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    Summary
    EudraCT Number:2007-006700-37
    Sponsor's Protocol Code Number:CAVISEX
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-02-01
    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 number2007-006700-37
    A.3Full title of the trial
    Cambios en la calidad de vida sexual en pacientes con disfunción eréctil tratados con vardenafilo tras una respuesta parcial a sildenafilo o tadalafilo
    A.4.1Sponsor's protocol code numberCAVISEX
    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 SponsorInstituto Andaluz de Sexología
    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 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-51368, Leverkusen, Alemania
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNvardenalfil
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10mg y 20mg
    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
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la proporción de pacientes con disfunción eréctil que recuperan su calidad de vida sexual previa, valorada con el cuestionario m-SLQQ-QoL, al recibir tratamiento con vardenafilo después de una respuesta parcial a sildenafilo o a tadalafilo.
    E.2.2Secondary objectives of the trial
    Evaluar los cambios en calidad de vida sexual, valorada con m-SLQQ, en pacientes con disfunción eréctil tratados con vardenafilo después de respuesta parcial a sildenafilo o a tadalafilo.
    Evaluar cambios en la función eréctil, valorada con IIEF-FE, en pacientes con disfunción eréctil tratados con vardenafilo después de respuesta parcial a sildenafilo o a tadalafilo.
    Explorar los factores predictores de respuesta a vardenafilo en pacientes con disfunción eréctil después de respuesta parcial a sildenafilo o a tadalafilo.
    Explorar posibles diferencias en la respuesta a vardenafilo de pacientes con disfunción eréctil y respuesta parcial a un i-PDE5 previo, en función de: tipo de i-PDE5 previo administrado, tiempo de tratamiento con el i-PDE previo administrado, severidad de la DE previa al primer tratamiento, las comorbilidades del paciente
    Describir la seguridad del tratamiento con vardenafilo en pacientes con disfunción eréctil y respuesta parcial previa a sildenafilo o a tadalafilo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    BRAZO 1:
    1. Varón >= 18 años de edad
    2. Varón en tratamiento para la DE con sildenafilo al menos durante un mes, con una puntuación del IIEF-FE >11<= 25
    3. Capaz de comprender la información sobre el estudio ofrecida y que haya firmado y fechado el consentimiento informado tras una evaluación completa tanto de la naturaleza del estudio como de sus riesgos y beneficios
    4. Capaz de tragar la medicación de estudio según el protocolo.
    BRAZO 2:
    1. Varón >= 18 años de edad
    2. Varón en tratamiento para la DE con tadalafilo al menos durante un mes, con una puntuación del IIEF-FE > 11 <= 25
    3. Capaz de comprender la información sobre el estudio ofrecida y que haya firmado y fechado el consentimiento informado tras una evaluación completa tanto de la naturaleza del estudio como de sus riesgos y beneficios
    4. Capaz de tragar la medicación de estudio según el protocolo.
    E.4Principal exclusion criteria
    1. Sujetos que toman nitratos o dadores de óxido nítrico
    2. No respondedores a sildenafilo y a tadalafilo (IIEF-FE < 11)
    3. Pacientes que reciben alfa bloqueadores
    4. Sujetos que toman los siguientes potentes inhibidores del citocromo P450 3A4: inhibidores de proteasa del VIH como ritonavir o indinavir, los agentes antimicóticos itraconazol y ketoconazol (las presentaciones típicas se degluten) o eritromicina o claritromicina.
    5. Cualquier trastorno médico inestable, psiquiátrico o de drogadicción que, a juicio del investigador, pueda afectar a la capacidad del sujeto de finalizar el estudio.
    6. Pérdida de visión en un ojo debida a una neuropatía óptica isquémica anterior no arterítica (NOIANA)
    7. Trastornos retinianos degenerativos hereditarios como la retinitis pigmentosa
    8. Cualquier trastorno cardiovascular grave como la angina de pecho inestable
    9. Antecedente de infarto de miocardio, ictus o arritmia amenazadora de la vida durante los 6 meses anteriores.
    10. Fibrilación/aleteo auricular descontrolado en el estudio sistemático (ritmo de respuesta ventricular ≥ 100 lpm).
    11. Hipotensión de 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).
    12. Hipotensión postural sintomática en los 6 meses anteriores a la visita 1
    13. Antecedente de prueba positiva al antígeno superficial de la hepatitis B (HBsAg) o a la hepatitis C.
    14. Úlcera péptica activa significativa.
    15. Hepatopatía grave aguda o crónica, antecedente de alteración hepática moderada (Child-Pugh B) o grave (Child-Pugh C).
    16. Enfermedad hematológica crónica clínicamente significativa que puede conducir a priapismo, como la drepanocitosis, el mieloma múltiple y la leucemia.
    17. Antecedente de neoplasia de cualquier sistema orgánico, tratada o no, en los últimos 5 años, existan o no indicios de recurrencia local o metástasis, excepto el carcinoma localizado de células basales de la piel.
    18. Trastorno hemorrágico.
    19. ALT o AST > 3 x límite superior de la normalidad
    20. Creatinina sérica > 3,0 mg/dl
    21. Aclaramiento de la creatinina sérica (calculado) < 30,0 mg/ml
    22. Sujetos que, a juicio del investigador, no cumplirán con el programa de visitas de los procedimientos de estudio.
    23. Pacientes iletrados o incapaces de comprender los cuestionarios o que no están preparados para cumplimentar el diario del paciente.
    24. Antecedente, en los 6 últimos meses, de migrañas intensas con una frecuencia igual o superior a una al mes.
    25. Sujetos no dispuestos a abstenerse del consumo de zumo de pomelo o de productos que contengan zumo de pomelo con la medicación de estudio.
    26. Pacientes que han recibido cualquier fármaco de investigación (incluyendo el placebo) en los 30 días anteriores a la visita inicial V0.
    27. Sujetos con hipersensibilidad conocida a vardenafilo, BAY 38-9456 (también conocido como SB-782528) o a cualquier componente de la medicación de investigación
    E.5 End points
    E.5.1Primary end point(s)
    Facilidad de penetración, valorada mediante el Sexual Life Quality Questionnaire (SLQQ-QOL, ítem 3).
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned60
    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 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 years0
    E.8.9.1In the Member State concerned months11
    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 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2387
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 2387
    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 Decision2008-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-04
    P. End of Trial
    P.End of Trial StatusOngoing
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