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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2004-001545-15
    Sponsor's Protocol Code Number:307720
    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:2005-04-13
    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 number2004-001545-15
    A.3Full title of the trial
    Estudio multicéntrico, doble ciego, aleatorizado, controlado con placebo de Testogel® (testosterona 50–100mg) para evaluar su eficacia y seguridad en hombres que presentan síntomas típicos de deficit androgénico parcial en la edad avanzada (PADAM) durante un periodo de 6 meses, con un seguimiento abierto de 12 meses
    A.3.2Name or abbreviated title of the trial where available
    European Testogel study in PADAM
    A.4.1Sponsor's protocol code number307720
    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 SponsorSchering AG
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 holderLaboratories 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 nameTestogel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 58-22-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 100
    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 Information not present in EudraCT
    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
    Déficit Androgénico parcial en la edad avanzada.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar el cambio en masa corporal magra tras 6 meses de tratamiento con Testogel® (50mg a 75mg de testosterona/ día) comparado con placebo, medido mediante Absorciometría dual de energía por rayos X (DEXA; Dual energy X-ray absorptiometry).
    E.2.2Secondary objectives of the trial
    -Evaluar el cambio en la masa corporal magra durante el tratamiento abierto con Testogel® desde los 6 a los 18 meses del estudio (durante este periodo, los pacientes aleatorizados a Testogel® recibirán su tratamiento correspondiente a los meses 6 a 18, y los pacientes aleatorizados a placebo empezarán el tratamiento con Testogel® y recibirán hasta 12 meses de tratamiento activo).

    -Evaluar los cambios en la masa corporal magra, medida por DEXA dentro de 3 estratos definidos por la testosterona total medida en el laboratorio central en la visita de selección:
    <10nmol/l (2.9ng/ml)
    10 a <12nmol/l (2.9 a <3.5ng/ml)
    12 a 15nmol/l (3.5 a 4.3ng/ml)

    -Evaluar el cambio en la masa corporal total, masa grasa y densidad ósea, medida por DEXA
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Varones de entre 50 y 80 años, ambos inclusive

    2. Hipogonadismo sintomático definido por i e ii:
    i. Testosterona Total ≤ 15nmol/l (≤ 4.3ng/ml), se calculará la testosterona biodisponible9 a partir de la testosterona total y hormonas sexuales, debiendo ser ≤ 4.43nmol/l (≤ 1.28ng/ml)
    ii. Puntuación Sintomática de la escala AMS > 36

    3. Que acepte evitar cambios significativos en la pauta de ejercicio físico y estilo de vida durante todo el estudio

    4. Que acepte firmar voluntariamente la hoja de consentimiento informado para participar en el estudio
    E.4Principal exclusion criteria
    1. Uso de tratamiento androgénico o esteroides anabolizantes dentro de los 12 meses previos a la entrada en el estudio (es decir de la visita de selección/ visita 1)
    2. Contraindicaciones para el tratamiento con Testogel® de acuerdo con la Ficha Técnica
    3. Hipersensibilidad a las sustancias activas o a cualquiera de los excipientes de Testogel®
    4. Extensas anormalidades en la piel que pudieran afectar a la absorción del gel
    5. Diagnóstico de apnea del sueño
    6. Policitemia
    7. Hematocrito > 50% a la entrada del estudio (es decir, visita de selección/ visita 1)
    8. Prolactina > 25ng/ml
    9. Patología orgánica hipotalámico-pituitaria
    10. Enfermedad psiquiátrica grave
    11. Antígeno prostático específico(PSA) ≥ 4ng/ml
    12. Hiperplasia prostática benigna sintomática grave (suma de la escala IPSS > 20)
    13. Uso simultáneo de andrógenos, incluyendo dehidroepiandrostenora (DHEA), esteroides anabólicos, clomipramina, antiandrógenos, estrógenos, medicamentos que inducen el citocromo P 450 (por ejemplo, quinidina, ketoconazol, macrolidos) , corticotrofinas (ACTH), oxifenbutazona
    14. Índice de masa corporal (IMC) > 35kg/m2
    15. Enfermedades tiroideas no controladas
    16. Diabetes mellitus con cambios vasculares o incontrolada
    17. Epilepsia sin controlar adecuadamente con tratamiento
    18. Pacientes que necesitan tratamiento de fertilidad
    19. Cualquier enfermedad crónica clínicamente significativa que pudiera, en opinión del investigador, comprometa la seguridad del paciente, interfiera con las evaluaciones, o impida completar el estudio (por ejemplo, hemocromatosis, enfermedad pulmonar crónica, síndrome de malabsorción crónica)
    20. Antecedentes de abuso de drogas o alcohol
    21. Trastornos médicos, psiquiátricos u otros que comprometen la capacidad del paciente de entender la información al paciente, dar el consentimiento informado, cumplir el protocolo del ensayo o finalizar el estudio.
    22. Hipertensión que no esté adecuadamente controlada con tratamiento
    23. Insuficiencia cardiaca, hepática o renal graves
    24. Sospechas o actual o antecedentes personales de cáncer de próstata o cáncer de mama
    25. Implantes metálicos en el cuerpo (los implantes metálicos en la cabeza no excluyen la participación del paciente)
    26. Aleatorización previa en este estudio
    27. Participación simultánea con otro ensayo clínico durante el mes previo a la entrada en este estudio (es decir, visita de selección/ visita 1) o durante toda la duración del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - La variable primaria de eficacia es el cambio en la masa corporal magra después de 6 meses. Se hará una comparación entre los varones tratados con Testogel® y los varones tratados con placebo.

    - Las variables secundarias de eficacia son cambios en la composición corporal (masa magra, masa corporal total, masa grasa y densidad mineral ósea), AMS y cambios en la testosterona.

    - Las variables de seguridad están basadas en los acontecimientos adversos que se puedan producir a lo largo del estudio
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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
    El final del estudio está definido como la última visita del último 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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 360
    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)
    Los pacientes recibirán el tratamiento normal para su patología a criterio del médico tratante
    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 Decision2004-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-06-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-10-10
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