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    Summary
    EudraCT Number:2008-005744-17
    Sponsor's Protocol Code Number:ENDOMET-IA-DIULNG08
    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:2008-11-07
    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 number2008-005744-17
    A.3Full title of the trial
    INHIBIDORES DE LA AROMATASA (ANASTROZOL) ASOCIADOS A DISPOSITIVO INTRAUTERINO LIBERADOR DE LEVONORGESTREL (DIU-LNG) EN EL TRATAMIENTO DE LA ENDOMETRIOSIS MODERADA/SEVERA
    A.4.1Sponsor's protocol code numberENDOMET-IA-DIULNG08
    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 SponsorPEDRO ACIEN ALVAREZ
    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 Information not present in EudraCT
    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 nameARIMIDEX
    D.3.2Product code 61286
    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 INNANASTROZOL
    D.3.9.3Other descriptive nameANASTROZOLE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 Yes
    D.2.1.1.1Trade name MIRENA 20 microgramos/24 horas, sistema de liberación intrauterino
    D.2.1.1.2Name of the Marketing Authorisation holderQUIMICA FARMACEUTICA BAYER, S.L.
    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.3.4Pharmaceutical form Intrauterine delivery system
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntrauterine use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVONORGESTREL
    D.3.9.1CAS number 797-63-7
    D.3.9.3Other descriptive nameLEVONORGESTREL
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ENDOMETRIOSIS MODERADA/SEVERA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10014778
    E.1.2Term Endometriosis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10014784
    E.1.2Term Endometriosis of ovary
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10014788
    E.1.2Term Endometriosis related pain
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10014785
    E.1.2Term Endometriosis of pelvic peritoneum
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level PT
    E.1.2Classification code 10014778
    E.1.2Term Endometriosis
    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: Valorar la eficacia de los inhibidores de la aromatasa (anastrozol) asociados a DIU de LNG
    para el tratamiento médico de la endometriosis moderada/severa y de sus síntomas, con o sin cirugía
    conservadora. Se valorarán: 1) Reducción o desaparición de los síntomas relacionados con la endometriosis y
    recogidos en la escala analógico-visual. 2) Reducción o desaparición de endometriomas y nódulos del tabique
    recto vaginal. 3) Normalización de los valores de CA-125
    E.2.2Secondary objectives of the trial
    Objetivos secundarios: 1) Disminución o desaparición de las recurrencias valoradas por los síntomas recogidos
    en la escala analógico-visual, por los hallazgos en la exploración (tacto) y ecografía transvaginal, y por la
    analítica (CA-125)
    2) Valoración de la eficacia de la simple punción aspiración ecoguiada bajo el efecto de Anastrozol y/o DIU de
    LNG frente a la cirugía conservadora.
    3) Consecución posterior de embarazo en las mujeres que así lo deseen.
    4) Necesidad de analgesia adicional con AINES y posible efecto beneficioso de los mismos sobre la
    endometriosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Pacientes con endometriosis confirmada en cirugía previa mediante estudio histopatológico, pero que ahora
    presentan persistencia o recurrencia de los síntomas de la endometriosis valorados por la Escala analógico visual
    (EAV >4), exploración rectal-vaginal mostrando nódulos en el tabique recto-vaginal y/o CA-125 elevado o en
    ascenso, pero que no presentan nuevos endometriomas que aconsejen reintervención. Además, no están
    buscando o no desean embarazo de momento y si aceptan la inserción de DIU de LNG durante 6 meses Y
    2) Mujeres con clínica (EAV > 4), analítica (CA-125 > 35) y ecografía transvaginal sugerente de
    endometriomas (> 3-4 cms en uno o ambos ovarios) en las que se plantee cirugía conservadora laparoscópica o
    laparotómica, que de momento no están buscando o no desean embarazo tras la cirugía y que aceptan la
    inserción de DIU de LNG durante 6 meses
    E.4Principal exclusion criteria
    Embarazo.
    Esterilidad con deseo y búsqueda actual de embarazo
    No relaciones sexuales previas y/o no aceptación de inserción de DIU de LNG
    Enfermedad inflamatoria pelviana aguda o recurrente o infección del tracto genital inferior.
    Malformaciones uterinas y/o miomas que distorsionen la cavidad endometrial.
    Presencia de cualquier patología médica que contraindique (o pudiese empeorar) con la toma de anastrozol y/o
    con el DIU de LNG, así como con las medicaciones adicionales Calcio D o Naproxeno.
    E.5 End points
    E.5.1Primary end point(s)
    1. Exploración y analítica general descartando otras enfermedades o patologías asociadas.
    2. Exploración ginecólogica y mamaria (espéculo, tacto vaginal/rectal)
    3. Ecografia transvaginal y Doppler: valoración de útero y anejos, tanto desde el punto de vista funcional como
    patológico.
    4. Analítica: FSH, LH, estradiol, PRL, progesterona, V.S.G, y CA-125, en la segunda mitad del ciclo.
    5. Valoración de síntomas con nuestra escala analógico-visual para endometriosis y cumplimentación del
    cuestionario de síntomas eventualmente relacionados.
    Controles posteriores:
    a) Ecográficos transvaginales: características y medidas de endometriomas, estudio Doppler. Controles
    ecográficos de folículos ováricos y endometrio
    b) Determinaciones de FSH, LH, estradiol, PRL y progesterona. VSG y CA-125
    c) Escala analógico visual de la endometriosis y cuestionario de síntomas
    Medida principal de eficacia:
    1) Reducción o desaparición de los síntomas relacionados con la endometriosis y recogidos en la escala
    analógico-visual.
    2) Reducción o desaparición de endometriomas y nódulos del tabique recto-vaginal.
    3) Normalización de los valores de CA-125
    Por comparación entre los valores pretratamiento, durante el tratamiento y a los 3 meses de finalizar, en la
    segunda mitad del ciclo.
    Medidas secundarias:
    1) Disminución o desaparición de las recurrencias valoradas por los síntomas recogidos en la escala analógicovisual,
    por los hallazgos en la exploración (tacto) y ecografía transvaginal, y por la analítica (CA-125), en el
    seguimiento a 6 meses y anual postratamiento
    2) Valoración de la eficacia de la simple punción aspiración ecoguiada bajo el efecto de Anastrozol y/o DIU de
    LNG frente a la cirugía conservadora.
    2) Consecución posterior de embarazo en las mujeres que así lo deseen.
    3) Necesidad de analgesia adicional con AINES y posible efecto beneficioso de los mismos sobre la
    endometriosis.
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    A LOS 12 MESES DE INICIAR EL TRATAMIENTO EL ULTIMO SUJETO
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days1
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-11-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state80
    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)
    REVISION A LOS 6 MESES Y LUEGO ANUAL
    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 Decision2008-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-26
    P. End of Trial
    P.End of Trial StatusOngoing
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