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    Summary
    EudraCT Number:2010-021268-13
    Sponsor's Protocol Code Number:Letrozole2010-1
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-10-11
    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 ConcernedIreland - HPRA
    A.2EudraCT number2010-021268-13
    A.3Full title of the trial
    The Effects of Normalising Sex Hormone Levels in Obese Hypogonadal Men: A Prospective Randomized Comparator Controlled Parallel Arm Clinical Trial
    A.3.2Name or abbreviated title of the trial where available
    Normalising Sex Hormone Levels in Obese Hypogonadal Men
    A.4.1Sponsor's protocol code numberLetrozole2010-1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN21665331
    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 SponsorUniversity College Dublin
    B.1.3.4CountryIreland
    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 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 Femara 2.5mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceutical UK Limited, Trading as Ciba Laboratories
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNLETROZOLE
    D.3.9.1CAS number 112809-51-5
    D.3.9.2Current sponsor codeLetrozole
    D.3.9.3Other descriptive nameAromatase Inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 Yes
    D.3.11.13.1Other medicinal product typeEnzyme inhibitor. Non-steroidal aromatase inhibitor (inhibitor of oestrogen biosynthesis)
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 1000mg/4ml, solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Limited, The Atrium, Blackthorn Road, Dublin 18
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.9.1CAS number 5949-44-0
    D.3.9.2Current sponsor codeTestosterone
    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 Yes
    D.3.11.13.1Other medicinal product typeAndrogens, 3-oxoandrosten (4) derivatives. Testosterone undecanoate is an ester of the naturally occurring androgen, testosterone.
    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
    Obesity Related Male Hypogonadism
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    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
    The primary objective of the research project is to determine the effect of twelve weeks’ treatment with an aromatase inhibitor (Femara®, 2.5mg weekly) on the change in the serum concentration of the pro-inflammatory cytokine, C Reactive Protein, as measured by the Roche® Cobas immuno-turbidimetric test and compare it to that of twelve weeks’ treatment with a depot intramuscular formulation of testosterone undecanoate (Nebido®, 1g every 6 weeks) and to that of six weeks of no treatment.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the research project are to determine the effect of twelve weeks’ treatment with Femara® compared to Nebido® and compared to no treatment on:
    1. The change in the serum concentration of other pro-inflammatory cytokines: IL-6, TNFα, IL1β, IFNγ;
    2. The change in the time taken to walk 500m at a moderately intense pace;
    3. The change in erectile function, as measured by the International Index of Erectile Function (IIEF);
    4. The change in modifiable cardiovascular disease risk factors including blood pressure, glycosylated haemoglobin, insulin resistance, lipid fractions and weight as measured by standard, hospital standard, clinical methods;
    5. The change in quality of life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men who satisfy all of the following may be included in the study:
    1. Age between 18 and 65 years inclusive
    2. Body mass index (BMI) greater than 30kg/m2
    3. Serum total testosterone concentrations less than 8.0nmol/L on two consecutive occasions. The blood that will be used for measurement of the testosterone concentrations will be taken from research participants after a 12 hour fast and between the hours of 0800 to 1100.
    4. Willingness to voluntarily sign a statement of informed consent to participate in the study.
    E.4Principal exclusion criteria
    Men with any of the following conditions will be excluded from the study:
    1. Use of systemic glucocorticoid, sex hormone or anticoagulant therapy, or a medication known to effect sex hormone bioactivity during the 6 months prior to study entry (i.e. screening visit)
    2. Known hypersensitivity to the active substances or any of the excipients of Femara® or Nebido®
    3. Hypothalamic pituitary disease
    4. Untreated obstructive sleep apnoea syndrome
    5. Haemophilia
    6. Psychotic mental illness
    7. Inability to understand the participant information or to give informed consent
    8. History of cancer
    9. History of prostatic intra-epithelial neoplasia (PIN)
    10. Severe lower urinary tract symptoms (International Prostate Symptom Score >19)
    11. Erythrocytosis (Haematocrit > 0.5, or Haemoglobin > 17g/dl)
    12. Prostate specific antigen (PSA) level >3ng/ml
    13. Moderate to severe chronic kidney disease (eGFR <30ml/min/1.73m2)
    14. Severe liver disease (serum Alanine Transferase level >150IU/L)
    15. Significant cardiomyopathy (Left ventricular ejection fraction <30%)
    16. Greater than 2 seizures during the 12 months prior to study entry
    17. Requiring fertility treatment
    18. Any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial (e.g. severe chronic lung disease, terminal illness)
    19. Previous randomisation into this study
    20. Concurrent participation in another clinical trial
    21. Participation in another clinical trial during the twelve weeks prior to study entry (i.e. screening visit)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change in the concentration of serum C Reactive Protein after twelve weeks as measured by the Roche® Cobas immuno-turbidimetric test on the Roche® platform.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No treatment
    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 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
    The trial will end when the last research participant completes his last visit.
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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) Yes
    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 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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)
    Treatment of research participants will not be different from the expected normal treatment after the research participant has ended his participation in the trial. Research participants will be outpatients of the Endocrinology service in St Columcille’s Hospital and will be free to contact healthcare professionals working within this unit should they so need.
    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 Decision2010-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-09-04
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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