E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Testosterone deficiency Erectile dysfunction |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061461 |
E.1.2 | Term | Erectile dysfunction |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058359 |
E.1.2 | Term | Hypogonadism |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect of testosterone supplementation with Testopatch® in hypogonadal patients complaining of erectile dysfunction.
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E.2.2 | Secondary 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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®)
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes from baseline in the EF domain score of the IIEF at Week 12. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | 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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial 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
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Last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |