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    Summary
    EudraCT Number:2005-002607-17
    Sponsor's Protocol Code Number:TSX/01/C
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-19
    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 ConcernedSweden - MPA
    A.2EudraCT number2005-002607-17
    A.3Full title of the trial
    Effect of Transdermal Testosterone Replacement in Hypogonadal Men with either Metabolic Syndrome or Type 2 Diabetes Mellitus
    A.3.2Name or abbreviated title of the trial where available
    TIMES 2
    A.4.1Sponsor's protocol code numberTSX/01/C
    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 SponsorProstrakan Pharmaceuticals Ltd
    B.1.3.4CountryUnited Kingdom
    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 Tostrex 2% gel
    D.2.1.1.2Name of the Marketing Authorisation holderStrakan Limited
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameTostrex
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTestosterone
    D.3.9.1CAS number 58-22-0
    D.3.9.3Other descriptive name17β-Hydroxyandrost-4-en-3-one
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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 typePharmacotherapeutic group: Androgen
    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 placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Male hypogonadism is generally characterised by abnormally low serum testosterone levels. Symptoms include changes in mood, decreased bone mineral density, increased body fat, decreased muscle mass and strength and sexual dysfunction. A number of conditions can also be associated with decreased testosterone production including metabolic syndrome, type II diabetes mellitus, atherosclerosis, myocardial infarction and chronic heart failure
    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
    The primary objectives of this study are to determine the effect of Tostrex® 2% gel on insulin resistance in hypogonadal patients with metabolic syndrome and/or type 2 diabetes mellitus after both 6 months and 1 year of testosterone replacement therapy (TRT).
    E.2.2Secondary objectives of the trial
    To assess the effect of Tostrex® 2% gel on change in abdominal obesity, lipid profile, glycaemic control and insulin sensitivity after 6 months and 1 year of treatment.
    To assess the effect of Tostrex® 2% gel on the change in symptoms of hypogonadism after 6 months and 1 year of treatment.
    To assess the effect of Tostrex® 2% gel in each disease specific subgroup of patients (i.e. metabolic syndrome or type 2 diabetes mellitus), on the change in abdominal obesity, lipid profile, glycaemic control and insulin sensitivity after 6 months and 1 year of treatment.
    To assess the effect of Tostrex® 2% gel on the change in Framingham Cardiovascular Risk Score and the number of cardiovascular events after 1 year of treatment.
    To assess the safety and tolerability of Tostrex® 2% gel compared to placebo gel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male patients aged at least 40 years old
    2. An early morning total testosterone level less than or equal to 11 nmol/L or calculated free testosterone levels less than or equal to 255 pmol/L, at least two separate timepoints, (between 08.00 - 10.00), at least one week apart.
    3. At least two symptoms of hypogonadism (e.g. decreased libido, erectile function, lean body mass or muscle mass; decrease in bone mineral density resulting in osteoporosis; depression, irritability and diminution of mental acuity; fatigue; and vasomotor symptoms, such as hot flushes)
    4. Metabolic syndrome as defined by the International Diabetes Federation (IDF):
    Central obesity (defined as a waist circumference greater than or equal to 94 cm for Europid men, with ethnicity specific values for other groups) and any two of the following four factors:
    (a) raised TG level: greater than or equal to 150 mg/dL (greater than or equal to 1.7 mmol/L), or specific treatment for this lipid abnormality
    (b) reduced HDL cholesterol: less than 40 mg/dL ess than 1.03 mmol/L in males, or specific treatment for this lipid abnormality
    (c) raised blood pressure: systolic BP greater than or equal to 130 mmHg or diastolic BP greater than or equal to 85 mmHg, or treatment of previously diagnosed hypertension
    (d) raised fasting plasma glucose (FPG) greater than or equal to 100 mg/dL (greater than or equal to 5.6 mmol/L), or previously diagnosed type 2 diabetes mellitus. If above 100 mg/dL or 5.6 mmol/L, an oral glucose tolerance test (OGTT) is strongly recommended but is not necessary to define presence of the syndrome.
    and/or type 2 diabetes mellitus as defined by:
    fasting plasma glucose (FPG) greater than or equal to 126 mg/dL (greater than or equal to 7.0 mmol/L) on two occasions or random glucose greater than or equal to 200 mg/dL (greater than or equal to 11.1 mmol/L) and classic symptoms of type 2 diabetes mellitus (polyuria, polydipsia, polyphagia, with / without weight loss) or previously diagnosed type 2 diabetes mellitus.
    E.4Principal exclusion criteria
    1. Treatment with testosterone replacement therapy within 6 months of randomisation
    2. Use of any other hormone manipulating therapy, or glucocorticoids and topical steroids (intranasal, inhaled or dermal) within 3 months of randomisation
    3. Insulin treated patients
    4. History of, or current prostate carcinoma
    5. Age-adjusted elevated PSA level
    6. Abnormal DRE of prostate, suggestive of cancer
    7. Severe symptomatic benign prostatic hyperplasia
    8. Patients actively or potentially trying to start a family or requiring fertility treatment
    9. Clinically significant hepatic, respiratory, haematological (haematocrit more than 52% at screening) or renal disease
    10. History of drug or alcohol abuse
    11. Receiving other trial drugs within 12 weeks
    12. Symptomatic obstructive sleep apnoea syndrome
    13. History or presence of male breast cancer
    14. Hyperprolactinaemia or pituitary tumour
    15. Any other reason, which the Investigator feels precludes safe inclusion of the patient.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable of this study is the change in insulin resistance as assessed by an ITT analysis at 6 months and 1 year as measured by the HOMA-IR.

    The secondary efficacy variables of this study are:
    1. Change in abdominal obesity as measured by changes in waist-hip ratio, percentage body fat, percentage lean mass, BMI and circumference of the waist from Baseline
    2. Change in lipid profile from Baseline
    3. Change in glycaemic control and insulin sensitivity as assessed by changes in insulin level, HbA1c and fasting glucose from Baseline
    4. Change in symptoms of hypogonadism as assessed by changes in AMS and IIEF scores from Baseline
    5. Change in Framingham Cardiovascular Risk Score
    6. A comparison will be made of the number of cardiovascular events in each treatment group occurring over the treatment period.

    Safety and tolerability end-points:

    1. Patient and Investigator assessments of local tolerability
    2. Adverse event (AE) incidence
    3. Changes in vital signs and laboratory parameters from Baseline to end of study.
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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) 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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 520
    F.4.2.2In the whole clinical trial 520
    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)
    Patient will receive standard therapy
    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 Decision2006-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-20
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