores.
    Determinar el perfil esteroideo que sea más estables y sensible a la
    administración exógena de esteroides.
    Estudiar el comportamiento de las variables del perfil esteroideo en función del polimorfismo de UGT2B17.
    Evaluar la eficacia del análisis CIRMS en función del genotipo
    Contrastar la eficacia del análisis CIRMS con la eficacia del modelo matemático desarrollado.
    Identificar otros metabolitos de testosterona que no se vean alterados por la deleción pero sí por la administración exógena de
    esteroides anabolizantes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    healthy athletes
    aged 18 to 50 years
    deportistas sanos
    edad comprendida de 18 a 50 años
    E.4Principal exclusion criteria
    men with prostate or breast carcinoma
    pregnant or lactating women
    athletes in treatments with drugs contraindicated according to summary product.
    Athletes submitted to doping test
    hombres con carcinoma de prostata o mama
    mujeres embarazadas o lactantes
    deportisitas con tratamientos con farmacos contraindicados según ficha tecnica
    deportistas a los que no realicen test de dopaje
    E.5 End points
    E.5.1Primary end point(s)
    Urine concentration of testosterone, epitestosterone, androsterone, etiocholanolone, dihydrotestosterone, dehydroepiandrosterone
    Concentración en orina de Testosterona, Epitestosterona, Androsterona, Etiocolanolona, Dehidrotestosterona, Dehidroepiandrosterona
    E.5.1.1Timepoint(s) of evaluation of this end point
    DAYs: 1, 11, 21, 31, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 56, 61, 66, 71, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 91, 96, 101, 106, 111, 121, 131, 141, 161, 171.
    Días: 1, 11, 21, 31, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 56, 61, 66, 71, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 91, 96, 101, 106, 111, 121, 131, 141, 161, 171.
    E.5.2Secondary end point(s)
    Study group, age, gender, impact of competition, date with time of collection of the urine sample, training hours day / week, hematological parameters of overtraining. Blood tests: hemoglobin, red blood cells, hematocrit, mean corpuscular volume, HCM, HCMC, reticulocytes, leukocytes, leukocyte distribution, platelets, platelet distribution, urea, creatinine, liver enzymes, CPK and blood testosterone cortisol ratio, SHBG
    Grupo de estudio, edad, sexo, efecto de la competición, fecha con hora de recogida de la muestra de orina, horas de entrenamiento día/semana, parámetros hematológicos de sobreentrenamiento. Analítica sanguínea: hemoglobina, glóbulos rojos, hematocrito, volumen corpuscular medio, HCM, HCMC, reticulocitos, leucocitos, distribución leucocitaria, plaquetas, distribución plaquetaria, urea, creatinina, enzimas hepáticas, CPK y relación cortisol testosterona en sangre, SHBG
    E.5.2.1Timepoint(s) of evaluation of this end point
    DAYs: 1, 11, 21, 31, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 56, 61, 66, 71, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 91, 96, 101, 106, 111, 121, 131, 141, 161, 171.
    Días: 1, 11, 21, 31, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 56, 61, 66, 71, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 91, 96, 101, 106, 111, 121, 131, 141, 161, 171.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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 Yes
    E.6.13.1Other scope of the trial description
    evaluation of a mathematical model to determine sports doping
    evaluación de un modelo matemático para determinar dopaje deportivo
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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 years1
    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: 30
    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 state30
    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 Decision2014-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
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