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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-007670-38-FR
• Date of registration: 05/05/2008
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Médicament
• Public title: "Evaluation of erectyle disfonction in patients suffering from testosterone deficiency, before and after tretament by Testopatch"
• Scientific title: "Evaluation of erectyle disfonction in patients suffering from testosterone deficiency, before and after tretament by Testopatch"
• Date of first enrolment: 23/06/2008
• Target sample size: 104
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007670-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

France

Key inclusion & exclusion 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) < 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®)



Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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
Pharmaceutical Form: Film-coated tablet

Primary Outcome(s)

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.

Main Objective: To evaluate the effect of testosterone supplementation with Testopatch® in hypogonadal patients complaining of erectile dysfunction.

Primary end point(s): Changes from baseline in the EF domain score of the IIEF at Week 12.

Secondary ID(s)

L00074-TD401