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    Summary
    EudraCT Number:2008-002053-20
    Sponsor's Protocol Code Number:DC00065/91579
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-08-19
    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 ConcernedLatvia - SAM
    A.2EudraCT number2008-002053-20
    A.3Full title of the trial
    A 54 week treatment, randomized, multi center, double blind, placebo controlled study to assess the safety and efficacy of NEBIDO 1000 mg (4 ml) in elderly men with symptomatic late onset hypogonadism (SLOH)
    A.3.2Name or abbreviated title of the trial where available
    NEBIDO in SLOH
    A.4.1Sponsor's protocol code numberDC00065/91579
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Schering Pharma 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.3.4Pharmaceutical 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.3.9.2Current sponsor codeDC00065
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Symptomatic late onset hypogonadism
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    Efficacy and safety of NEBIDO in men with symptomatic late onset hypogonadism (SLOH) as characterized in the protocol inclusion criteria:

    To assess the change from baseline in lean body mass after 54 weeks of treatment with NEBIDO compared to placebo, measured by dual energy X-ray absorptiometry (DEXA).

    Safety parameters
    • Adverse event
    • Clinical laboratory evaluations (i.e. FBC, creatinine, glucose, potassium, calcium and HbA1c) vital signs, physical examination findings, and other observations related to safety e.g. DRE and IPSS
    • Standard laboratory tests for androgen treatment: prostate specific antigen (PSA); hemoglobin; hematocrit,
    • Laboratory tests for lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol and Triglycerides) and liver function tests (aspartate aminotransferase [AST] and alanine transaminase [ALT])


    E.2.2Secondary objectives of the trial
    To assess the:
    • Change from baseline in total body mass, measured by DEXA
    • Change from baseline in fat mass, measured by DEXA
    • Change from baseline in visceral fat mass, measured by DEXA
    • Change from baseline in bone mineral density, measured by DEXA
    • Aging Male Symptoms (AMS) rating scale ( Total score)
    • Aging Male Symptoms (AMS) rating scale (sexual function sub domain)
    • International Index of Erectile Function- erectile function domain (IIEF-EF)
    • Change in serum levels of testosterone (central laboratory)
    • Change in waist circumference
    Where change from baseline, in the first 4 bullet points above, stands for change from baseline after 54 weeks of treatment with NEBIDO compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men aged 50 and older
    2. Symptomatic hypogonadism as defined by i and ii:
    i. Total testosterone below 12nmol/l
    ii. 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. Willing to voluntarily sign a statement of informed consent to participate in the study
    E.4Principal exclusion criteria
    1. Use of androgen therapy or anabolic steroids within 12 months of entry into the study (i.e. screening visit/visit 1)
    2. Suspicion or known history of prostate or breast cancer
    3. Suspicion or known history of liver tumors
    4. Hypersensitivity to the active substances or any of the excipients of NEBIDO e.g. Benzyl benzoate and castor oil. Hypercalcemia accompanying malignant tumors
    5. Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injections
    6. Diagnosed sleep apnea
    7. Polycythemia
    8. Hematocrit level >50% at entry to the study (i.e. screening visit/visit 1)
    9. Patients using 5-α-reductase inhibitors such as finasteride or dutasteride should be excluded from the study.
    10. Prolactin level >25ng/ml
    11. Organic hypothalamic-pituitary pathology
    12. Severe psychiatric disease
    13. Prostate specific antigen (PSA) level ≥4ng/ml
    14. Severe symptomatic benign prostatic hyperplasia (IPSS sum score ≥20)
    15. Concurrent use of androgens including dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens, estrogen, cytochrome P450 inducing medicines (e.g. quinidine, ketoconazole, macrolides), corticotrophins (ACTH) and oxyphenbutazone
    16. Body mass index >35kg/m2
    17. Uncontrolled thyroid disorders
    18. Diabetes mellitus with vascular changes or which is uncontrolled
    19. Epilepsy not adequately controlled by treatment
    20. Migraine not adequately controlled by treatment
    21. Patients requiring or undergoing fertility treatment
    22. 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)
    23. Known history of alcohol or drug abuse
    24. 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, or to complete the study.
    25. Hypertension which is not adequately controlled on therapy
    26. Severe cardiac, hepatic or renal insufficiency
    27. Coronary heart disease not stabilized by therapy as assessed by the investigator
    28. Metal implants in the body (metal implants in the head will not exclude patients from participation)
    29. Concomitant participation in another clinical trial within 1 month of entry into this study (i.e. randomized and has taken study medication).
    E.5 End points
    E.5.1Primary end point(s)
    To assess the change from baseline in lean body mass after 54 weeks of treatment with NEBIDO compared to placebo, measured by dual energy X-ray absorptiometry (DEXA).
    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 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) 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Last patient last visit
    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 months1
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days12
    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) 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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 390
    F.4.2.2In the whole clinical trial 435
    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.
    The investigator must provide follow-up medical care for all patients who complete the study or who are prematurely withdrawn from the study, or must refer them for appropriate ongoing care.
    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 Decision2008-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-10-13
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