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    Summary
    EudraCT Number:2011-000633-36
    Sponsor's Protocol Code Number:000009
    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:2011-08-09
    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 number2011-000633-36
    A.3Full title of the trial
    A randomised, controlled, assessor-blind, parallel groups, multinational,
    multicentre trial assessing the dose-response relationship of FE 999049
    in controlled ovarian stimulation in women undergoing an assisted
    reproductive technology programme
    Ensayo clínico internacional, multicéntrico, aleatorizado, controlado, enmascarado para el
    evaluador y de grupos paralelos para evaluar la relación dosis-respuesta de FE 999049 en la
    estimulación ovárica controlada de mujeres que se someten a un programa de reproducción
    asistida
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, controlled, assessor-blind, parallel groups, multinational,
    multicentre trial assessing the dose-response relationship of FE 999049
    in controlled ovarian stimulation in women undergoing an assisted
    reproductive technology programme
    Ensayo clínico internacional, multicéntrico, aleatorizado, controlado, enmascarado para el
    evaluador y de grupos paralelos para evaluar la relación dosis-respuesta de FE 999049 en la
    estimulación ovárica controlada de mujeres que se someten a un programa de reproducción
    asistida
    A.4.1Sponsor's protocol code number000009
    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 SponsorFerring Pharmaceuticals A/S
    B.1.3.4CountryDenmark
    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 supportFerring Pharmaceuticals A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerring Pharmaceuticals A/S
    B.5.2Functional name of contact pointClinical Development Support
    B.5.3 Address:
    B.5.3.1Street AddressKay Fiskers Plads 11
    B.5.3.2Town/ cityCopenhagen S
    B.5.3.3Post code2300
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4528 78 77 70
    B.5.6E-mailDK0-Disclosure@ferring.com
    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 No
    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 nameFE 999049
    D.3.2Product code FE 999049
    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.3.9.2Current sponsor codeFE 999049
    D.3.9.3Other descriptive namehuman recombinant follicle-stimulating hormone
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Yes
    D.3.11.13.1Other medicinal product typevial with syringe for administration
    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 GONAL-f
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Ltd.
    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.3.1Product nameGONAL-f 900 IU/1.5 ml (66 micrograms/1.5 ml) solution for injection in pre-filled pen
    D.3.4Pharmaceutical form 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 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/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Yes
    D.3.11.13.1Other medicinal product typePre-filled pen with mulitdose cartridge
    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
    Infertilidad
    E.1.1.1Medical condition in easily understood language
    A new recombinant FSH (follicle-stimulating hormone) compound intended to induce development of multiple egg sacs in women undergoing ovarian stimulation as part of infertility treatment
    Un nuevo compuesto de FSH recombinante,que pretende inducir el desarrollo de múltiples folículos ováricos en mujeres sometidas a estimulación ovárica dentro del tratamiento contra la 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 14.0
    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
    To investigate the dose-response relationship of FE 999049 with respect to ovarian response in patients undergoing controlled ovarian stimulation
    Investigar la relación dosis-respuesta de FE 999049 en relación con la respuesta ovárica en pacientes
    sometidas a estimulación ovárica controlada
    E.2.2Secondary objectives of the trial
    To evaluate the dose-response relationship of FE 999049 with respect to endocrine profile, oocyte fertilisation, number and quality of embryos and treatment efficiency
    To evaluate the efficacy of FE 999049 with respect to achieving pregnancy
    To assess the population pharmacokinetics of FE 999049
    To evaluate the safety profile of FE 999049
    To evaluate the local tolerability of FE 999049 following subcutaneous administration
    To evaluate the immunogenicity of FE 999049
    Evaluar la relación dosis-respuesta de FE 999049 en relación con el perfil endocrino, la fecundación
    de ovocitos, el número y la calidad de embriones y la eficacia del tratamiento/ Evaluar la eficacia de
    FE 999049 en la consecución de embarazo/ Examinar la farmacocinética poblacional de FE 999049/
    Evaluar el perfil de seguridad del FE 999049/ Evaluar la tolerabilidad local de FE 999049 después de
    la administración subcutánea/ Evaluar la inmunogenia de FE 999049
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for IVF and/or ICSI treatment will be included in this trial. Subjects will be 18-37 years of age, with a body mass index (BMI) of 18.5-32.0 kg/m2 and have serum AMH levels within 5.0-44.9 pmol/L at the screening visit based on the central laboratory analysis.
    En este estudio se incluirán mujeres con un diagnóstico de infertilidad tubárica, infertilidad no
    fundamentada, infertilidad relacionada con endometriosis de fase I/II o con parejas con diagnóstico de
    infertilidad masculina, elegibles para tratamiento de IVF o ICSI. Las pacientes tendrán 18-37 años de
    edad, con un índice de masa corporal (IMC) de 18,5-32,0 kg/m2 y con concentraciones séricas de AMH
    de 5,0-44,9 pmol/l en la visita de selección conforme al análisis del laboratorio central.
    E.4Principal exclusion criteria
    Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV, history of recurrent miscarriage or with contraindications to controlled ovarian stimulation with gonadotropins will be excluded from participation in this trial. Women with three or more controlled ovarian stimulation cycles will also be excluded.
    Se excluirán de la participación en este estudio a las mujeres con síndrome del ovario poliquístico
    (SOPQ) relacionado con anovulación, endometriosis de fase III/IV, antecedentes de aborto espontáneo
    recurrente o con contraindicaciones para una estimulación ovárica controlada con gonadotropinas.
    También se excluirá a las mujeres con tres o más ciclos de estimulación ovárica controlada
    E.5 End points
    E.5.1Primary end point(s)
    Number of oocytes retrieved
    Número de ovocitos recuperados
    E.5.1.1Timepoint(s) of evaluation of this end point
    Oocyte retrieval is performed when the following criteria is met:

    ? ?3 follicles with a diameter ?17 mm
    La recuperación de ovocitos se realizará cuando se cumpla el siguiente criterio:
    ? ?3 folículos con un diámetro ?17 mm
    E.5.2Secondary end point(s)
    1. Number and size of follicles during stimulation
    2. Circulating levels of FSH during stimulation and FSH population pharmacokinetic parameters
    3. Circulating levels of LH, inhibin A, inhibin B, estradiol, progesterone, total testosterone and sex hormone binding globulin (SHBG) (free androgen index (FAI) to be calculated) during stimulation
    4. Total FE 999049 or GONAL-F dose administered and number of stimulation days
    5. Number of fertilised oocytes and fertilisation rate as well as number and quality of embryos on day 3 and blastocysts on day 5
    6. Positive ?hCG rate (positive serum ?hCG test 13-15 days after embryo transfer)
    7. Clinical pregnancy (with fetal heart beat) rate (transvaginal ultrasound showing at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after embryo transfer)
    8. Frequency and intensity of adverse events
    9. Changes in circulating levels of clinical chemistry and haematology parameters and proportion of subjects with markedly abnormal changes
    10. Frequency and intensity of injection site reactions (redness, pain, itching, swelling and bruising) assessed by the subject three times daily during the stimulation period
    11. Proportion of subjects with treatment-induced anti-FSH antibodies
    12. Proportion of subjects with treatment-induced anti-FSH antibodies with neutralising capacity
    1. Número y tamaño de folículos durante la estimulación
    2. Concentraciones de FSH en la circulación durante la estimulación y parámetros farmacocinéticos poblacionales de FSH
    3. Concentraciones en la circulación de LH, inhibina A, inhibina B, estradiol, progesterona, progesterona total y globulina transportadora de hormonas sexuales (SHBG) (calcular el índice de andrógenos libres (FAI)) durante la estimulación
    4. Dosis total de FE 999049 o GONAL-F administrada y número de días de estimulación
    5. Número de ovocitos fecundados y tasa de fecundación, así como número y calidad de los embriones en el día 3 y blastocistos en el día 5
    6. Tasa de ?hCG positiva (prueba positiva de ?hCG en suero 13-15 días después de la transferencia de embriones)
    7. Tasa de embarazos clínicos (con latido cardíaco fetal) (ecografía transvaginal que muestra al menos un saco gestacional intrauterino con latido cardíaco fetal 5-6 semanas después de la transferencia embrionaria)
    8. Frecuencia e intensidad de los acontecimientos adversos
    9. Cambios en las concentraciones circulantes de parámetros bioquímicos y hematológicos y proporción de pacientes con cambios marcadamente anormales
    10. Frecuencia e intensidad de las reacciones en el lugar de inyección (enrojecimiento, dolor, prurito, tumefacción y hematoma) evaluadas por las pacientes tres veces al día durante el periodo de estimulación
    11. Proporción de pacientes con anticuerpos anti-FSH inducidos por el tratamiento
    12. Proporción de pacientes con anticuerpos anti-FSH inducidos por el tratamiento con capacidad neutralizante
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Evaluated at each visit during stimulation
    2. Day 4, day 6 and each subsequent stimulation visits
    3. Day 4, day 6 and each subsequent stimulation visits
    4. End of stimulation day
    5. Day 0 to day 5 after oocyte retrieval
    6. ?hCG test 13-15 days after embryo transfer
    7. 5-6 weeks after embryo transfer
    8. From signing informed consent until end of trial visit
    9. End of stimulation and End of trial
    10. Evaluated 3 times daily during the stimulation period
    11. 8-10 days after last IMP dose and 21-28 days after last IMP dose
    12. Evaluation performed after last sample, first sample taken predosing, second 8-10 days after last IMP dose, third 21-28 days after last IMP dose
    1. Evaludados en cada visita durante estimulación
    2. Día 4 , día 6 y cada subsiguiente visita de estimulación
    3. Día 4 , día 6 y cada subsiguiente visita de estimulación
    4. Final del día de estimulación
    5. Día 0 a día 5 después de la recuperación de ovocitos
    6. Test ?hCG 13-15 días después de la transferencia de embriones
    7. 5-6 semanas después de la transferencia de embriones
    8. Desde la firma del consentimiento informado hasta la visita final del estudio
    9. Final de la estimulación y final del estudio
    10. Evaludos 3 veces diariamente durante el periodo de estimulación
    11. 8-10 días después de la última dosis del MI y 21-28 días después de la última dosis del MI
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Enmascarado para el evaluador
    Assessor blinded
    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 trial6
    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 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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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 último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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.1.1Number of subjects for this age range: 0
    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: 330
    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 state220
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 330
    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)
    Not applicable
    No aplicable
    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 Decision2011-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-25
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