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    Summary
    EudraCT Number:2011-003575-11
    Sponsor's Protocol Code Number:VitaminD&TT
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-04
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-003575-11
    A.3Full title of the trial
    A randomized, double-blind, placebo controlled trial to evaluate the effects of vitamin D supplementation on androgen levels in hypogonadal men
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vitamin D and testosterone in men
    A.3.2Name or abbreviated title of the trial where available
    Vitamin D&TT
    A.4.1Sponsor's protocol code numberVitaminD&TT
    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 SponsorMedizinische Universität Graz, Innere Medizin
    B.1.3.4CountryAustria
    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 supportÖNB Jubiläumsfonds
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Graz
    B.5.2Functional name of contact pointKlinische Studien Information
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 15
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number0043316385 12383
    B.5.5Fax number0043316385 13428
    B.5.6E-mailelisabeth.lerchbaum@medunigraz.at
    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 Oleovit D3 Tropfen
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Austria, Graz
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Oral drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNColecalciferol
    D.3.9.3Other descriptive nameCHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
    D.3.9.4EV Substance CodeSUB11818MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14400
    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 placeboOral drops
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Male hypogonadism (total testosterone <3ng/ml)
    E.1.1.1Medical condition in easily understood language
    low total testosterone levels in men
    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 14.1
    E.1.2Level HLT
    E.1.2Classification code 10000193
    E.1.2Term Male sex hormone abnormalities
    E.1.2System Organ Class 100000004872
    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 objective is to evaluate whether vitamin D supplementation with 20,000 weekly over 12 weeks significantly increases TT levels when compared to placebo.
    E.2.2Secondary objectives of the trial
    In addition, we also aim to test the hypothesis that vitamin D supplementation improves endocrine parameters (e.g. FT, SHBG, LH, FSH, and estradiol), metabolic parameters as well as sexual, physical and psychological symptoms.
    Moreover, we will evaluate whether vitamin D supplementation with 20,000 weekly over 12 weeks improves endocrine parameters (e.g. TT, FT, SHBG, LH, FSH, and estradiol) and metabolic parameters when compared to placebo in eugonadal men.
    Further, we will perform genotyping of vitamin D-related polymorphisms to evaluate a possible genetic background of the association of vitamin D with androgen levels. In addition, gene expression analyses of relevant candidate genes in association with pathways of vitamin D and testosterone will be performed at each visit in order to analyze functional changes during vitamin D treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Hypogonadal men:

    - TT levels below 3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1)
    - 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
    - Male, age of ≥ 18 and <70 years
    - Written informed consent before entered into study

    COntrol group
    - TT levels ≥3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1)
    - 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
    - Male, age of ≥ 18 and <70 years
    - Written informed consent before entered into study
    E.4Principal exclusion criteria
    - Hypercalcemia defined as a serum calcium > 2,7 mmol/L
    - Oral or transdermal testosterone supplementation in the last 2 months before entering the study
    - IM testosterone supplementation 6 months before entering the study
    - Regular intake of vitamin D supplements before study entry
    - Men with chronic diseases (such as diabetes mellitus, thyroid disease, endocrine disturbances in need of treatment (except hypogonadism), or diseases known to interfere with vitamin D intake or very sensitive to vitamin D intake (such as inflammatory disease with granuloma: sarcoidoses, tuberculosis, Mb Wegener, vasculitis, inflammatory bowel disease
    - Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, insulin, glucocorticoids,…) in the last 3 months before study entry
    - PSA >4 ng/ml (or >3 ng/ml in men at high risk for prostate cancer) (see state of the art)
    - Palpable prostate nodule or induration
    - Hematocrit >50%
    - Untreated severe obstructive sleep apnea
    - Severe lower urinary tract symptoms
    - Uncontrolled or poorly controlled heart failure
    - A history of prostate cancer, breast cancer, orchidectomy, chromosomal disorders (e.g. Klinefelter Syndrome)
    E.5 End points
    E.5.1Primary end point(s)
    Changes in total testosterone levels after vitamin D supplementation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks, 12 weeks
    E.5.2Secondary end point(s)
    Changes in
    - Endocrine parameters including FT, SHBG, LH, FSH, and estradiol
    - Insulin resistance and insulin sensitivity assessed by homeostatic model assessment-insulin resistance (HOMA-IR), HOMA-beta, MATSUDA, and Quantitative Insulin-sensitivity Check Index (QUICKI)
    - AUCins and AUCgluc derived from the oral glucose tolerance test
    - Lipid levels (total cholesterol, HDL, LDL, triglycerides)
    - Fat and lean mass assessed via dual-energy X-ray absorptiometry (DXA)
    - Sexual, physical and psychological symptoms
    after vitamin D supplementation.
    Moreover, we will perform genotyping of vitamin D-related polymorphisms (VDR Cdx-2, Bsm-I, Fok-I, Apa-I, Taq-I, GC, DHCR7 and CYP2R1). In addition, gene expression analyses will be done for biosynthesis and metabolism of male (and female) sex hormones, e.g. androgen receptor (AR), estrogen receptor (ER), aromatase (Cyp19A1), FOXL2 (Forkhead Box Protein L2), hydroxysteroid dehydrogenase 3β (HSD3β), STAR (Steroidogenic acute regulatory protein), Cytochrom-P11 (CYP11), cytochrome P17 (CYP17A1), receptors for follicle stimulating hormone (FSHR) and luteotropic hormone (LHR), SHBG (Sex-hormon binding globulin),…), important anti- and proinflammatoric genes (interleukins, interferon, FOXP3 (forkhead box P3),…), genes of glucose metabolism (IGF-1 (Insulin-like growth factor 1), IGF-1R (Insulin-like growth factor 1 Rezeptor), IGF-BP (Insulin-like growth factor binding proteins), INSL (Insulin-like peptides), insulin rezeptor (IR),…), genes of the vitamin D metabolism (vitamin D rezeptor (VDR), 25-Hydroxylasen (Cyp2R1, Cyp27A1), 24-Hydroxylase (Cyp24A1), 1-alpha-hydroxylase (Cyp27B1),…), genes of the TGF-beta superfamily (inhibins, activins and their receptos, follistatin, transforming growth factors (TGF) and their receptors, bone morphogenetic proteins (BMPs), anti müllerian hormone (AMH), growth and differentiation factor 9 (GDF9),…), as well as genes out ofbone metabolism, such as parathyrin (PTH), klotho, osteocalcin, and GPRC6A.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 weeks, 12 weeks
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    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 years0
    E.8.9.1In the Member State concerned months36
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    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 Yes
    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 state200
    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)
    Subjects will be treated with the normal treatment of that condition (according to the Endocrine Society guidelines) after the subject has ended his participation in this trial.
    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 Decision2013-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-22
    P. End of Trial
    P.End of Trial StatusOngoing
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