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    Summary
    EudraCT Number:2012-001258-25
    Sponsor's Protocol Code Number:MK8962-031-01.
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-12-18
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    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]).
    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).
    A.3.2Name or abbreviated title of the trial where available
    Corifollitropin alfa trial in adult men with hypogonadotropic hypogonadism (HH).
    A.4.1Sponsor's protocol code numberMK8962-031-01.
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/102/2014
    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.
    B.5.2Functional name of contact pointClinical Monitor.
    B.5.3 Address:
    B.5.3.1Street Address126 E. Lincoln Avenue
    B.5.3.2Town/ cityRahway NJ
    B.5.3.3Post code07065-0900
    B.5.3.4CountryUnited States
    B.5.4Telephone number17325941409
    B.5.5Fax number17325943560
    B.5.6E-mailRAMACHANDRA.NAIK@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.2.1.2Country 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 nameElonva®
    D.3.2Product code MK-8962, SCH900962.
    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 codeMK-8962
    D.3.9.3Other descriptive nameOrg 36286
    D.3.9.4EV Substance CodeSUB01455MIG
    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
    Hypogonadotrophic hypogonadism:

    Hypogonadotropic hypogonadism (HH) in males may result from either absent or inadequate gonadotropin-releasing hormone (GnRH) secretion by the hypothalamus or failure of pituitary gonadotropin secretion (luteinizing hormone (LH) & follicle stimulating hormone (FSH)). HH is characterized by androgen deficiency and by inappropriately low serum concentrations of LH and FSH.
    E.1.1.1Medical condition in easily understood language
    Men with diagnosed hypogonadotropic hypogonadism lack essential hormones, gonadotropins, and as a result of this, the testes are not stimulated to produce testosterone & sperm.
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10021012
    E.1.2Term Hypogonadotrophic hypogonadism
    E.1.2System Organ Class 100000004860
    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).
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each subject must be a male, diagnosed with hypogonadotropic hypogonadism (either congenital or acquired), and be ≥18 to ≤50 years of age at the time of signing ICF. (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 have low circulating levels of Testosterone (T): T ≤ 6 nmol/L, and low circulating levels of gonadotropins (FSH ≤ 2 IU/L and LH ≤ 2 IU/L), as assessed after an adequate wash-out period from previous testosterone use (if applicable). Each subject must have presence of scrotal testes (left and right) and must have azoospermia (according to the criteria specified in the 2010 World Health Organization [WHO] Laboratory Manual for the Examination and Processing of Human Semen, 5th Edition). Each subject must have adequate replacement of other pituitary hormones (if applicable).
    E.4Principal exclusion criteria
    The subject has primary hypogonadism such as Klinefelter's syndrome, or 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 testicular pathology of clinical importance (e.g., epididymitis, orchitis, testicular torsion, varicocele stage III, testicular atrophy, occlusive azoospermia, etc). 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, or 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 study. The subject has had hypophysectomy within a period of 6 months prior to the start of screening. The subject has a history or presence (known or suspected) of testicular, prostatic or breast cancer, has prostate pathology of clinical importance, or has past or present oncological treatment (chemo/radiotherapy). (Note: Previous local radiation of the brain in case of a pituitary tumor is allowed, but not in case of brain metastases). The subject has diabetes mellitus, untreated hyperprolactinaemia or uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders). The subject has tested positive for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C (results obtained within 1 year prior to signing ICF are considered valid).
    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).
    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.
    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).
    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.
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Australia
    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.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days3
    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.4.2 For a multinational trial
    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.
    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 Analytical Biochemical Laboratory B.V. (ABL)
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Intertek Pharmaceutical Services
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Quest Diagnostics Clinical Trials
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Quest Diagnostics Nichols Institute
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Quest Diagnostics Clinical Trials
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Focus Diagnostics, Inc.
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation Specialty Laboratories
    G.4.3.4Network Country United States
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Australia
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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