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    Summary
    EudraCT Number:2015-002214-77
    Sponsor's Protocol Code Number:1504-MAD-024-AR
    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:2015-09-11
    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 number2015-002214-77
    A.3Full title of the trial
    Prospective randomized clinical trial to test the efficacy of a biosimilar recombinant FSH (Bemfola) vs. urinary FSH (Fostipur) in an oocyte donation program
    Ensayo clínico prospectivo y aleatorio para comprobar la eficacia de un biosimilar de FSH recombinante (Bemfola) vs. FSH urinaria (Fostipur) en un programa de donación de ovocitos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparative analysis between recombinant FSH biosimilar vs. urinary FSH in a oocyte donation program
    Análisis comparativo entre biosimilar FSH recombinante vs. FSH urinaria en un programa de donación de ovocitos
    A.3.2Name or abbreviated title of the trial where available
    Bemfola vs. Fostipur
    Bemfola vs.Fostipur
    A.4.1Sponsor's protocol code number1504-MAD-024-AR
    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 SponsorIVI Madrid
    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 supportIVI Madrid
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIVI Msdrid
    B.5.2Functional name of contact pointIVI Madrid
    B.5.3 Address:
    B.5.3.1Street AddressAvda del Talgo 68-70
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28023
    B.5.3.4CountrySpain
    B.5.4Telephone number+34911802900
    B.5.5Fax number+34911802909
    B.5.6E-mailMaria.Cruz@ivi.es
    D. IMP Identification
    D.IMP: 1
    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 Fostipur
    D.2.1.1.2Name of the Marketing Authorisation holderAngelini Farmaceútica
    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 Powder and solvent for solution for injection in pre-filled pen
    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 INNUROFOLLITROPIN
    D.3.9.1CAS number 97048-13-0
    D.3.9.3Other descriptive nameUROFOLLITROPIN
    D.3.9.4EV Substance CodeSUB05053MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(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 No
    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 Bemfola
    D.2.1.1.2Name of the Marketing Authorisation holderFinox Biotech
    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 Suspension for injection in pre-filled pen
    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 INNFOLLITROPIN ALFA
    D.3.9.1CAS number 56832-30-5
    D.3.9.3Other descriptive nameFOLLITROPIN ALFA
    D.3.9.4EV Substance CodeSUB12426MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(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 No
    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
    The proposed study is to determine the efficacy of a recombinant FSH biosimilar vs. urinary FSH in oocyte donation program
    El estudio está planteado para determinar la eficacia de un biosimilar de la FSH recombinante vs. FSH urinarial en un programa de donación de ovocitos
    E.1.1.1Medical condition in easily understood language
    It is intended to determine the efficacy in terms of quality oocyte of a biosimilar recombinant FSH
    Se pretende determinar la eficacia en términos de calidad ovocitaria de un biosimilar de la FSH recombinante
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    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
    Non-inferiority study of a biosimilar of recombinant FSH regarding a conventional ovarian stimulation protocol with urinaryFSH compared to the number of oocytes retrieved and the number of
    metaphase II oocytes
    Estudio de no-inferioridad de un biosimilar de la FSH recombinante respecto a un protocolo de estimulación ovárica convencional con FSH urinaria en relación al número de ovocitos recuperados y a la cantidad de ovocitos metafase II
    E.2.2Secondary objectives of the trial
    - Comparative analysis of fertilization and implantation rates
    - Comparative analysis of the dropout rate andcycle cancellation rate
    - Analysis of drug-economic impact related with the administration of a biosimilar recombinant FSH vs. urinary FSH
    - Evaluation of oocyte quality parameters through the following analysis:
            - Analysis of serum hormone profile
            - Analysis of the rate of apoptosis in granulosa cells
            - Analysis of the kinetics of embryonic development
    - Análisis comparativo de las tasas de fecundación y tasas de implantación
    - Análisis comparativo de la tasa de abandono y de la tasa de cancelación del ciclo
    - Análisis del impacto fármaco-económico derivado de la administración de un biosimilar de la FSH recombinante vs. FSH urinaria
    - Evaluación de parámetros de calidad ovocitaria a través de los siguientes análisis:
    - Análisis del perfil hormonal en suero
    - Análisis de la tasa de apoptosis en células de la granulosa
    - Análisis de la cinética de desarrollo embrionario
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients aged 18-35 years who meet the criteria for entry into the program and IVI Donors are to receive gonadotropins.
    Pacientes entre 18-35 años que cumplan con los criterios de entrada en el Programa de Donantes del IVI y vayan a recibir gonadotropinas.
    E.4Principal exclusion criteria
    Those identified for Oocyte Donation Program in IVI
    - Patient with a basal antral count> 20 follicles in total or <6 antral follicles per ovary
    - Patients with comorbidities that, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation
    - The presence of ovarian cysts that judgment of the investigator would interfere with the stimulation or may pose a risk to the donor
    - BMI <18 kg / m2
    - BMI> 30 kg / m2
    - Severe hypersensitivity to drugs with similar structure
    Los identificados para el Programa de Donación de Ovocitos de IVI
    - Paciente con un recuento basal de folículos antrales >20 en total o <6 folículos antrales por ovario
    - Pacientes con patologías asociadas que, a juicio del investigador, puedan interferir en el tratamiento de estimulación ovárica
    - Presencia de quistes ováricos que a juicio del investigador puedan interferir en la estimulación o puedan representar un riesgo para la donante
    - IMC<18 kg/m2
    - IMC>30 kg/m2
    - Hipersensibilidad grave a medicamentos con estructura similar
    E.5 End points
    E.5.1Primary end point(s)
    Number of metaphase II oocytes and the percentage of apoptosis in cumulus cells obtained at each stimulation protocols
    La variable principal es el número de ovocitos metafase II y el porcentaje de apoptosis en células de la granulosa, obtenidos en cada uno de los protocolos de estimulación analizados.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A month
    1 mes
    E.5.2Secondary end point(s)
    - Mean length of treatment (average number of days of treatment)
    - Total dose of gonadotropin
    - Mean levels of estradiol (pg / ml)
    - Mean levels of progesterone (ng / ml)
    - Mean fertilization rate (zygote percentage relative to the number of oocytes inseminated / microinjected)
    Mean percentage of vitrified embryos
    - Mean implantation rate (number of bags relative to the number of embryos transferred)
    - Media cancellation rate per cycle started (percentage of cycles interrupted for lack of response after 8 days of treatment)
    - Average rate of ovarian hyperstimulation syndrome (percentage of participants diagnosed with SHO)
    - Half of adverse events.
    - Embryonic development kinetics parameters
    - Media de la duración del tratamiento (número medio de días de tratamiento)
    - Media de la dosis total de gonadotropinas
    - Niveles medios de estradiol (pg/ml)
    - Niveles medios de progesterona (ng/ml)
    - Media de la tasa de fecundación (porcentaje de zigotos en relación al número de ovocitos inseminados/microinyectados)
    Media del porcentaje de embriones vitrificados
    - Media de la tasa de implantación (número de sacos en relación al número de embriones transferidos)
    - Media de la tasa de cancelación por ciclo iniciado (porcentaje de ciclos interrumpidos por no existir respuesta tras 8 días de tratamiento)
    - Media de la tasa de síndrome de hiperestimulación ovárica (porcentaje de participantes con diagnóstico de SHO)
    - Media de acontecimientos adversos.
    - Variables cinéticas de desarrollo embrionario
    E.5.2.1Timepoint(s) of evaluation of this end point
    A month
    1 mes
    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 No
    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 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 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) 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 concerned2
    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
    The test will be terminated when each patient has completed the
    follow-up period, or by discontinuation by:
    - Completion of the assay protocol
    - Loss of tracking (inability to contact the patient)
    - Decision of the patient (specify reason)
    - Decision of the researcher (gynecologist or nurse)
    - Preventing adverse reaction by continuing the patient in the trial
    -Death
    El ensayo se dará por finalizado cuando cada paciente haya concluido el
    periodo de seguimiento, o bien por interrupción del mismo por:
    - Finalización del ensayo por protocolo
    - Pérdida de seguimiento (incapacidad de contactar con la paciente)
    - Decisión de la paciente (especificar el motivo)
    - Decisión del investigador (ginecólogo o personal de enfermería)
    - Por reacción adversa que impida la continuación de la paciente en
    el ensayo
    -Fallecimiento
    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
    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: 130
    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 Yes
    F.3.2Patients No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    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
    No aplica
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation IVI Bilbao
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-25
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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