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    Summary
    EudraCT Number:2018-002365-19
    Sponsor's Protocol Code Number:2
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-06-27
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-002365-19
    A.3Full title of the trial
    Muscle strength and -mass after bariatric surgery - a possible effect of testosterone replacement therapy?
    Randomized, placebo-controlled and double-blinded study
    Effekten af testosteron på kropsvægt og muskelstyrke hos overvægtige mænd, der gennemgår bariatrisk kirurgi– en randomiseret, placebokontrolleret og dobbeltblindet undersøgelse af mænd med lav-normale testosteronniveauer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Testosterone in bariatric patients
    Testosteron behandling af mænd der undergår bariatrisk kirurgi.
    A.3.2Name or abbreviated title of the trial where available
    Testosterone in bariatric patients
    A.4.1Sponsor's protocol code number2
    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 SponsorLine Velling Magnussen
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHospital of Southwest Jutland
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportOdense University Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion of Southern Denmark
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital of Southwest Jutland
    B.5.2Functional name of contact pointLine Velling Magnussen
    B.5.3 Address:
    B.5.3.1Street AddressHaraldsgade 7F
    B.5.3.2Town/ cityEsbjerg
    B.5.3.3Post code6700
    B.5.3.4CountryDenmark
    B.5.4Telephone number004579185085
    B.5.6E-mailline.velling.magnussen@rsyd.dk
    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 AB
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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) 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 No
    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
    General aim
    To investigate the effect and clinical relevance of testosterone therapy combined with exercise and diet counselling in hypogonadal men undergoing bariatric surgery.

    Objectives
    To evaluate the effect of testosterone therapy combined with exercise and diet counselling on muscle strength, body composition, hormones, components of the metabolic syndrome, inflammation, sexual function, and quality of life after weight loss in obese, hypogonadal men undergoing bariatric surgery.
    -
    E.1.1.1Medical condition in easily understood language
    -
    Kan man bibeholde muskelmassen og muskelstyrken under et vægttab foranlediget af gastric bypass ved at behandle mænd med nedsat testosteron i blodet med testosteron og livsstilsændringer
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    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 effect and clinical relevance of testosterone therapy combined with exercise and diet counselling in hypogonadal men undergoing bariatric surgery.
    -
    E.2.2Secondary objectives of the trial
    To evaluate the effect of testosterone therapy combined with exercise and diet counselling on muscle strength, body composition, hormones, components of the metabolic syndrome, inflammation, sexual function, and quality of life after weight loss in obese, hypogonadal men undergoing bariatric surgery.
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Eligible for bariatric surgery according to the Danish national criteria (i.e. aged 18‒60 years, BMI >35 kg/m2 with specific secondary disease or BMI >40 kg/m2 with significant health issues assessed by the multidisciplinary bariatric team) [41]
    - Caucasian men
    - Total testosterone < 12.0 nmol/l
    - No contraindications for testosterone treatment
    E.4Principal exclusion criteria
    - Previously diagnosed with prostate, mammae or liver cancer. Any other cancer within the last 5 years.
    - Symptomatic heart disease NYHA >2
    - Recently thromboembolic disease <3 months
    - PSA >4.0 ug/l or PSA>3.0 ug/l and lower urinary tract symptoms
    - Disability that severely affect the ability to perform exercise training
    - EVF > 52%
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome:
    - Maximal isometric muscle strength (N) in shoulder muscles (shoulder elevation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    December 2020 – December 2024
    Last-patient-last-visit December 2024
    Inklusion af første projektdeltager d. 15. december 2020. Vi har forventet slutdato (last-patient-last-visit) i december 2024.
    E.5.2Secondary end point(s)
    Secondary outcomes:
    - Regional body composition (DXA scan, BMI, Waist/hip-ratio)
    - Physical strength: maximal isometric muscle strength in lower extremities (hip extension, hip abduction), muscle strength in upper-extremities (shoulder abduction, shoulder adduction)
    - Physical function: performance-based measures of physical function (stair climb test) and maximal oxygen uptake (VO2max).
    - Glucose metabolism (HOMA-R, HbA1c, Fasting-P-Blood glucose)
    - Coagulation/fibrinolysis status (thrombin generation measures)
    - Adipokines and inflammation markers (leptin, adiponectin, hsCRP, IL-6, suPAR, lipid profile (HDL, LDL, triglycerides))
    - Hormones and binding proteins (testosterone, SHBG, LH, FSH, prolactin, CBG, growth hormone-axis (IGF-I and IGF-II, IGFBPs, bioactive IGF-I), cortisol, aldosterone, Cortisol and cortisol metabolites)
    - Vascular markers (soluble Klotho, fibulin-1)
    - Bone markers and calcitropic hormones (osteocalcin, PICP, 1CTP, CTX, PTH, 25OH-vitaminD, 1.25(OH)2-Vitamin-D)
    - Quality of life and sexual function (International Index of Erectile Function (IIEF-5), Profile of Mood States – short form (POMS-sf), Major Depression Inventory (MDI), World Health Organization Well Being Index (WHO-5), Physical function component of Vitality scale of Short Form 36 (SF36)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 2025
    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 No
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 50
    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 state50
    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)
    None
    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 Decision2018-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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