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    Summary
    EudraCT Number:2012-004866-16
    Sponsor's Protocol Code Number:I5E-MC-TSAT
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-004866-16
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Parallel Study with an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in men with low testosterone to measure the effect of testosterone solution on testosterone levels, sex drive and energy.
    A.4.1Sponsor's protocol code numberI5E-MC-TSAT
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1136-0915
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.com
    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 No
    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 nameTestosterone Solution
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE
    D.3.9.3Other descriptive nameTestosterone solution
    D.3.9.4EV Substance CodeSUB10937MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCutaneous solution
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Male hypogonadism
    E.1.1.1Medical condition in easily understood language
    Low testosterone levels in men.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021011
    E.1.2Term Hypogonadism male
    E.1.2System Organ Class 10014698 - Endocrine disorders
    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 double blind phase is to compare the effect of testosterone solution vs. placebo on the proportion of hypogonadal men having a serum total testosterone concentration within the normal range (300 – 1050 ng/dL) at the completion of 12 weeks of treatment.

    The primary objective of the open-label extension phase is to assess the safety of testosterone solution for an additional 24 weeks in hypogonadal men using the following measures:
    • Adverse events
    • Clinical laboratory tests (including hematocrit)
    • Prostate safety (prostate specific antigen [PSA] and digital rectal exam)
    • International Prostate Symptom Score (IPSS)
    E.2.2Secondary objectives of the trial
    The secondary objectives of the double-blind phase are:
    a) In patients with low sex drive, assess and compare the impact of testosterone solution vs. placebo on levels of sexual arousal, interest, and drive, as measured by change from baseline in scores on the Sexual Arousal, Interest, and Drive (SAID) Scale.
    b) In patients with low energy, assess and compare the impact of testosterone solution vs. placebo on levels of energy as measured by change from baseline in scores on the Hypogonadism Energy Diary (HED).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Able to read, understand, and provide signed informed consent before starting trial activities related to Study TSAT (including discontinuing [washout] testosterone replacement therapy or other therapies prior screening).
    [2] Male at least 18 years of age at the time of screening.
    [3] Total testosterone level <300ng/dL (10.4 nmol/L) obtained at each of the 2 screening visits, performed at least 1 week apart (morning lab collection required between 0700 and 1100 hours).
    [4] Currently have at least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive, based on patient reported history and opinion of the investigator.
    [5] If the individual is taking lipid-lowering medications, insulin, antidepressants, anxiolytics, or therapy for benign prostatic hyperplasia (BPH), their dose must be stable for at least 3 months prior to screening in the opinion of the investigator.
    [6] PSA <4 ng/ml at the time of screening.
    [7] Agree to not start any new medication for erectile dysfunction (ED) or libido during the study at any point from screening to the end of the double-blind portion of the study (including herbal and over-the-counter medications).
    [8] If the individual is receiving testosterone replacement therapy and is willing to discontinue testosterone replacement therapy to enter the study, their screening testosterone level cannot be checked until at least 14 days after discontinuing oral or topical therapies (or at least 30 days for patients using short-acting intramuscular [IM] therapies [testosterone cypionate or testosterone enanthate] or at least 6 months for patients using long-acting IM testosterone undecanoate).
    E.4Principal exclusion criteria
    [1] Sexual partner who is, or becomes, pregnant at any time during the study.
    [2] Use of long-acting IM testosterone undecanoate or testosterone pellets in the 6-month period prior to screening.
    [3] BMI >37kg/m2 at screening.
    [4] Severe lower urinary tract symptoms as well as significant prostate enlargement to the extent that the investigator does not believe that the patient should receive testosterone replacement therapy.
    [5] Prolactin lab test result of >30 ng/dL at screening.
    [6] HbA1c >11% at screening.
    [7] Hematocrit ≥50% at screening. For sites located at geographic elevations ≥4500 feet (approximately 1370 meters), patients will be excluded with hematocrit >54% at screening, according to investigator discretion. If any patient at any site regardless of geographic elevation develops hematocrit >54% at later study visits investigational product will be discontinued immediately.
    [8] Significant history of allergy and/or sensitivity to the drug products or excipients, including any history of sensitivity to testosterone and/or sunscreens.
    [9] Current use of any medications, herbal, and/or nutritional supplements that can interfere with testosterone.
    [10] Dermatologic condition in underarm area that might interfere with testosterone absorption or be exacerbated by topical testosterone replacement therapy.
    [11] Currently receiving treatment with cancer chemotherapy or antiandrogens.
    [12] Current use of systemic glucocorticoids. Use of non-testosterone anabolic steroids within 12 months prior to screening.
    [13] Competitive athletes involved in a sport in which they may be screened for anabolic steroids.
    [14] History of use of estrogenizing agents within 12 months prior to screening.
    [15] History of luteinizing hormone-releasing hormone antagonist or agonist treatment in the last 6 months prior to screening.
    [16] History of clomiphene or other anti-estrogen treatment in the 3 months prior to screening.
    [17] Use of finasteride within 3 months prior to screening, or use of dutasteride within 6 months prior to screening.
    [18] Current use of warfarin.
    [19] History of frequent opioid use (>1 time/week) within 30 days prior to screening.
    [20] Current use of dopamine receptor agonists (cabergoline, pergolide, bromocriptine).
    [21] History of drug, alcohol, or substance abuse within 6 months prior to screening, as assessed by the investigator.
    [22] Have a history of significant central nervous system injuries or disease within 6 months prior to screening.
    [23] Exhibit systolic blood pressure >170 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at screening, or have history of malignant hypertension.
    [24] History of unstable angina or angina occurring during sexual intercourse in the last 6 months.
    [25] History of any of the following coronary conditions within 90 days of screening:
    a. myocardial infarction
    b. coronary artery bypass graft surgery
    c. percutaneous coronary intervention (angioplasty or stent placement)
    [26] Have any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 beats per minute [bpm]) at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for ≥30 seconds), or use an automatic internal cardioverter-defibrillator.
    [27] Have a history of sudden cardiac arrest.
    [28] Exhibit any evidence of congestive heart failure within 6 months prior to screening.
    [29] Have had a new, significant cardiac conduction defect within 90 days prior to screening.
    [30] Clinical suspicion (or history) of prostate cancer during digital rectal examination at the time of screening.
    [31] Known or suspected breast cancer (or history of breast cancer) or other active cancer (with the exception of nonmelanotic skin cancer).
    [32] Exhibit evidence of severe renal impairment at the time of screening.
    [33] Exhibit a history of severe liver disease or clinical evidence of hepatic impairment at the time of screening.
    [34] Have a history of human immunodeficiency virus (HIV) infection or a sexually transmitted disease.
    [35] Severe sleep apnea (untreated or unsuccessfully treated) in the opinion of the study investigator.
    [36] Untreated hypothyroidism, hypercortisolism or other significant endocrinopathy (other than hypogonadism) that, in the opinion of the investigator, contributes to symptoms of low energy or fatigue.

    Additionally for the open-label extension phase:
    [37] Any clinically significant chronic illness or finding and/or laboratory results that would interfere with the trial objectives or safety of the patient.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the double blind phase is to determine the proportion of men that have a serum total testosterone level within the normal range (300 – 1050 ng/dL) at the completion of 12 weeks of treatment with testosterone solution.

    The primary endpoint of the open-label extension is to assess long term safety by collecting the following measures:
    • Adverse events
    • Clinical laboratory tests (including hematocrit)
    • Prostate safety (prostate specific antigen [PSA] and digital rectal exam)
    • International Prostate Symptom Score (IPSS)
    at the completion of the additional 24 weeks of treatment with testosterone solution . The measures will be compared to the baseline visit of the double-blind phase and the baseline visit of the open-label extension phase.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Double blind phase:
    12 weeks of treatment

    Open-label extension phase:
    Total of 36 weeks of treatment (12 weeks treatment during double-blind phase + 24 weeks treatment during open-label extension)
    E.5.2Secondary end point(s)
    The secondary endpoints of the double blind phase are:

    1. In patients with low sex drive, the change in levels of sexual arousal, interest and drive as assessed by a patient reported outcome tool, the SAID (Sexual Arousal, Interest and Drive) Scale at the completion of 12 weeks of treatment with testosterone solution.
    2. In patients with low energy, the change in energy level as assessed by a patient reported outcome tool, the HED (Hypogonadism Energy Diary) at the completion of 12 weeks of treatment with testosterone solution.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 4 weeks of treatment

    2. 12 weeks of treatment
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Open label extension phase
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Canada
    Germany
    Italy
    Korea, Republic of
    Puerto Rico
    Spain
    Russian Federation
    United Kingdom
    United States
    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 years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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.1.2.1Number of subjects for this age range: 525
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 93
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 618
    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)
    Standard of 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 Decision2013-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-30
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