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    Summary
    EudraCT Number:2019-004599-20
    Sponsor's Protocol Code Number:PHRCN_2018_BACHOUMAS
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-05-25
    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 number2019-004599-20
    A.3Full title of the trial
    Effects of early testosterone gel administration on physical performance in the critically ill: a randomised double blind clinical trial
    Evaluation de l’efficacité de la testostérone en gel administrée précocement en
    réanimation sur la performance physique : étude multicentrique randomisée contrôlée
    en double aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of early testosterone gel administration on physical performance in the critically ill
    Evaluation de l’efficacité de la testostérone en gel administrée précocement en
    réanimation sur la performance physique
    A.3.2Name or abbreviated title of the trial where available
    TestICUs
    A.4.1Sponsor's protocol code numberPHRCN_2018_BACHOUMAS
    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 supportMinsitère de la Santé
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-Ferrand
    B.5.2Functional name of contact pointDirection de la Recherche Clinique
    B.5.3 Address:
    B.5.3.1Street Address58 rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number330473751195
    B.5.5Fax number330473754730
    B.5.6E-mailpromo_interne_drci@chu-clermontferrand.fr
    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 Androgel
    D.2.1.1.2Name of the Marketing Authorisation holderBesins Healthcare
    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
    D.3.4Pharmaceutical form Gel
    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.3.9.4EV Substance CodeSUB10937MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16.2
    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.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 placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients receiving invasive mechanical ventilation and treatment with a vasoactive drug within 96 hours of ICU admission will be screened.
    E.1.1.1Medical condition in easily understood language
    Patients receiving invasive mechanical ventilation and treatment with a vasoactive drug within 96 hours of ICU admission will be screened.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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 daily administration of testosterone gel, 101.25 mg in men and 20.25 mg in women, during the acute phase of critical illness, is more effective than placebo in improving physical performance 3 months after ICU admission.
    E.2.2Secondary objectives of the trial
    To demonstrate that daily administration of testosterone gel 101.25 mg in men and 20.25 in women, during the acute phase of critical illness is more effective than placebo in:

    • Improving physical performance
    • Increasing muscle strength
    • Improving functional status
    • Improving oxygen muscular consumption
    • Decreasing hospitalization rate
    • Decreasing duration of hospital admissions

    To evaluate the impact of testosterone gel on:


    • Duration of invasive mechanical ventilation
    • Ventilator-associated pneumonia rate
    • Bloodstream infection rate
    • Length of stay in the ICU
    • Length of stay in hospital
    • Mortality rate at 28 days after ICU admission
    • Mortality rate at 90 days after ICU admission
    • Hospital mortality rate
    • ICU mortality rate

    To assess the safety of testosterone gel in critically ill patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Males and females aged over 18 years
    • COVID-19 or not
    • Invasive mechanical ventilation expected to be required for more than 48 hours
    • Written informed consent obtained from the patient or the legal representative
    E.4Principal exclusion criteria
    • History of prostate cancer
    • History of breast cancer
    • PSA ≥ 4 ng/ml
    • ICU length of stay > 120 h before enrollment
    • Moribund
    • Pre-existing illness with a life expectancy of <6 months
    • Recent intracranial or spinal cord injury (< 1 month)
    • Recent hemorrhagic or ischemic stroke( < 1 month)
    • Neuromuscular disease
    • Cardiac arrest in non-shockable rhythm
    • Pre-existing cognitive impairment or language barrier
    • 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
    • Breast feeding
    • Patients under legal guardianship
    E.5 End points
    E.5.1Primary end point(s)
    • Physical performance 3 months after ICU admission assessed by the 6-minute-walk distance test (6MWD) in metres.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months after ICU admission
    E.5.2Secondary end point(s)
    • Physical performance 3, 6 months and 1 year after ICU admission

     6 MWD at 6 months and 1 year
     6 MWD in metres at 6 months and 1 year
     Percentage of patients with increase of 30 m between 2 assessments
     Percentage of patients with 6 MWD at 6 months > 60% the distance walked in an age-matched and sex-matched control population (14,78)
     Percentage of patients with 6 MWD at 1 year > 65% the distance walked in an age-matched and sex-matched control population (14,78)
     Percentage of patients with Short Physical Performance Battery < 10 at 3, 6 months and 1 year
     Physical component of SF 36 (Medical Outcomes Study 36 Item Short Form Health Survey) at 3, 6 months and 1 year (appendix 3)

    • Muscle strength on ICU discharge at 3, 6 months and 1 year after ICU admission

     Handgrip: Kg and percentage of the predicted force
     MRC (appendix 4)

    • Muscle mass at 3, 6 and 1 year after ICU admission

     MAMC

    • Functional status at 3, 6 months and 1 year after ICU admission

     Composite score of 11 items of ADL and IADL (appendices 5 and 6)

    • Oxygen muscular consumption at ICU discharge and at 3 months after ICU admission

    • Hospitalization rate at 3, 6 months and 1 year after ICU admission
    • Duration of new hospitalisation at 3, 6 months and 1 year after ICU admission
    • Ventilation free days at day 28
    • Ventilator-associated pneumonia rate
    • Nosocomial infections rate
    • Length of stay in the ICU
    • Length of stay in hospital
    • Mortality rate at day 28
    • Mortality rate at day 90
    • ICU mortality rate
    • Hospital mortality rate

    • Safety of testosterone gel
     Hypertension
     Cardiovascular ischemic events (Appendix 8) (64)
     Obstructive sleep apnea
     Increase in hemoglobin, hematocrit and red blood cells counts
     Alopecia, urticaria, acne, erythema
     Vertigo, paresthesia
     Depression, anxiety
     Gynaecomastia
     Oedema, weight gain
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6 months and 1 year after ICU admission
    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 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 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 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 concerned20
    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 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
    Period of inclusion: 2 years
    Provisional end of study: one year after inclusion of the last patient

    End of study : Last Visit Last Patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    An informed, written and freely given consent will be requested. The patient or the patient’s legal representative will be allowed the time they require to make a decision.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state600
    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)
    NA
    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 Decision2021-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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