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    Summary
    EudraCT Number:2018-003484-56
    Sponsor's Protocol Code Number:BOLDOS-18
    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:2019-07-26
    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 number2018-003484-56
    A.3Full title of the trial
    Efficacy of corifolitropin alfa in double ovarian stimulation compared with two conventional ovarian stimulation cycles for embryo accmulation in low responder patients. Multicenter randomized controlled trial with non-inferiority comparison.
    Eficacia de corifolitropina alfa en doble estimulación frente a doble estimulación ovárica convencional con destino a acumulación embrionaria en pacientes con perfil de baja respondedora. Estudio multicéntrico aleatorizado y abierto de no inferioridad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Corifolitropin alfa for double ovarian stimulation in low responders
    Corifolitropina alfa para doble estimulación en bajas respondedoras
    A.3.2Name or abbreviated title of the trial where available
    BOLDOS-18 (Bologna Criteria patients treated with Dual Ovarian Stimulation)
    BOLDOS-18
    A.4.1Sponsor's protocol code numberBOLDOS-18
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMiguel Caballero Campo
    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 supportNone
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital General Universitario Gregorio Marañón
    B.5.2Functional name of contact pointSección de Reproducción Asistida
    B.5.3 Address:
    B.5.3.1Street AddressC/ Dr. Esquerdo 46
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.4Telephone number34915290047
    B.5.5Fax number34915290414
    B.5.6E-mailmiguel.caballero@salud.madrid.org
    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 ELONVA 150 microgramos solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCORIFOLLITROPIN ALFA
    D.3.9.1CAS number 195962-23-3
    D.3.9.2Current sponsor codeOrg 36286
    D.3.9.3Other descriptive nameCORIFOLLITROPIN ALFA
    D.3.9.4EV Substance CodeSUB01455MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 ELONVA 150 microgramos solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCORIFOLLITROPIN ALFA
    D.3.9.1CAS number 195962-23-3
    D.3.9.2Current sponsor codeOrg 36286
    D.3.9.3Other descriptive nameCORIFOLLITROPIN ALFA
    D.3.9.4EV Substance CodeSUB01455MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    Infertility in patients requiring in vitro fertilization treatment with poor ovarian response profile, defined by Bologna Criteria.
    Infertilidad en pacientes tributarias de tratamiento con fecundación in vitro y con perfil de baja respuesta a la estimulación definido según Criterios de Bolonia.
    E.1.1.1Medical condition in easily understood language
    Low ovarian reserve in infertile patients
    Baja reserva funcional ovárica asociada a infertilidad
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10021926
    E.1.2Term Infertility
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate non-inferiority of a double ovarian stimulation using two sucessive doses of corifolltropin alfa (150 micrograms) versus two conventional controlled ovarian hyperstimulation cycles, in poor-responder patients defined according to Bologna Criteria, in terms of total number of oocytes obtained.
    Evaluar la no inferioridad de la doble estimulación mediante corifolitropina alfa (dos dosis de 150 μg) frente a dos ciclos sucesivos de estimulación ovárica convencional en pacientes con perfil de baja respuesta ovárica definido según Criterios de Bolonia y en términos de número de ovocitos obtenidos.
    E.2.2Secondary objectives of the trial
    a) Evaluate non-inferiority of accumulative clinical pregnancy rate and live birth rate, as well as other secondary efficacy outcomes (duration of stimulation, total dose of gonafotropins, serum estradiol on HCG day, number of total and MII oocytes, number of fertilized oocytes, normal fertilization rate, number of cleaving embryos, number of total and top quality embryos, clinical pregnancy rate per randomized patient and per embryo transfer).
    b) Compare, with exploratory intention, safety, and tolerability outcomes as cancellation rate due to low or excessive response, oocyte atresia after ICSI, abnormal oocoye fertilization, total or partial fertilization failure, number of non-survival thawed embryos, number of post-thawed non-developing embryos, miscarriage after weeks of pregnancy, adverse reactions rate.
    b) Comparative cost-efectiveness analysis
    c) Comparative analysis of psyco-emotional effects of stimulation treatments
    a) Evaluar exploratoriamente la no inferioridad de la frecuencia de gestación acumulada a término y de otras variables de eficacia (duración de la estimulación, dosis total de actividad FSH , estradiol sérico final, número de ovocitos totales y maduros, número de ovocitos fecundados, frecuencia de fecundación normal, número de embriones evolutivos totales y de alta calidad, frecuencia de gestación por paciente aleatorizada y por transferencia embrionaria).
    b) Comparar exploratoriamente frecuencias de cancelación por respuesta insuficiente o por hiperrespuesta, atresia ovocitaria tras ICSI, fecundación anormal, fallo total o parcial de fecundación, no supervivencia o no evolutividad embrionaria tras desvitrificación, aborto previo a la 12 semana y porcentaje de reacciones adversas).
    c) Realizar análisis coste-efectividad comparando las estrategias de estimulación
    d) Realizar análisis comparativo del impacto emocional
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Infertility requiring IVF/ICSI treatment
    b) Patients aged 36-41
    c) Body weight ≥ 50 kg
    d) Body Mass Index between 18.5 and 34.9 kg/m2
    e) Menstrual cycles during previous four months lasting between 21 and 35 days
    f) At least two of the following three features present:
    - Previous poor ovarian reserve (less than 3 recovered oocytes)
    - Antral follicular count (AFC) lower than 7 and/or antiMüllerian hormone (AMH) less than 1.1 ng/mL
    - Any other risk factor for low ovarian response
    g) Signing of the informed consent
    a) Infertilidad subsidiaria de tratamiento con FIV-ICSI
    b) Edad entre 36 y 41 años
    c) Peso corporal superior a 50 kg
    d) Índice de masa corporal comprendido entre 18,5 y 34,9 kg/m2
    e) Ciclos menstruales regulares durante los últimos cuatro meses de duración comprendida entre 21 y 35 días
    f) Presencia de al menos uno de los siguientes criterios de riesgo para baja respuesta a la estimulación ovárica:
    - Ciclo previo con menos de 3 ovocitos recuperados
    - Recuento de folículos antrales menor de 7 y/o hormona Antimülleriana (AMH) menor de 1,1 ng/mL
    - Presencia de otro factor de riesgo de baja reserva ovárica (endometriosis, cirugía ovárica, etc)
    g) Firma del consentimiento informado
    E.4Principal exclusion criteria
    a) Age, body weight, Body Mass Index or menstrual cycles duration out of inclusion range
    b) Extreme male factor, defined as severe oligozoospermia (< 1.000.000/mL), cryptozoospermia or use of non-ejaculate spermatozoa
    c) Contraindications for IVF/ICSI or pregnancy
    d) Contraindications for use of IMP specified by EMA technical file:
    - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
    - Tumours of the ovary, breast, uterus, pituitary or hypothalamus
    - Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause
    - Primary ovarian failure
    - Ovarian cysts or enlarged ovaries
    - A history of Ovarian Hyperstimulation Syndrome (OHSS)
    - A previous COS cycle that resulted in more than 30 follicles > 11 mm measured by ultrasound examination
    - A basal antral follicle count > 20
    - Fibroid tumours of the uterus incompatible with pregnancy
    - Malformations of the reproductive organs incompatible with pregnancy
    - Polycystic ovarian syndrome (PCOS)
    e) Contraindications for use of any other drug applied in this protocol
    f) Other uterine or tubal disorders that, in investigator's opinion, might cause relevant reduction of clinical pregancy and live birth rates
    a) Edad, peso corporal o índice de masa corporal o duración de los ciclos menstruales fuera del rango definido en los criterios de inclusión
    b) Factor masculino grave, definido oligoospermia grave (< 1 millón de espermatozoides/mL), criptozoospermia o necesidad de microinyección de espermatozoides no procedentes del eyaculado (testiculares o epididimarios).
    c) Contraindicaciones para el tratamiento con fecundación in vitro-microinyección espermática, o para la gestación
    d) Contraindicaciones para el tratamiento con el fármaco en estudio establecidas en su ficha técnica en vigor:
    - Hipersensibilidad al principio activo o a alguno de los excipientes.
    - Tumores ováricos, de la mama, útero, hipófisis o hipotálamo.
    - Hemorragia vaginal anormal (no menstrual) sin causa conocida/diagnosticada.
    - Insuficiencia ovárica primaria, definida como presencia de al menos dos determinaciones de FSH sérica superiores a 40 UI/L en el contexto de una amenorrea secundaria de duración no inferior a tres meses
    - Quistes ováricos o aumento del tamaño de los ovarios
    - Historia de Síndrome de Hiperestimulación Ovárica
    - Ciclo previo de Estimulación Ovárica Controlada con resultado de más de 20 folículos > 11 mm medidos por ecografía
    - Recuento basal de folículos antrales superior a 20
    - Miomas uterinos incompatibles con el embarazo
    - Malformaciones de los órganos sexuales incompatibles con el embarazo
    - Síndrome de ovario poliquístico
    e) Contraindicaciones para el tratamiento con el resto de los fármacos incluidos en el protocolo y en los términos establecidos por éste
    f) Presencia de otras patologías uterinas o tubáricas que a juicio del investigador determine una reducción relevante de la probabilidad de gestación y nacido vivo.
    E.5 End points
    E.5.1Primary end point(s)
    Number of total retrieved oocytes
    Número de ovocitos totales obtenidos
    E.5.1.1Timepoint(s) of evaluation of this end point
    The main timepoint of evaluation will be embryo transfer phase of treatment. If embryo transfer is not reached as a result of any of the following causes, respective timepoints of evaluation will be:
    a) After cancelation of second stimulation, if this event occurs
    b) After second oocyte retrieval, if no oocytes are recovered
    c) After confirming absence of fertilization or abnormal fertilization in all recovered oocytes
    d) After confirming divisional arrest of all available embryos.
    El momento principal de evaluación de las variables primarias de resultado será la fase de transferencia embrionaria. Si ésta no se alcanzase por alguno de los siguientes motivos, los momentos de evaluación de las variables primarias serían, respectivamente:
    a) Tras la cancelación de la segunda estimulación, si este evento se produce
    b) Tras la segunda punción folicular, en caso de que no se obtengan ovocitos
    c) Tras la confirmación de la ausencia de fecundación o de fecundación normal
    d) Tras la confirmación de detención del desarrollo de todos los embriones disponibles.
    E.5.2Secondary end point(s)
    Effectiveness secondary end points:
    - Duration of ovarian stimulation
    - Aditional gonadotropin consumption
    - Serum oestradiol on triptorelin/hCG day
    - Number of follicles > 15 mm and > 17 mm
    - Cancelation rate (due to insufficient ovarian response)
    - Number of metaphase II oocytes
    - Number of total and metaphase II oocytes obtained in first and second stimulation
    - Number of normally fertilized oocytes
    - Normal fertilization rate
    - Endometrial thickness on triptorelin/HCG administration day
    - Cumulative number of developing embryos grade A or B in +2 or +3 days, obtained from first stimulation
    - Cumulative number of developing embryos grade A or B in +2 or +3 days, obtained from second stimulation
    - Cumulative number of developing embryos grade C or D in +2 or +3 days, obtained from first stimulation
    - Cumulative number of developing embryos grade C or D in +2 or +3 days, obtained from second stimulation
    - Cumulative number of developing embryos grade A or B in +5 or +6 days, obtained from first stimulation
    - Cumulative number of developing embryos grade A or B in +5 or +6 days, obtained from second stimulation
    - Cumulative number of developing embryos grade C or D in +5 or +6 days, obtained from first stimulation
    - Cumulative number of developing embryos grade C or D in +5 or +6 days, obtained from second stimulation
    - Number of surviing embryos after devitrification
    - Endometrial thickness on cryotransfer scheduling
    - Implantation rate per fresh embryo transfer or freezed-thawed embryo transfer
    - Clinical pregnancy rate per fresh embryo transfer or freezed-thawed embryo transfer
    - Ongoing pregnancy rate per fresh embryo transfer or freezed-thawed embryo transfer
    - Cumulative clinical pregnancy rate per patient
    - Cumulative ongoing pregnancy rate per patient
    - Cumulative live birth rate per patient
    - Time to pregnancy
    - Frequency of patients with remaining embryos after geting live birth

    Safety and tolerability secondary endpoints
    - Multiple pregnancy rate per fresh or thawed embryo transfer
    - Cumulative multiple pregnancy rate per patient
    - Hyperstimulation ovarian syndrome rate
    - Miscarriage rate per embryo transfer
    - Ectopic pregnancy rate per embryo transfer
    - Miscarriage rate per patient
    - Ectopic pregnancy rate per patient
    - Local adverse reactions rate
    g) Drop-out frequency
    h) STAI-S & STA-T Scale score on T2 to T6
    i) PPS Scale score on T2 to T6
    j) ISES Scale score on T2 to T6

    Cost-effectiveness secondary outcomes:
    - Incremental Cost
    - Incremental effectivity
    Variables de efectividad:
    - Duración de la estimulación ovárica
    - Consumo de gonadotropinas adicionales
    - Estradiol sérico en día de administración de triptorelina/HCG
    - Número folículos >17 mm y >15 mm en día de administración de triptorelina/HCG
    - Frecuencia de cancelación de la estimulación por respuesta insuficiente
    - Número de ovocitos en metafase II
    - Número de ovocitos totales y en metafase II obtenidos en primera y segunda estimulación
    - Número de ovocitos con fecundación normal
    - Frecuencia de fecundación normal
    - Espesor endometrial en el día de administración de triptorelina/HCG
    - Número acumulado de embriones evolutivos obtenidos con calidad A o B en día +2 o +3 de desarrollo y procedentes de estimulación en fase folicular.
    - Número acumulado de embriones evolutivos obtenidos con calidad A o B en día +2 o +3 de desarrollo y procedentes de segunda estimulación
    - Número acumulado de embriones evolutivos obtenidos con calidad C o D en día +2 o +3 de desarrollo y procedentes de estimulación en fase folicular
    - Número acumulado de embriones evolutivos obtenidos con calidad C o D en día +2 o +3 de desarrollo y procedentes de la segunda estimulación
    - Número acumulado de embriones evolutivos obtenidos con calidad A o B en día +5 o +6 de desarrollo y procedentes de estimulación en fase folicular
    - Número acumulado de embriones evolutivos obtenidos con calidad A o B en día +5 o +6 de desarrollo y procedentes de segunda estimulación
    - Número acumulado de embriones evolutivos obtenidos con calidad C o D en día +5 o +6 de desarrollo y procedentes de estimulación en fase folicular
    - Número acumulado de embriones evolutivos obtenidos con calidad C o D en día +5 o +6 de desarrollo y procedentes de segunda estimulación
    - Número de embriones que sobreviven a la desvitrificación
    - Espesor endometrial en el día de indicación de la criotransferencia
    - Frecuencia de supervivencia a la desvitrificación
    - Frecuencia de implantación por transferencia en fresco o tras desvitrificación
    - Frecuencia de gestación clínica por transferencia en fresco o tras desvitrificación
    - Frecuencia de gestación evolutiva por transferencia en fresco o tras desvitrificación
    - Frecuencia acumulada de gestación clínica por paciente
    - Frecuencia acumulada de gestación evolutiva por paciente
    - Frecuencia acumulada de nacido vivo por paciente
    - Tiempo hasta la consecución de la gestación
    - Frecuencia de pacientes con embriones remanentes tras nacido vivo

    Variables de seguridad y tolerabilidad:
     Frecuencia de gestación múltiple por transferencia en fresco o tras desvitrificación
    - Frecuencia acumulada de gestación múltiple por paciente
    - Frecuencia de síndrome de hiperestimulación ovárica
    - Frecuencia de aborto por transferencia en fresco o tras desvitrificación
    - Frecuencia de gestación ectópica por en fresco o tras desvitrificación
    - Frecuencia acumulada de aborto por paciente
    - Frecuencia acumulada de gestación ectópica por paciente
    - Frecuencia de reacciones adversas locales
    - Frecuencia de abandono voluntario
    - Puntuación en el cuestionario STAI-S & STA-T en T2 a T6.
    - Puntuación en el cuestionario PPS en T2 a T6.
    - Puntuación en el cuestionario ISES en T2 a T6

    Variables de coste-efectividad:
    - Coste incremental
    - Efectividad incremental
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each one of secondary endpoints will be evaluated when appropiate:
    a) Duration of stimulation, gonadotropin conssumption, final serum estradiol: at the end of ovarian stimulation
    b) Number, quality and viability of oocytes and embryos: pick-up, fertilization and embryo culture and embryo transfer phases.
    c) Pregnancy and miscarriage outcomes: 14 days after embryo transfer, 6th to 10th pregnancy week, term of pregnancy and at the end of observation period.
    d) Hyperstimulation syndrome and adverse reactions: ovarian stimulation period, 10th day after triggering, 6th to 8th pregnancy weeks, term of pregnancy and at the end of observation period
    e) STAI-S, STAI-T, PPS and ISES Scales scores: on T2 to T6 days.
    f) Incremental cost ratio: at the end of observation period
    Cada una de las variables secundarias será evaluada en la fase del estudio procedente:
    a) Duración de la estimulación, consumo de gonadotropinas, estradiol final´: al final de la estimulación.
    b) Número, calidad y viabilidad de ovocitos y embriones: fases de punición folicular, fecundación, embrionario y transferencia embrionaria.
    c) Resultados gestacionales: 14º día postransferencia, 6º y 10ª semana de gestación, final del la gestación y cierre del estudio.
    d) Síndrome de hiperestimulación ovárica y reacciones adversas: fase de estimulación ovárica, semanas 6ª a 10ª de gestación, final de la gestación y cierre del estudio.
    e) Puntuaciones en escalas STAI-S, STAI-T, PPS and ISES Scales scores: en días T2 a T6.
    f) Ratio de coste incremental: cierre 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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned10
    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 No
    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
    Trial will end with the last visit of the last subject undergoing the trial
    El cierre del periodo de observación tendrá lugar cuando se produzca la última visita de seguimiento del último paciente reclutado.
    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 months
    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 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 292
    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 Yes
    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 state292
    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)
    None
    Ninguno
    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 Decision2019-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
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