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    Summary
    EudraCT Number:2007-003399-20
    Sponsor's Protocol Code Number:ITFE-2026C2
    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:2007-11-26
    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 number2007-003399-20
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, para determinar la eficacia y seguridad de una nueva formulación de estriol en baja concentración (ITFE-2026 0,005%) para aplicación vía vaginal en el tratamiento de la atrofia vaginal postmenopáusica
    A.4.1Sponsor's protocol code numberITFE-2026C2
    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 SponsorITALFARMACO S.A
    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 No
    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 nameESTRIOL GEL VAGINAL 0.005%
    D.3.4Pharmaceutical form Vaginal gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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 Yes
    D.3.11.13.1Other medicinal product typeANTIBIOTICO TRATADO QUIMICAMENTE
    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 placeboVaginal gel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ATROFIA VAGINAL
    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 EFICACIA DE ITFE-2026 0.005% MEDIANTE EL CAMBIO EN EL VALOR DE MADURACION (VM) TRAS 12 SEMANAS
    E.2.2Secondary objectives of the trial
    * DETERMINAR LA VARIACION DEL PH VAGINAL, ASI COMO DE LOS SINTOMAS Y SIGNOS SUGESTIVOS DE LA ATROFIA VAGINAL TRAS 12 SEMANAS DE TRATAMIENTO
    * ESTUDIAR LA VARIACION DEL VM, EL PH Y LOS SINTOMAS Y SIGNOS SUGESTIVOS DE LA ATROFIA VAGINAL TRAS UN PERIODO DE SEGUIMIENTO INICIAL DE 3 SEMANAS
    * EVALUAR LA SEGURIDAD DEL ESTRIOL GEL VAGINAL 0.005%
    * EVALUAR LA ACEPTABILIDAD DEL ESTRIOL GEL VAGINAL 0.005%
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Mujeres de cualquier edad.
    •Menopausia con un tiempo de amenorrea ≥ 2 años, bien por menopausia natural o menopausia quirúrgica (ooforectomía bilateral).
    •Presencia de síntomas y signos de atrofia de la mucosa vaginal, incluyendo como mínimo la sequedad vaginal como síntoma referido por la paciente, junto con al menos un signo de la enfermedad objetivado por el investigador.
    •Como síntomas, la paciente puede referir sequedad vaginal, prurito, quemazón, dispareunia, disuria o cualquier otro síntoma que el investigador considere relacionado con la presencia de atrofia vaginal.
    •Como signos, el investigador puede objetivar en el examen ginecológico con espéculo una mucosa vaginal adelgazada o con aplanamiento de pliegues, una mucosa vaginal pálida, seca, frágil, la presencia de petequias o cualquier otro signo que el investigador considere indicativo de la existencia de atrofia vaginal.
    •Pacientes con mamografía realizada en el período de un año previo a la inclusión en el estudio.
    •Pacientes con capacidad para comprender la naturaleza y propósito del estudio, cooperar con el investigador y cumplir con los requisitos del estudio.
    •Pacientes que otorguen el consentimiento informado por escrito para participar en el estudio.
    E.4Principal exclusion criteria
    •Pacientes con contraindicaciones para la terapia hormonal con estrógenos por presentar antecedentes de:
    •Lesiones malignas y premalignas de mama y endometrio.
    •Patología tumoral maligna de colon. Melanoma maligno
    •Patología tumoral hepática.
    •Trastornos tromoboembólicos venosos (trombosis venosa profunda, embolismo pulmonar) o arteriales (angina de pecho, infarto de miocardio, accidente cerebrovascular).
    •Coagulopatías.
    •Sangrado vaginal de etiología desconocida.
    •Pacientes que presenten valores de laboratorio anormales al inicio del estudio que el investigador juzgue como clínicamente relevantes para los propósitos del presente estudio.
    •Pacientes que presenten signos y síntomas sugestivos de infección del tracto genital o urinario al inicio del estudio.
    •Pacientes con cualquier patología médico-quirúrgica mal controlada en el momento de la inclusión en el estudio.
    •Pacientes con cualquier proceso agudo cuyo manejo o evolución el investigador considere puede interferir en el desarrollo del estudio.
    •Pacientes con grosor endometrial igual o superior a 4 mm medido por ecografía transvaginal
    •Pacientes con prolapso úterovaginal grado II o superior.
    •Pacientes que hayan recibido algún tipo de tratamiento vulvovaginal en los 15 días previos al inicio del estudio.
    •Pacientes que hayan recibido fitoestrógenos en el período de un mes previo al inicio del estudio, incluida la administración vía vaginal..
    •Pacientes que hayan recibido Terapia Hormonal en el período de 3 meses previos al inicio del estudio, incluida la administración de estrógenos por vía vaginal.
    •Pacientes en tratamiento con fármacos descritos en el apartado 7.3.
    •Pacientes que cuenten con historia de alergia a alguno de los componentes de la medicación en estudio (Veáse el apartado 3.3: Descripción de los productos en estudio).
    •Pacientes que hayan participado en la evaluación experimental de cualquier fármaco durante las 8 semanas anteriores al inicio del presente estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Cambio en el valor de maduración (VM) a las 12 semanas de tratamiento con respecto al valor basal
    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) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Information not present in EudraCT
    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 concerned11
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    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
    8
    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 months8
    E.8.9.1In the Member State concerned days
    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) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Information not present in EudraCT
    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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state165
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 165
    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 Decision2007-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-02-23
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