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    The EU Clinical Trials Register currently displays   44235   clinical trials with a EudraCT protocol, of which   7336   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-001259-22
    Sponsor's Protocol Code Number:28613
    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:2008-07-18
    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 number2008-001259-22
    A.3Full title of the trial
    ?Ensayo clínico fase IV, prospectivo, multicéntrico, aleatorizado y abierto para evaluar la eficacia y seguridad de GONAL-f® a una dosis basada en las características iniciales de la paciente determinada mediante la calculadora CONSORT, en comparación con una dosis estándar diaria de 150 UI de GONAL-f® para la estimulación ovárica en mujeres sometidas a técnica de reproducción asistida (TRA)?

    A phase IV prospective, multicentre, randomized, open-label trial to assess the efficacy and safety of GONAL f® at a dose based on subject baseline characteristics determined according to the CONSORT calculator compared with a standard dose of GONAL f® 150 IU per day for ovarian stimulation in women undergoing assisted reproductive technology (ART)
    A.3.2Name or abbreviated title of the trial where available
    CONSORT en TRA
    A.4.1Sponsor's protocol code number28613
    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 SponsorMerck Serono International S.A.
    B.1.3.4CountrySwitzerland
    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 Yes
    D.2.1.1.1Trade name GONAL-f 450 UI/0,75 ml (33 microgramos/0,75 ml) solución inyectable en pluma precargada
    D.2.1.1.2Name of the Marketing Authorisation holderSERONO EUROPE LTD
    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.3.1Product nameGonal-f
    D.3.2Product code 95001034
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNFOLITROPINA ALFA
    D.3.9.3Other descriptive nameFOLLITROPIN ALFA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33
    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) 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 typeRecombinant Biological
    D.IMP: 2
    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 GONAL-f 900 UI/1,5 ml (66 microgramos/1,5 ml) solución inyectable en pluma precargada
    D.2.1.1.2Name of the Marketing Authorisation holderSERONO EUROPE LTD
    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.3.1Product nameGonal-f
    D.3.2Product code 95001035
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNFOLITROPINA ALFA
    D.3.9.3Other descriptive nameFOLLITROPIN ALFA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number66
    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) 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 typeRecombinant Biological
    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
    Estimulación ovárica en mujeres sometidas a técnica de reproducción asistida.

    Ovarian stimulation in women undergoing assisted reproductive technology
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10021930
    E.1.2Term Infertility NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la respuesta ovárica en pacientes sometidas a la TRA a las que se administra GONAL-f® de conformidad con la calculadora CONSORT, en comparación con una dosis estándar de 150 unidades internacionales (UI) de GONAL-f® al día.

    The overall objective of this trial is to:
    Compare the ovarian response in ART subjects administered GONAL-f according to the CONSORT calculator versus given a standard GONAL-f dose of 150 IU per day.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Para que las pacientes se consideren aptas para su inclusión en este estudio, deben reunir todos los siguientes criterios:
    1. Ser una mujer que justifique un tratamiento de FIV / transferencia de embriones.
    2. Tener una pareja varón con análisis de semen en los seis meses anteriores a la visita de asignación aleatoria considerado adecuado para proceder a la inseminación normal o inyección intracitoplasmática de espermatozoides (ICSI) según la práctica habitual del centro. Si estos criterios no se cumplen, la paciente sólo puede ser incluida si se utiliza esperma de donante.
    3. Tener una edad entre 18 y 35 años (35 no incluida) en el momento de la visita de asignación aleatoria.
    4. Un índice de masa corporal (IMC) < 30 kg/m2, donde el IMC se calcula según la siguiente fórmula:
    IMC= Peso corporal (Kg)/Talla.Talla (m2)
    5. Tener un ciclo menstrual ovulatorio espontáneo y regular, con una duración entre 21 y 35 días.
    6. Tener una concentración sérica en la fase folicular temprana (día 2 a 4) de FSH inicial ? 12 UI/l determinada en el propio laboratorio del centro durante el periodo de evaluación previa (es decir, en los dos meses anteriores al inicio de la supresión hipofisaria).
    7. Presencia de ambos ovarios.
    8. Cavidad uterina normal, que en opinión del investigador sea compatible con el embarazo.
    9. Tener una citología cervical negativa en los seis meses anteriores a la asignación aleatoria.
    10. Tener por lo menos un ciclo de reposo farmacológico (?wash-out?) (definido como ? 30 días desde la última dosis de tratamiento con citrato de clomifeno o gonadotropina) desde el último ciclo de TRA, o tratamiento con citrato de clomifeno o gonadotropina antes del inicio del tratamiento con un agonista de la GnRH.
    11. Estar dispuesta y ser capaz de cumplir el protocolo mientras dure el estudio.
    12. Haber dado el consentimiento informado por escrito, antes de cualquier procedimiento relacionado con el estudio que no constituya parte de la atención médica normal, dando por entendido que la paciente puede retirar su consentimiento en cualquier momento sin perjuicio de su atención médica futura.
    E.4Principal exclusion criteria
    Para que las pacientes sean consideradas aptas para su inclusión en este estudio, no deben reunir ninguno de los siguientes criterios:
    1. Haber tenido ? 2 ciclos de TRA anteriores con una mala respuesta a la estimulación con gonadotropina (definida como ? 5 folículos maduros, ? 3 ovocitos recogidos o ambos) o haber tenido ? 2 ciclos de TRA anteriores con una hiperrespuesta (definida como ? 25 ovocitos recuperados).
    2. Cualquier afección médica que, a juicio del investigador, pueda interferir con la absorción, distribución, metabolismo o excreción de fármaco. En caso de duda, la paciente en cuestión se debe tratar con el médico responsable de Merck Serono.
    3. Haber padecido anteriormente síndrome de hiperestimulación ovárica grave (véase el Apéndice B),
    4. Síndrome de ovario poliquístico (PCOS; criterios de Rotterdam; véase el apartado Apéndice C) para reducir el riesgo de aparición del OHSS.
    5. Presencia de endometriosis que requiera tratamiento.
    6. Mioma uterino que requiera tratamiento.
    7. Cualquier contraindicación al embarazo, a llevar el embarazo a término o ambos.
    8. Embarazo extrauterino en los tres meses anteriores a la evaluación previa.
    9. Antecedentes de tres o más abortos no provocados (abortos no provocados tempranos o tardíos) debido a cualquier causa.
    10. Tumores del hipotálamo o de la glándula hipófisis.
    11. Aumento de tamaño o quiste del ovario de etiología desconocida.
    12. Cáncer de ovario, útero o mama.
    13. Enfermedad sistémica clínicamente significativa.
    14. Infección comprobada por el virus de la inmunodeficiencia humana (VIH), o por el virus de la hepatitis B o C en la paciente del estudio o en su pareja.
    15. Hemorragia ginecológica anormal de origen indeterminado.
    16. Alergia o hipersensibilidad comprobada a las preparaciones de gonadotropina humana.
    17. Cualquier abuso activo de drogas o antecedentes de abuso de drogas, medicamentos o alcohol en los cinco años anteriores a la visita de evaluación previa.
    18. Inclusión anterior en este estudio o participación simultánea en otro ensayo clínico.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio principal de valoración de la eficacia se determinará por el número total de ovocitos recuperados por paciente después de la estimulación con GONAL f® y de la inyección de gonadotropina coriónica humana (r hCG [Ovitrelle®]) en ambos grupos de tratamiento.

    Endpoints:
    The primary efficacy endpoint will be measured by the total number of oocytes retrieved per subject following GONAL-f stimulation and human chorionic gonadotrophin (r hCG (Ovidrel/Ovitrelle) injection in both treatment arms.
    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 Yes
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    For administrative and safety reporting purposes the end of the trial will be defined as the date of the final clinical database lock.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 200
    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 Decision2008-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-23
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