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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2005-000852-34
    Sponsor's Protocol Code Number:JB001/2005
    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:2005-11-10
    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 number2005-000852-34
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, controlado con placebo, sobre los efectos del tratamiento combinado de testosterona con un inhibidor de APE 5 en pacientes con Disfunción Eréctil que no responden al tratamiento único con inhibidores de APE 5.
    A.3.2Name or abbreviated title of the trial where available
    TADTEST
    A.4.1Sponsor's protocol code numberJB001/2005
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCETPARP
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name TESTOGEL
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Besins International
    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.3.1Product nameTestosterone gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE
    D.3.9.1CAS number 58-22-0
    D.3.9.3Other descriptive nameTESTOGEL
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.IMP: 2
    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 Information not present in EudraCT
    D.2.1.1.1Trade name CIALIS
    D.2.1.1.2Name of the Marketing Authorisation holderLILLY ICOS
    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.3.1Product nameTadalafil
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTADALAFIL
    D.3.9.1CAS number 171596-29-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Disfunción Eréctil
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10061461
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objetivo Principal
    El objetivo principal de este estudio es evaluar la eficacia del tratamiento combinado de Tadalafil y Testosterona para mejorar la función eréctil de pacientes con DE con niveles bajos o normales-bajos de testosterona que no responden al tratamiento con Tadalafil solo. Para ello se administrará testosterona de manera aleatoria, a doble ciego y controlada con placebo, mientras que el Tadalafil se administrará abiertamente.
    La principal variable de eficacia será el cambio medio desde el punto de partida en la puntuación del Campo de la Función Eréctil del IIFE (preguntas 1-5 + 15) con Tadalafil + Testosterona en comparación con Tadalafil + placebo
    E.2.2Secondary objectives of the trial
    Confirmar los efectos beneficiosos de la combinación de testosterona con Tadalafil en pacientes con DE que no responden al Tadalafil solo mediante la comparación de 2 grupos de pacientes (con Tadalafil + testosterona frente a Tadalafil + placebo) en los siguientes parámetros en diferentes momentos del estudio:
    ·índice de pacientes que responden al tratamiento, definido como los pacientes que hayan obtenido una puntuación de 4 o 5 en Q3 Y Q4 del IIFE
    ·índice de pacientes que hayan obtenido una puntuación > 26 en el CFE del IIFE (lo que se considera que define la función eréctil normal)
    ·puntuación media obtenida en las Preguntas 3 y 4 del IIFE
    ·puntuación media obtenida en los otros 4 campos del IIFE (Función Orgásmica, Deseo Sexual, Relaciones Satisfactorias, y Satisfacción General), así como en el total del IIFE (suma de las 15 preguntas).
    ·el porcentaje de respuestas “SÍ” a las preguntas 2, 3, 4 y 5 del Perfil de los Encuentros Sexuales (PES),
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Síntomas de DE durante 3 meses;
    2. Edad comprendida entre 45 y 80 años;
    3. Con relación heterosexual estable durante más de 3 meses y que prevé tener la misma pareja durante todo el periodo de estudio
    4. No ha respondido de manera satisfactoria a las dosis más altas disponibles de Tadalafil u oros inhibidores de FDE5 (20 mg de Tadalafil y Vardenafil, 100 mg de Sildenafil) administrados por lo menos en 4 ocasiones diferentes, definidos como:
    · Una puntuación de 2, 3 o 4 en la Pregunta n°3 del IIFE
    Y
    · Una puntuación de 2 o 3 en la Pregunta n°4 del IIFE;

    Evaluado antes de la Visita 1
    5. un nivel bajo a normal-bajo de testosterona sérica (sea en los niveles de testosterona total o biodisponible) con respecto al intervalo de hombres menores de 50 años. (TT < 4 ng/ml y/o TB < 1 ng/ml) según una primera evaluación anterior a la Visita 1 y una confirmación mediante una segunda valoración en el laboratorio central Biolille en una muestra de sangre de la Visita 1

    6. Accede a realizar cuatro intentos de mantener relaciones sexuales en 4 días diferentes durante las 4 semanas del periodo previo con 10 mg diarios de Tadalafil.
    7. Por lo menos el 50% de los intentos durante este periodo deberán ser fallidos según la respuesta “No” a una de las preguntas 1 (“¿Fue capaz de conseguir un poco de erección (algún agrandamiento del pene)?”), 2 (“¿Fue capaz de introducir el pene en la vagina de su pareja?”) o 3 (“¿Duró su erección lo suficiente como para tener una relación satisfactoria?”).
    8. Al final de la fase previa con 10 mg diarios de Tadalafil, el paciente deberá obtener:
    · una puntuación de 2, 3 o 4 en la Pregunta n°3 del IIFE

    Y
    · una puntuación de 2, 3 en la Pregunta n°4 del IIFE
    E.4Principal exclusion criteria
    1. Impotencia causada por otro desorden sexual primario (ej. Eyaculación precoz);
    2. Historial de implante de pene o deformidad significativa del pene;
    3. Índice de masa corporal >35kg/m2;
    4. Diabetes mellitus no controlada (nivel HbA1c > 10%). HbA1c se comprobará en el examen en todos los pacientes diabéticos o sospechosos de serlo;
    5. Trastornos tiroideos no controlados;
    6. Hiperprolactinemia diagnosticada (prolactina sérica ≥ 30ng/ml en un laboratorio local);
    7. Patología orgánica hipotálamo-pituitaria;
    8. Historial de alcohol, drogas o abuso de medicamentos en los 6 meses previos a la Visita 1,
    9. Insuficiencia renal definida como tratamiento con diálisis, con una aclaramiento de creatinina < 30 ml/mn, o creatinina sérica > 30 mg/ml;
    10. Insuficiencia hepática grave, Child-Pugh clase C, elevación de AST y/o ALT > 3 x LSN;
    11. Tensión sistólica > 170 o < 90 mm Hg o tensión diastólica > 110 o < 50 mm Hg en el examen;
    12. Enfermedad cardiaca en la que esté contraindicada cualquier actividad sexual;
    13. Angina inestable en los 6 meses anteriores a la Visita 1;
    14. Angina durante las relaciones sexuales en los 6 meses anteriores a la Visita 1;
    15. Infarto de miocardio en los 90 días anteriores a la Visita 1;
    16. Cirugía de la arteria coronaria, implante de by-pass o intervención coronaria precutánea (angioplastia o endoprótesis vascular) en los 90 días anteriores a la Visita 1;
    17. Alteraciones graves del ritmo cardiaco, ej. arritmia supraventricular con una respuesta ventricular >100 lpm. en reposo a pesar de tratamientos con medicamentos o dispositivos, historial de taquicardia ventricular espontánea o inducida que no responde al tratamiento (ritmo cardiaco > 100 lpm. durante ≥ 30 seg.) o fibrilación, implante de desfibrilador cardioversor automático, historial de parada cardiaca repentina) en los 6 meses anteriores a la Visita 1;
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia en el estudio se basará en el cambio medio desde el punto de partida en la puntuación del campo de la Función Eréctil del IIFE (preguntas 1-5 +15, puntuación total posible de 1 a 30).
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.6Cross over No
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 430
    F.4.2.2In the whole clinical trial 430
    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 Decision2006-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-27
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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
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