Mild to moderate erectile dysfunction MedDRA version: 11.1 Level: LLT Classification code 10061461 Term:
Conditions
Sponsors
sanofi-aventis recherche et développement
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male patient with history of mild to moderate erectile dysfunction =6 months according to the National Institutes of Health Consensus Statement definition - Having given written informed consent prior to any procedure related to the study. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Related to study methodology at screening : -Age 60 years -Patient without a self-reported erection under visual sexual simulation in the past 6 months -Vital signs at screening outside the following range, after 10 min resting in supine position: • 100 mmHg5.30 µU/ml -Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, testicular, ocular or infectious disease, any acute infectious disease or signs of acute illness -Any treatment for depression, psychiatric disorders, substance abuse, anxiety disorders, investigational drug within 3 months prior to inclusion -Nitrates, Nitric Oxide donors, androgens or beta-androgens, trazodone -Beta blockers for hypertension or other chronic medical condition are authorized if dose has been stable for at least 1 month prior to screening for the study and use has not been associated with orthostatic symptoms and blood pressure is stable. Additional exclusion criteria related to study methodology at randomization visit : -Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies -Positive results on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates) -Positive alcohol breath test (as an indication of alcohol use) Exclusion criteria related to SAR407889A : -Any history of severe orthostatic dysregulation (neurocardiogenic syncope, postural orthostatic tachycardia syndrome) -Patients with partners of childbearing potential or whose partners are pregnant or lactating or not willing to use an effective method of contraception during the study and for 7 weeks after the end of study visit (eg, condom associated with spermicide plus occlusive cap). Exclusion criteria related to sildenafil : -Hypersensitivity to PDE5 inhibitor -Men with cardiac disease for whom sexual activity is inadvisable -Patients with myocardial infarction within the last 90 days -Patients with unstable angina or angina occurring during sexual intercourse -Patients with New York Heart Association Class 2 or greater heart failure in the last 6 months -Patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension -Patients with a stroke within the last 6 months -Loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure -Use of an alpha-1 blocker -Us
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine and compare the effect of SAR407899A versus placebo after single dose administration, in patients suffering from mild to moderate erectile dysfunction, on the duration of penile rigidity (>60% at the base of the penis as assessed by the RigiScan® Plus Rigidity and Tumescence monitor) during visual sexual stimulation.;Secondary Objective: To determine and compare the effect of SAR407899A versus placebo and sildenafil on several other characteristics of the erection as assessed by the RigiScan® Plus Rigidity and Tumescence monitor during visual sexual stimulation: - duration of penile rigidity >60% at the tip of the penis - duration of penile rigidity >80% at the base and the tip of the penis - Time to onset of penile tumescence (change in circumference). Sildenafil will be used as a calibrator to document the sensitivity of the experimental conditions. Overall safety will be also be assessed and include specific monitoring of effects on blood pressure.;Primary end point(s): Duration of penile rigidity >60% assessed by RigiScan® Plus at the base of the penis | — |
Countries
France
Outcome results
None listed