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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7337   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:2006-001228-37
    Sponsor's Protocol Code Number:BAY38-9456/12146
    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:2006-07-06
    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 number2006-001228-37
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, controlado con placebo para investigar la eficacia de vardenafilo a dosis flexible en sujetos con disfunción eréctil y en la calidad de la vida sexual de sus parejas. Estudio PARTNER II
    A.3.2Name or abbreviated title of the trial where available
    PARTNER II
    A.4.1Sponsor's protocol code numberBAY38-9456/12146
    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 SponsorBayer HealthCare AG, D-51368 Leverkusen
    B.1.3.4CountrySpain
    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 Yes
    D.2.1.1.1Trade name Levitra
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 namevardenafil HCL
    D.3.2Product code Bay 38-9456
    D.3.4Pharmaceutical form Film-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 INNvardenafil
    D.3.9.1CAS number 224785-91-5
    D.3.9.2Current sponsor codeBay 38-9456
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 No
    D.3.11.8Extractive medicinal product No
    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 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 Levitra
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 namevardenafil HCL
    D.3.2Product code Bay 38-9456
    D.3.4Pharmaceutical form Film-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 INNvardenafil
    D.3.9.1CAS number 224785-91-5
    D.3.9.2Current sponsor codeBay 38-9456
    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 No
    D.3.11.8Extractive medicinal product No
    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: 3
    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 Levitra
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 namevardenafil HCL
    D.3.2Product code Bay 38-9456
    D.3.4Pharmaceutical form Film-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 INNvardenafil
    D.3.9.1CAS number 224785-91-5
    D.3.9.2Current sponsor codeBay 38-9456
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    D.3.11.8Extractive medicinal product No
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Varones con Disfunción Eréctil
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10061461
    E.1.2Term Erectile dysfunction
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es comparar la eficacia del tratamiento con vardenafilo a dosis flexible frente a placebo durante 12 semanas en cuanto a:
    1.Éxito del mantenimiento de la erección en hombres con DE y
    2.Mejora de la calidad de la vida sexual de las respectivas parejas femeninas
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Sujeto:
    •Varones que hayan sufrido DE durante al menos seis meses
    •Una relación heterosexual estable durante más de seis meses.
    •Varones de entre 18 y 64 años de edad
    •Consentimiento informado documentado por escrito y fechado.
    •El sujeto y su pareja femenina deben realizar como mínimo 4 intentos de relación sexual en cuatro días distintos durante el periodo inicial sin tratamiento
    •Al menos el 50% de los intentos de relación sexual durante el periodo inicial sin tratamiento deberán tener un desenlace no favorable.

    Pareja:
    •Mujeres a partir de 18 años de edad.
    •Relación heterosexual estable durante más de seis meses con un sujeto con DE.
    •Consentimiento informado documentado por escrito y fechado.
    •Motivadas para animar a sus parejas masculinas con DE a que se sometan al tratamiento.
    •Ausencia de una disfunción sexual significativa valorada mediante la puntuación total del FSFI > 23,55.
    E.4Principal exclusion criteria
    Sujeto:

    A)Enfermedades actuales o previas
    •Cualquier trastorno por abuso de sustancias o de tipo psiquiátrico o médico inestable que, según el investigador, pueda afectar la capacidad del sujeto para completar el estudio o excluya la participación de éste en el estudio.
    •Presencia de anomalías anatómicas peneanas (p. ej. fibrosis peniana o enfermedad de Peyronie) que, según el investigador, puedan perjudicar de forma significativa el rendimiento sexual.
    •Deseo sexual primario hipoactivo.
    •Lesión de la médula espinal.
    •Antecedentes de prostactectomía quirúrgica ( las intervenciones transuretrales se permiten).
    •Trastornos retinianos degenerativos hereditarios como retinitis pigmentosa.
    •Pérdida de visión de un ojo debido a NOAI-NA
    •Cualquier enfermedad cardiovascular subyacente incluida la angina de pecho, que excluya la actividad sexual.
    •Antecedentes de infarto de miocardio, accidente cerebrovascular o arritmia potencialmente mortal durante los seis meses anteriores.
    •Flutter/fibrilación auricular descontrolada durante la selección (frecuencia de respuesta ventricular ≥ 100 pulsaciones por minuto).
    •Hepatopatía aguda o crónica grave (Child-Pugh B), antecedentes de insuficiencia hepática moderada o grave (Child-Pugh C).
    •Enfermedad hematológica crónica clínicamente significativa que pueda provocar priapismo como anemia drepanocítica, mieloma múltiple y leucemia.
    •Trastorno hemorrágico.
    •Ulcera péptica activa significativa.
    •Hipotensión en reposo (tensión arterial sistólica en reposo < 90 mm Hg) o hipertensión (tensión arterial sistólica en reposo > 170 mm Hg o tensión arterial diastólica en reposo > 110 mm Hg).
    •Antecedentes de cáncer en los últimos cinco años (distinto de carcinoma basocelular o espinocelular).
    •Antecedentes de prueba positiva del antígeno de superficie de la hepatitis B o C.
    •Hipotensión postural sintomática durante los seis meses posteriores a la Visita 1.

    B)Medicación concomitante
    •Sujetos que están tomando nitratos o sustancias que liberen óxido nítrico.
    •Sujetos que están tomando andrógenos orales o inyectables.
    •Sujetos que están tomando antiandrógenos.
    •Sujetos que están tomando los inhibidores potentes del citocromo P450 3A4 siguientes: inhibidores de la proteasa del VIH como ritonavir o indinavir, los antimicóticos itraconazol y ketoconazol (las formas tópicas están permitidas) o eritromicina.
    •Sujetos que hayan recibido cualquier producto en fase de investigación clínica (incluyendo placebo) durante los 30 días anteriores a la Visita 1.
    •Uso de cualquier tratamiento para la DE durante los siete días anteriores a la Visita 1 o durante el estudio, incluyendo medicación oral, dispositivos de vacío, inyecciones o supositorios uretrales.
    •Sujetos que tomen alfabloqueantes en Visita 1.

    C)Valores anormales de laboratorio
    •Sujetos con una concentración plasmática total de testosterona más del 25% por debajo del límite inferior del valor normal ajustado por edad en función del intervalo del laboratorio donde se realiza el análisis.
    •Sujetos con una depuración de creatinina sérica (calculada) < 30,0 mg/ml.
    •Elevación de AST o ALT > 3 veces el límite superior del valor normal.

    Criterios de exclusión: Pareja
    •Cualquier enfermedad inestable o trastorno por abuso de sustancias que, según el investigador, pueda afectar la capacidad de la pareja para completar el estudio o excluya la participación de ésta en el estudio.

    C) Otros criterios de exclusión: Sujeto y pareja
    •Sujetos que no deseen dejar de utilizar dispositivos de vacío, inyecciones intracavernosas o cualquier otro tratamiento para la DE durante el estudio.
    •Indisponibilidad por parte del sujeto y de su pareja para realizar cuatro intentos de relación sexual en cuatro días distintos durante el periodo inicial sin tratamiento.
    •Sujetos con hipersensibilidad conocida al vardenafilo, BAY 38-9456 o a cualquier componente de la medicación en fase de investigación clínica.
    •Sujetos analfabetos o que no entiendan los cuestionarios o el diario del sujeto.
    •Sujetos que no deseen o no puedan completar el diario del sujeto.
    •Sujetos con antecedentes de ausencia de respuesta a cualquier tratamiento con un inhibidor de la PDE5 debido a la falta de eficacia o a acontecimientos adversos que provoquen la interrupción del tratamiento con un inhibidor de la PDE5.
    •Parejas analfabetas o que no entiendan los cuestionarios.
    •Sujetos o parejas que, según el investigador, no cumplirían el programa de visitas incluido de los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Eficacia:
    Las medidas principales de la eficacia en este estudio serán la mejora en la capacidad de mantener la erección en hombres con DE y la mejora de la calidad de la vida sexual de su pareja femenina al finalizar 12 semanas de tratamiento aleatorio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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 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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    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) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Information not present in EudraCT
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    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 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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 308
    F.4.2.2In the whole clinical trial 308
    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 Decision2006-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-03
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