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    Summary
    EudraCT Number:2007-007670-38
    Sponsor's Protocol Code Number:L00074-TD401
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-05-05
    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 number2007-007670-38
    A.3Full title of the trial
    "Evaluation of erectyle disfonction in patients suffering from testosterone deficiency, before and after tretament by Testopatch"
    A.4.1Sponsor's protocol code numberL00074-TD401
    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 SponsorPierre Fabre Médicament
    B.1.3.4CountryFrance
    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 Testopatch
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Médicament
    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 Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal 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) 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 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 CIALIS
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.11 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 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 placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Testosterone deficiency
    Erectile dysfunction
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061461
    E.1.2Term Erectile dysfunction
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10058359
    E.1.2Term Hypogonadism
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of testosterone supplementation with Testopatch® in hypogonadal patients complaining of erectile dysfunction.
    E.2.2Secondary objectives of the trial
     To assess the effects of testosterone supplementation on sexual desire,
     To assess the effects of testosterone supplementation on quality of life,
     To document the interest of the combination of Testopatch® with PDE
    5 inhibitor (tadalafil) in patients complaining of erectile dysfunction,
     To assess the interest of plasma testosterone assays in the aetiology of
    patients with erectile dysfunction.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Men over 18 years old,
     With a history of ED (defined as the inability to achieve or maintain an erection sufficient to permit satisfying sexual performance) for at least three months,
     Erectile function (EF) domain score of the International Index of Erectile Function (IIEF) < 21,
     Body-mass index (BMI)  32 kg/m2,
     Serum total testosterone (TT) < 3.46 ng/mL (12 nmol/L ) or bioavailable testosterone (BT) < 0.8 ng/mL (2.3 nmol/L) confirmed on 2 blood samples collected on 2 different days between 7 - 11a.m.,
     Never treated for testosterone deficiency or have not received testosterone treatment within the last year,
     Never treated for ED with a PDE5 inhibitor or not treated for at least 3 months,
     Who agree to have at least two sexual intercourse attempts during the selection period, and an average of one sexual intercourse attempt weekly during the study period,
     Who agree not to use any other treatment for ED during the study period (including vacuum and herbal therapies),
     Having signed their written informed consent,
     Well-informed of the study procedures, cooperative with regard to compliance with study related constraints,
     Patient’s health care covered by Social Security or medical health insurance.
    E.4Principal exclusion criteria
    Criteria related to pathologies
     Penile prosthesis, significant congenital or acquired penile deformation, or any organic aetiology,
     Hyperprolactinemia defined as serum prolactin >50 ng/mL,
     Severe depression ,
     Benign prostate hyperplasia with severe lower urinary tract symptoms as defined by an International Prostate Symptom Score (IPSS) >19,
     History of prostate or breast cancer,
     Known acute or chronic prostate pathology, and/or PSA > 2 ng/mL, and/or suspicion of prostate cancer,
     Presence or history of liver tumour,
     Severe hepatic, renal or respiratory failure,
     Congestive heart failure (NYHA class II, III or IV),
     Myocardial infarction within the three months preceding inclusion,
     Unstable angina or angina occurring during sexual intercourse,
     Uncontrolled arrhythmia, hypotension (< 90/50 mm Hg), or uncontrolled hypertension (> 140/90 mm Hg),
     Epilepsy, or migraine , or any organic cerebral disease; stroke within the last 6 months,
     Known sleep apnoea or risk factors for sleep apnoea (obesity, chronic respiratory disease),
     Any severe systemic disease,
     Generalised skin disorders (hypertrichosis, psoriasis, eczema),
     Uncontrolled diabetes with a blood level of HbA1c ≥ 8%,
     Untreated dyslipidaemia,
     Hematocrit > 50%,
     Unexplained, clinically significant abnormality in blood cell count,
     Positive serology to HIV antibodies, HCV antibodies and/or HBs surface antigen,
     AST, ALT or GT value more than 2.5 times the upper limit of normal range.

    * Criteria related to treatments
     Known hypersensitivity to testosterone or any other patch component,
     Other concomitant patch treatment or other androgen replacement therapy including dehydroepiandrosterone (DHEA),
     Concomitant treatment with barbiturates, spironolactone, anticoagulants, insulin, 5-reductase inhibitors, anti-androgens, LH-RH analogues, corticosteroids used topically or as immunosuppressant,
     Concomitant treatment with -blockers or any form of organic nitrate,
     Concomitant treatment with potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin),
     Erectile dysfunction known to be due to prescription medications,
     Any concomitant treatment influencing erection (antipsychotics, antidepressants, blockers, fibrates, …),
     Patient who has received blood or plasma derivatives in the year preceding the study,
     Known hypersensitivity to tadalafil (Cialis®), or to any of the excipients,
     Contraindication with tadalafil (Cialis®)
    E.5 End points
    E.5.1Primary end point(s)
    Changes from baseline in the EF domain score of the IIEF at Week 12.
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 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
    Last visit of the last subject.
    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 months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 104
    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)
    After stopping study medication, at the end of the study, the patient will continue his testosterone supplement treatment, if applicable, with his usual physician. If the PSA total value is elevated at the end of the study, the patient will be sent to an urologist.
    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 Decision2008-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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