Evaluation of erectyle disfonction in patients suffering from testosterone deficiency, before and after tretament by Testopatch

• Conditions: Testosterone deficiencyErectile dysfunction; MedDRA version: 9.1Level: LLTClassification code 10061461Term: Erectile dysfunction; MedDRA version: 9.1Level: LLTClassification code 10058359Term: Hypogonadism

• Registration Number: EUCTR2007-007670-38-FR
• Lead Sponsor: Pierre Fabre Médicament

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 104

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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®)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of testosterone supplementation with Testopatch® in hypogonadal patients complaining of erectile dysfunction.<br>;Secondary Objective: ?To assess the effects of testosterone supplementation on sexual desire,<br>?To assess the effects of testosterone supplementation on quality of life,<br>?To document the interest of the combination of Testopatch® with PDE<br> 5 inhibitor (tadalafil) in patients complaining of erectile dysfunction,<br>?To assess the interest of plasma testosterone assays in the aetiology of<br> patients with erectile dysfunction.<br><br>;Primary end point(s): Changes from baseline in the EF domain score of the IIEF at Week 12.