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    Summary
    EudraCT Number:2013-002979-17
    Sponsor's Protocol Code Number:MANCOR
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-11-12
    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 number2013-002979-17
    A.3Full title of the trial
    Comparative study between the usage of corifollitropin alfa and daily recombinant FSH in the ovarian stimulation of low responders
    Estudio comparativo entre el uso de corifolitropina alfa y FSH recombinante diaria en estimulación ovárica de pacientes con baja respuesta
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparative study between the usage of corifollitropin alfa and daily recombinant FSH in the ovarian stimulation of low responders
    Estudio comparativo entre el uso de corifolitropina alfa y FSH recombinante diaria en estimulación ovárica de pacientes con baja respuesta
    A.4.1Sponsor's protocol code numberMANCOR
    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 Sevilla
    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
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIVI Sevilla
    B.5.2Functional name of contact pointResearch associate
    B.5.3 Address:
    B.5.3.1Street AddressAvenida República Argentina 58
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41011
    B.5.3.4CountrySpain
    B.5.4Telephone number+34954286274
    B.5.5Fax number+34954285084
    B.5.6E-mailvictor.blasco@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 Elonva
    D.2.1.1.2Name of the Marketing Authorisation holderN.V. Organon, Kloosterstraat 6, 5349 AB Oss, Países Bajos
    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 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.3.9.4EV 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 Puregon
    D.2.1.1.2Name of the Marketing Authorisation holderN.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, Netherlands
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFOLLICLE-STIMULATING HORMONE
    D.3.9.1CAS number 9002-68-0
    D.3.9.3Other descriptive nameFOLLICLE-STIMULATING HORMONE
    D.3.9.4EV Substance CodeSUB25237
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number225 to 300
    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: 3
    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 Menopur
    D.2.1.1.2Name of the Marketing Authorisation holderFerring, S.A.U. C/ Gobelas, nº 11 28023 Madrid (España)
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN MENOPAUSAL GONADOTROPHINS
    D.3.9.1CAS number 61489-71-2
    D.3.9.3Other descriptive nameHUMAN MENOPAUSAL GONADOTROPHINS
    D.3.9.4EV Substance CodeSUB22171
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    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
    Low response to ovarian stimulation
    Baja respuesta a la estimulación ovárica
    E.1.1.1Medical condition in easily understood language
    Low response to ovarian stimulation
    Baja respuesta a la estimulación ovárica
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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
    To evaluate the effect on the number of mature oocytes obtained after the follicular puncture depending on the stimulation protocol applied:
    -Stimulation protocol A (experimental): controlled ovarian stimulation using corifollitropin alfa
    -Stimulation protocol B (control): controlled ovarian stimulation using recombinant FSH and highly purified HMG
    Evaluar el efecto en el número de ovocitos maduros que se recuperan tras la punción folicular en función del protocolo de estimulación aplicado:
    - Patrón de estimulación A (experimental): estimulación ovárica controlada con corifolitropina alfa.
    - Patrón de estimulación B (control): estimulación ovárica controlada con FSH recombinante y HMG ultrapurificada.
    E.2.2Secondary objectives of the trial
    To evaluate the following parameters depending on the stimulation protocol applied (stimulation protocol A vs stimulation protocol B):
    - Total number of oocytes obtained after the follicular puncture
    - Number of stimulation days
    - Number of subcutaneous injection days
    - Total gonadotropin doses
    - Symptomatology
    - Patient perception of the stimulation treatment
    Evaluar los siguientes parámetros en función del patrón de estimulación aplicado (patrón de estimulación A frente a patrón de estimulación B):
    - Número de ovocitos totales recuperados tras la punción
    - Días de estimulación
    - Días de inyecciones subcutáneas
    - Dosis totales de gonadotropinas
    - Sintomatología
    - Percepción del tratamiento de estimulación por parte de la paciente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be included in this trial when:
    -They must go through at least two stimulation cycles.
    -They are low responders to ovarian stimulation according to the Bologna criteria.
    -They accept voluntarily to participate in the trial signing an informed consent form.
    According to the Bologna criteria, at least two of the following three features must be present to be considered low responder:
    (i) Advanced maternal age (?40 years) or any other risk factor for poor response;
    (ii) A previous poor response (?3 oocytes with a conventional stimulation protocol);
    (iii) An abnormal ovarian reserve test (i.e. Antral Follicular Count 5?7 < follicles or Anti-Mullerian Hormone value < 0.5?1.1 ng/ml).
    Serán incluidas en el estudio aquellas pacientes que:
    -Vayan a someterse a un mínimo de dos ciclos de estimulación.
    -Sean bajas respondedoras de acuerdo a los criterios de Bolonia.
    -Acepten voluntariamente participar en el estudio, firmando el consentimiento informado.
    Según los criterios de Bolonia, al menos dos de las siguientes características deben estar presentes en una paciente para ser considerada baja respondedora:

    ?Edad materna avanzada (? 40 años en el momento de la firma del consentimiento) o cualquier otro factor de riesgo para ser baja respondedora
    ?Baja respuesta previa (? 3 ovocitos con un protocolo de estimulación convencional).
    ?Test de reserva ovárica con resultados anormales: recuento de folículos antrales (AFC) < 5-7 folículos; o concentración de hormona antimulleriana (AMH) en sangre < 0.5-1.1 ng/ml).
    E.4Principal exclusion criteria
    -Not fullfilling the inclusion criteria.
    -Not being able to sign the informed consent form.
    -No cumplir alguno de los criterios de inclusión.
    -No estar en condiciones de firmar el consentimiento informado aceptando la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Number of mature oocytes obtained after the follicular puncture
    Número de ovocitos maduros obtenidos tras la punción folicular
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be recruited for a year (from September 2013 to September 2014).
    Se reclutarán pacientes durante un año (de Septiembre de 2013 a Septiembre de 2014).
    E.5.2Secondary end point(s)
    -Total number of oocytes obtained after the follicular puncture
    -Number of stimulation days
    -Number of subcutaneous injection days
    -Total gonadotropin doses
    -Symptomatology
    -Patient perception of the estimulation protocol
    -Número de ovocitos totales recuperados tras la punción folicular
    -Días de estimulación ovárica controlada
    -Días de inyecciones subcutáneas de gonadotropinas para la estimulación ovárica
    -Dosis totales de gonadotropinas inyectadas
    -Sintomatología
    -Percepción del tratamiento de estimulación por parte de la paciente
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be recruited for a year (from September 2013 to September 2014).
    Se reclutarán pacientes durante un año (de Septiembre de 2013 a Septiembre de 2014).
    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 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 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 Yes
    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 concerned4
    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
    LVLS
    Última visita del último sujeto.
    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 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 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: 60
    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 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 state60
    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 Decision2014-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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