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    Summary
    EudraCT Number:2017-004978-34
    Sponsor's Protocol Code Number:RBHP2017BACHOUMAS
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-03
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-004978-34
    A.3Full title of the trial
    Efficacy of Testosterone gel to restore normal serum values of testosterone during the acute phase of critical illness in adult ICU patients. An open-label parallel randomized controlled pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Testosterone gel to restore normal serum values of testosterone during the acute phase of critical illness in adult ICU patients
    A.3.2Name or abbreviated title of the trial where available
    TestICU-1
    A.4.1Sponsor's protocol code numberRBHP2017BACHOUMAS
    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 SponsorCHU de Clermont-ferrand
    B.1.3.4CountryFrance
    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 supportLabel I-SITE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDRCI
    B.5.2Functional name of contact pointPatrick Lacarin
    B.5.3 Address:
    B.5.3.1Street Address58 rue Montalemenert
    B.5.3.2Town/ cityClermont-ferrand
    B.5.3.3Post code63003
    B.5.3.4CountryFrance
    B.5.4Telephone number00330473751195
    B.5.5Fax number00330473754730
    B.5.6E-mailplacarin@chu-clermontferrand.fr
    D. IMP Identification
    D.IMP: 1
    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 No
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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.IMP: 2
    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 Androgel 16.2 mg/g is a transparent or slightly opalescent, colourless gel with an odour of alcohol. One gram of gel contains 16.2 mg testosterone. One pump actuation delivers 1.25 g of gel containing 20.25 mg of testosterone.
    D.2.1.1.2Name of the Marketing Authorisation holderAndrogel 16.2mg/g
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAndrogel® 1.62 mg/L
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    - Hypermetabolism in ICU, loss of muscle mass and functional disability after ICU
    - ICU acquired hypogonadism
    - Treatment with testosterone gel in ICU
    E.1.1.1Medical condition in easily understood language
    - Hypermetabolism in ICU, loss of muscle mass and functional disability after ICU
    - ICU acquired hypogonadism
    - Treatment with testosterone gel in ICU
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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 demonstrate that administration of 101.25 mg/day of testosterone gel in men and 20.25 mg/day in women, during the acute phase of critical illness, can restore normal serum values of total testosterone from day 4 to day 14.
    E.2.2Secondary objectives of the trial
    • Proportion of patients with median free testosterone serum values at day 4, 7, 10, 14 higher than 58 pg/ml in men and 0,9 ng/ml in women
    • Proportion of patients with median serum values of bioavailable testosterone at day 4, 7, 10, 14 higher than 75 ng/dl in men 0.8 ng/dl in women
    • Safety of testosterone gel
    • Daily and cumulative nitrogen balance from day 1 to extubation
    • Physical performance at ICU discharge, 1month and 3 months after ICU discharge
    • Muscle strength at ICU discharge, 1month and 3 months after ICU discharge
    • Near Infrared Spectroscopy (NIRS) at ICU discharge
    • Muscular mass at ICU discharge and one month after ICU discharge
    • Lung function at 1 and 3 months after ICU discharge
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Males and females aged over 18 years receiving invasive mechanical ventilation
    - Invasive mechanical ventilation expected to be required for more than 48 hours
    - Treatment with vasoactive drugs
    - Written informed consent obtained from the legal representative
    - Social security cover
    E.4Principal exclusion criteria
    • History of prostate or breast cancer, prostatic specific antigen (PSA) ≥ 4 ng/ml
    • ICU length of stay > 72 h before enrollment
    • Moribund defined as having a score SAPS II > 75 12 hours after admission
    • Pre-existing illness with a life expectancy of <6 months
    • Cardiac arrest
    • Preexistent cognitive impairment or language barrier
    • Acute intracranial or spinal cord injury
    • Acute hemorrhagic or ischemic stroke
    • Neuromuscular disease (Guillain-Barré, myasthenia)
    • Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not excluded)
    • Documented allergy to testosterone
    • Age > 80 years
    • Pregnancy or breast feeding
    • Patient under legal guardianship
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of patients with median value of serum total testosterone collected from blood samples at day 4, 7, 10, 14 higher than 280 ng/dl in men and 12 ng/dl in women.
    E.5.1.1Timepoint(s) of evaluation of this end point
    from day 4 to day 14 after inclusion
    E.5.2Secondary end point(s)
    • Proportion of patients with median free testosterone serum values at day 4, 7, 10, 14 higher than 58 pg/ml in men and 0,9 ng/ml in women
    • Proportion of patients with median serum values of bioavailable testosterone at day 4, 7, 10, 14 higher than 75 ng/dl in men 0.8 ng/dl in women
    • Safety of testosterone gel
    • Daily and cumulative nitrogen balance from day 1 to extubation
    • Physical performance at ICU discharge, 1month and 3 months after ICU discharge
    • Muscle strength at ICU discharge, 1month and 3 months after ICU discharge
    • Near Infrared Spectroscopy (NIRS) at ICU discharge
    • Muscular mass at ICU discharge and one month after ICU discharge
    • Lung function at 1 and 3 months after ICU discharge
    E.5.2.1Timepoint(s) of evaluation of this end point
    at day 4, 7, 10, 14 higher than 58 pg/ml in men and 0,9 ng/ml in women
    • Proportion of patients with median serum values of bioavailable testosterone
    • throughout the duration of the study
    • day 1 to extubation
    • at ICU discharge, 1month and 3 months after ICU discharge
    • at ICU discharge, 1month and 3 months after ICU discharge
    at ICU discharge
    • at ICU discharge and one month after ICU discharge
    • at 1 and 3 months after ICU discharge
    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 No
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    In the control group, AndroGel will not be administered.
    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 duration of the study extends from the inclusion until 3 months after ICU discharge.
    The study will be interrupted for the following reasons:

    • Withdrawal of consent: when a subject withdraws consent before completing the study, the reason for withdrawal of consent is to be documented on the eCRF and in the source document.
    • Adverse experiences
    • At the request of the investigator or sponsor, whether for administrative or other reasons




    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 months18
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    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 state30
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-01
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