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    Summary
    EudraCT Number:2012-001258-25
    Sponsor's Protocol Code Number:MK8962-031
    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:2012-08-09
    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 number2012-001258-25
    A.3Full title of the trial
    A phase III, multi-center, open label, uncontrolled trial to investigate the efficacy and safety of MK-8962 (corifollitropin alfa) in combination with human Chorionic Gonadotropin (hCG) in inducing increased testicular volume and spermatogenesis in adult men with hypogonadotropic hypogonadism who remain azoospermic when treated with hCG alone (Phase III; Protocol No. MK-8962-031-00 [also known as SCH 900962, P07937])
    Ensayo en fase III, multicéntrico, abierto y no controlado para investigar la eficacia y la seguridad de MK 8962 (corifolitropina alfa) en combinación con gonadotropina coriónica humana (hCG) para inducir un aumento del volumen testicular y la espermatogenia en varones adultos con hipogonadismo hipogonadótropo y azoospermia persistente tras el tratamiento con hCG en monoterapia (fase III; protocolo n.º MK 8962 031 00 [también denominado SCH 900962, P07937])
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Corifollitropin alfa trial in adult men with hypogonadotropic hypogonadism (HH)
    Ensayo de corifolitropina alfa en varones adultos con hipogonadismo hipogonadótropo (HH)
    A.3.2Name or abbreviated title of the trial where available
    Corifollitropin alfa trial in adult men with hypogonadotropic hypogonadism (HH)
    Ensayo de corifolitropina alfa en varones adultos con hipogonadismo hipogonadótropo (HH)
    A.4.1Sponsor's protocol code numberMK8962-031
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/182/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, New Jersey
    B.5.3.3Post code08889
    B.5.3.4CountryUnited States
    B.5.4Telephone number+31412663353
    B.5.5Fax number+31412663353
    B.5.6E-mailb.mannaerts@merck.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 Yes
    D.2.1.1.1Trade name ELONVA
    D.2.1.1.2Name of the Marketing Authorisation holderNV Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
    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 namecorifollitropin alfa
    D.3.2Product code MK-8962, SCH 900962
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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
    Adult men with hypogonadotropic hypogonadism
    Varones adultos con hipogonadismo hipogonadótropo
    E.1.1.1Medical condition in easily understood language
    Adult men with hypogonadotropic hypogonadism
    Varones adultos con hipogonadismo hipogonadótropo
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10021012
    E.1.2Term Hypogonadotrophic hypogonadism
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the trial are: 1) to assess the efficacy of 150 µg MK-8962, given once every two weeks for 52 weeks - in combination with a twice weekly dose of hCG - to increase testicular volume measured as the sum of volumes of left and right testes by ultrasound in men with hypogonadotropic hypogonadism who remain azoospermic after 16 weeks of hCG alone and 2) to evaluate whether treatment with 150 µg MK-8962 for 52 weeks in combination with hCG is safe in HH men, as evaluated by the occurrence of (serious) adverse events and presence of anti-MK-8962 antibodies (pre-specified safety endpoint).
    1.Evaluar la eficacia de MK 8962 150 µg, administrado una vez cada dos semanas durante 52 semanas, en combinación con una dosis dos veces a la semana de hCG, para aumentar el volumen testicular medido como la suma del volumen de ambos testículos por ecografía en varones con hipogonadismo hipogonadótropo que presentan azoospermia persistente después de 16 semanas de tratamiento con hCG en monoterapia.
    2.Evaluar si el tratamiento con MK 8962 150 µg durante 52 semanas en combinación con hCG es seguro en varones con HH, a juzgar por la aparición de acontecimientos adversos (graves) y la presencia de anticuerpos anti MK 8962 (criterio de valoración de la seguridad especificado de antemano).
    E.2.2Secondary objectives of the trial
    The key secondary objectives are 1) to assess the efficacy of 150 µg MK-8962, given once every two weeks for 52 weeks - in combination with a twice weekly dose of hCG - to induce spermatogenesis resulting in a sperm count ? 1x106 / mL in HH men who remain azoospermic after 16 weeks of hCG alone, and 2) to characterize the pharmacokinetics of MK-8962 in HH men after subcutaneous (SC) administration of 150 µg MK-8962 based on serum MK-8962 concentrations. Other secondary objectives are to evaluate the effect of 150 µg MK-8962 in combination with hCG on endocrinological parameters (FSH, LH, hCG, total testosterone [total T], estradiol [E2], sex hormone-binding globulin [SHBG], inhibin-B, and anti-Müllerian hormone [AMH]) as determined by a central laboratory and on sperm parameters (concentration, morphology, motility) as determined by the local laboratory of each clinic.
    1.Evaluar la eficacia de MK 8962 150 µg, administrado una vez cada dos semanas durante 52 semanas, en combinación con una dosis dos veces a la semana de hCG, para inducir la espermatogenia con aparición de un recuento de espermatozoides ? 1 x 106/ml en varones con HH que presentan azoospermia persistente después de 16 semanas de tratamiento con hCG en monoterapia.
    2.Definir la farmacocinética (FC) de MK 8962, basándose en su concentración sérica, durante 52 semanas de tratamiento en varones con HH tras la administración subcutánea (SC) de 150 µg de MK 8962.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ICF (Version 00 Genetic and future samples 27/06/2012)
    HIP (Versión 00 Genético y Muestras Futuras del 27/06/2012)
    E.3Principal inclusion criteria
    -Each subject must have been diagnosed with HH, either congenital or acquired. Note: Subjects with drug-induced HH (e.g. misuse of anabolic steroids, chronic use of glucocorticoids or narcotic analgesics, etc.) are not allowed to participate.
    -Each subject must be ?18 to ?50 years of age at the time of signing ICF.
    -Each subject must have low circulating levels of Testosterone (T): T ? 6 nmol/L, as assessed after an adequate wash-out period from previous testosterone use (if applicable).
    -Each subject must have low circulating levels of gonadotropins: follicle stimulating hormone (FSH) ? 2 IU/L and luteinizing hormone (LH) ? 2 IU/L (after adequate wash-out from previous testosterone use [if applicable]).
    - Each subject must have presence of scrotal testes (left and right).
    - Each subject must have azoospermia (according to the World Health Organization [WHO] criteria).
    -El sujeto debe tener un diagnóstico de HH, ya sea congénito o adquirido. Nota: No podrán participar sujetos con HH de origen farmacológico (por ejemplo, uso incorrecto de esteroides anabolizantes, uso prolongado de glucocorticoides o analgésicos opiáceos, etc.).
    -El sujeto debe tener entre ? 18 y ? 50 años de edad en el momento de firmar el DCI.
    -El sujeto debe tener una concentración circulante baja de testosterona (T): T ? 6 nmol/l, evaluada tras un período adecuado de lavado del uso previo de testosterona (si procede).
    -El sujeto debe tener concentraciones circulantes bajas de gonadotropinas: folitropina (FSH) ? 2 UI/l y lutropina (LH) ? 2 UI/l (tras el período adecuado de lavado del uso previo de testosterona [si procede]).
    -El sujeto debe tener testículos escrotales (derecho e izquierdo).
    -El sujeto debe tener azoospermia (según los criterios de la Organización Mundial de la Salud [OMS]).
    E.4Principal exclusion criteria
    -The subject has primary hypogonadism, such as Klinefelter's syndrome.
    -The subject has a history of unilateral or bilateral cryptorchidism (maldescended testes). Note:
    Subjects with a history of unilateral cryptorchidism which was treated before the age of 2 years are allowed in this trial.
    - The subject has a history or presence of testicular pathology of clinical importance (e.g., epididymitis,
    orchitis, testicular torsion, varicocele stage III, testicular atrophy, occlusive azoospermia, etc), and/or vasectomy.
    - The subject has been treated with FSH, hCG or gonadotropin releasing hormone (GnRH) within a period of three months prior to signing informed consent or for more than one month within a period of six months prior to signing informed consent.
    -The subject has proven spermatogenesis upon hCG treatment alone.
    - The subject has had a previous unsuccessful attempt with hCG in combination with human menopausal gonadotropin (hMG)/FSH to achieve spermatogenesis.
    - The subject had required a dose of hCG of more than 6000 IU per week in a previous attempt to normalize T levels.
    - The subject has untreated pituitary or hypothalamic tumor, or inadequately treated pituitary or hypothalamic tumor that is likely to progress during the trial.
    - The subject has had hypophysectomy within a period of 6 months prior to the start of screening.
    At Visit 6 / Day 1
    Key Inclusion Criteria:
    - Each subject must have circulating T levels within the normal range
    - Each subject must still have azoospermia (according to WHO criteria).
    -El sujeto presenta hipogonadismo primario, como síndrome de Klinefelter.
    -El sujeto tiene antecedentes de criptorquidia uni o bilateral. Nota: En este ensayo podrán participar sujetos con antecedentes de criptorquidia unilateral tratada antes de los 2 años de edad.
    -El sujeto tiene antecedentes o presencia de trastornos testiculares de importancia clínica (por ejemplo, epididimitis, orquitis, torsión testicular, varicocele en estadio III, atrofia testicular, azoospermia obstructiva, etc.), o vasectomía.
    -El sujeto ha sido tratado con FSH, hCG o gonadoliberina (GnRH) en los tres meses anteriores a la firma del consentimiento informado o durante más de un mes en los seis meses anteriores a la firma del consentimiento informado.
    -El sujeto presenta espermatogenia confirmada durante el tratamiento con hCG en monoterapia.
    -El sujeto ha tenido un intento infructuoso previo con hCG en combinación con gonadotropina menopáusica humana (hMG)/FSH para lograr la espermatogenia.
    -El sujeto ha precisado una dosis de hCG superior a 6000 UI por semana en un intento previo para normalizar la concentración de T.
    -El sujeto presenta un tumor hipofisario o hipotalámico no tratado o tratado inadecuadamente que probablemente mostrará progresión durante el ensayo.
    -El sujeto se ha sometido a una hipofisectomía en los 6 meses anteriores al inicio de la selección.

    En la visita 6/día 1
    Criterios de inclusión fundamentales:
    -El sujeto debe tener una concentración circulante de T dentro del intervalo normal.
    -El sujeto debe seguir presentando azoospermia (según los criterios de la OMS).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for the current trial is the change from baseline from Day 1 (i.e., the first day of combined treatment with MK-8962 and hCG) to Week 52 in log-transformed testicular volume (measured as the sum of volumes of left and right testes by ultrasound).
    El criterio de valoración principal de la eficacia del presente ensayo es la variación con respecto al momento basal entre el día 1 (es decir, el primer día de tratamiento combinado con MK 8962 y hCG) y la semana 52 del volumen testicular transformado logarítmicamente (medido como la suma de los volúmenes de los testículos izquierdo y derecho por ecografía).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Wk -16, Wk -8, Wk -1, Day 1 and every 4 weeks thereafter till Wk 52
    Semana -16, semana -8, semana -1, Día 1 y cada 4 semanas hasta la semana 52
    E.5.2Secondary end point(s)
    -Induced spermatogenesis (i.e., sperm count ? 1x106 / mL).
    -characterization of MK-8962 pharmacokinetics in HH men based on MK-8962 serum concentration data.
    -Sperm concentration
    -Sperm morphology
    -Sperm motility
    -Serum hormone levels (FSH, LH, hCG, total testosterone, E2, SHBG, inhibin-B, and AMH).
    -Porcentaje de sujetos con espermatogenia inducida (es decir, recuento de espermatozoides ? 1 x 106/ml).

    -Determinación de la farmacocinética de MK 8962 en varones con HH basándose en la concentración sérica de MK 8962.
    -Concentración, morfología y motilidad de los espermatozoides.
    -Concentraciones séricas de hormonas (FSH, LH, hCG, T total, E2, SHBG, inhibina B y AMH).
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Sperm parameters: Wk -16, Wk -1, Wk 16, Wk 28, Wk 40 and Wk 52/discontinuation visit
    -PK of MK-8962: detailed PK sampling during the first 2 weeks of treatment (6 visits), Wk 4, Wk 16, Wk 28, Wk 40, Wk 52/ discontinuation visit, and post-treatment follow-up visit.
    -Serum hormone levels: Wk-16, Wk-8, Wk-1, every 4 weeks thereafter till Wk52, and post-treatment follow-up visit.
    -Parámetros de espermatozoides: Semana-16, Semana -1, Semana 16, Semana 28, Semana 40 and Semana 52/visita de discontinuación.
    -Farmacocinética de MK 8962: Toma de muestras detalladas de PK durante las 2 primeras semanas de tratamiento (6 visitas), Semana 4, Semana 16, Semana 28, Semana 40, semana 52/visita de discontinuación y en la visita de seguimiento de post-tratamiento.
    -Concentraciones séricas de hormonas: Semana-16, Semana-8, Semana-1, y cada 4 semanas hasta la semana 52 y en la visita de seguimiento de post-tratamiento
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA12
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Finland
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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 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: 20
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 20
    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)
    If the patient had not yet achieved spermatogenesis after he has ended his participation in the trial, he can continue to receive the standard of care for his condition.
    Si el paciente no consigue presentar espermatogenia después de haber terminado su participación en el estudio, puede continuar recibiendo el tratamiento habitual para su estado
    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 Decision2012-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-08
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