Testosterone deficiency Erectile dysfunction MedDRA version: 9.1 Level: LLT Classification code 10061461 Term: Erectile dysfunction MedDRA version: 9.1 Level: LLT Classification code 10058359 Term: Hypogonadism
Conditions
Interventions
Trade Name: Testopatch
Pharmaceutical Form: Transdermal patch
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use
Trade Name: CIALIS
Pharmace
Sponsors
Pierre Fabre Médicament
Eligibility
Sex/Gender
Male
Inclusion criteria
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) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 ( 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®)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of testosterone supplementation with Testopatch® in hypogonadal patients complaining of erectile dysfunction. ;Secondary Objective: ? 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. ;Primary end point(s): Changes from baseline in the EF domain score of the IIEF at Week 12. | — |
Countries
France
Outcome results
None listed