Randomized, double-blind, placebo and active controlled study of the activity ofSAR407899A single-dose on the ability to increase duration of penile rigidity,under experimental condition, in patients with mild to moderate erectiledysfunction - RHOKET
- Conditions
- Mild to moderate erectile dysfunctionMedDRA version: 11.1Level: LLTClassification code 10061461Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2009-009936-56-FR
- Lead Sponsor
- sanofi-aventis recherche et développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 24
- 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
Related to study methodology at screening :
-Age <18 years or >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 mmHg• 45 mmHg• 40 bpm-Abnormal standard 12-lead ECG after 10 min resting in supine position at screening;
120 ms-Laboratory parameters outside the normal range unless the Investigator considers an abnormality as clinically not relevant for these patients. Hepatic enzymes (AST, ALT) should be strictly below 3 upper laboratory norms.
-Any clinical penile abnormality that does not allow proper fit of the RigiScan® Plus
device
-Contact dermatitis
-Non responders to PDE5 inhibitor(s): defined as less than 50% of successful attempts for at least 6 months
-History of radical prostatectomy
-Diabetes mellitus
-Hypogonadal testosterone levels (<300 ng/dl)
-TSH levels <0.30 µU/ml or >5.30 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method