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    Summary
    EudraCT Number:2009-017139-16
    Sponsor's Protocol Code Number:Bay 86-5037/14853
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-03-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-017139-16
    A.3Full title of the trial
    Effect of exercise alone or in combination with testosterone replacement on muscle strength and quality of life in older men with low testosterone concentrations: a randomized double-blind, placebo controlled study
    A.4.1Sponsor's protocol code numberBay 86-5037/14853
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 Nebido 1000 mg Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderBayer HealthCare AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameNebido
    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 IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTestosterone undecanoate
    D.3.9.1CAS number 5949-44-0
    D.3.9.3Other descriptive nameTESTOSTERONE UNDECYLATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The objective of this study is to determine whether in older men with symptomatic age-associated testosterone deficiency exercise training in combination with testosterone replacement therapy leads to improvement of muscle strength, physical function and quality of life more than exercise alone.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10021011
    E.1.2Term Hypogonadism male
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Additional effect of TRT in hypogonadal men on dynamic maximum strength (one repetition maximum, 1-RM) of upper and lower extremity
    E.2.2Secondary objectives of the trial
    Effect of TRT in hypogonadal men on further muscle parameters, endurance, cardiovascular parameters and Quality of Life (QoL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men aged 60 years and older (>60yrs), untrained
    2. Symptomatic hypogonadism as defined by i and iii:
    i Total testosterone below 12nmol/l (two tests taken on two different
    days, measurement 7.00-11.00 a.m.)
    ii Symptoms of testosterone deficiency recorded in the medical history at
    screening
    and
    ii Total Aging Males’ Symptom score above 36
    3. Willing to avoid significant change in the pattern of physical exercise and
    lifestyle for the duration of the study
    4. Residence in Cologne Area
    5. Written informed consent
    E.4Principal exclusion criteria
    1. Previous assignment to treatment during this study
    2. Use of androgen therapy or anabolic steroids within 12 months of
    entry into the study (i.e. screening visit/visit 1)
    3. Current participation in an exercise program or within the last 6 months
    4. Suspicion or known history of prostate or breast cancer or other hormone
    dependent neoplasia
    5. Abnormal finding on Digital Rectal Examination (DRE)
    6. Prostate specific antigen (PSA) level ≥4ng/ml
    7. History of clinically significant post void residual urine (> 150ml)
    8. Suspicion or known history of liver tumor
    9. Hypersensitivity to the active substances or any of the excipients of
    NEBIDO e.g. benzyl-benzoate and castor oil
    10. Blood coagulation irregularities presenting an increased risk of bleeding
    after intramuscular injections including vitamin-K-antagonists or other
    strong anticoagulants
    11. Hypercalcemia accompanying malignant tumors
    12. Diagnosed sleep apnea
    13. Polycythemia
    14. Hematocrit level >50% at entry to the study (i.e. screening visit/visit 1)
    15. Use of 5-α-reductase inhibitors (finasteride, dutasteride)
    16. Prolactin level >25ng/ml
    17. Organic hypothalamic-pituitary pathology
    18. Concurrent use of: androgens including dehydroepiandrosterone (DHEA),
    anabolic steroids, clomipramine, antiandrogens, estrogen, corticotrophins
    (ACTH), corticosteroids, oxyphenbutazone, growth hormone
    19. Body mass index >35kg/m2
    20. Uncontrolled thyroid disorders
    21. Uncontrolled diabetes mellitus (HbA1c > 9%)
    22. Epilepsy not adequately controlled by treatment
    23. Migraine not adequately controlled by treatment
    24. Patients requiring or undergoing fertility treatment
    25. Any clinically significant chronic disease that might, in the opinion of the
    investigator, compromise patient’s safety, interfere with the evaluations,
    or preclude completion of the trial (e.g. hemochromatosis, chronic lung
    disease, chronic malabsorption disease)
    26. Known history of alcohol or drug / substance abuse
    27. Any medical, psychiatric or other conditions that compromise the patient’s
    ability to understand the patient information, to give informed consent, to
    comply with the trial protocol, to understand the questionnaires, to follow
    the training instructions or to complete the study (e.g.: illiterate; severe
    visual impairment, severe hearing imparment in the opinion of the
    investigator).
    28. Patients under legal protection
    29. Hypertension which is not adequately controlled
    30. Heart failure (NYHA II-IV)
    31. Severe hepatic or severe renal insufficiency in the opinion of the
    investigator
    32. Cardiopulmonary disease (Myocardial infarction, angina pectoris),
    Coronary heart disease not stabilized by therapy (unstable angina
    pectoris, severe cardiac dysrhythmia/arrhythmia), chronic obstructive
    pulmonary disease (COPD), history of cerebrovascular accident (transient
    ischemic attack [TIA], stroke), neuromuscular impairments or unstable
    medical condition that would contraindicate progressive resistance and
    endurance exercise training in the opinion of the investigator
    33. Concomitant participation in another clinical trial within 1 month of entry
    into this study (i.e. randomized and has taken study medication)
    34. Inability to exercise safely in the opinion of the investigator
    35. Visual or hearing impairment, interfering with following direction
    36. History of malignancy diagnosed within the past 5 years of except for non-
    melanoma skin cancer (other than squamous or basal cell cancer)
    37. History of diagnosed osteoporosis
    38. History of herniated vertebral disk within the last 6 month
    39. Acute inflammation of the musculoskeletal system
    40. Severe rheumatic disorder or arthropathy
    41. Endoprothesis in situ (e. g. hip, knee)
    42. Close affiliation with the investigational site (e.g. close relative of the
    investigator, dependent person)
    E.5 End points
    E.5.1Primary end point(s)
    Additional effect of testosterone replacement therapy in hypogonadal men on dynamic maximum strength (one repetition maximum - 1-RM - of upper and lower extremety)
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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 Yes
    E.7.1.3.1Other trial type description
    Hypothesis generating study
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 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 Information not present in EudraCT
    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
    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 years0
    E.8.9.2In all countries concerned by the trial months0
    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) No
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Patients completing the 54 weeks treatment period will not be given further free access to study medication. The investigator will decide in consultation with the individual patient about the further clinical management and treatment alternatives.
    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 Decision2010-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-07-06
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