E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderate erectile dysfunction |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 11.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061461 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal exclusion criteria |
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<systolic blood pressure<140 mmHg • 45 mmHg<diastolic blood pressure<90 mmHg • 40 bpm<heart rate<100 bpm -Abnormal standard 12-lead ECG after 10 min resting in supine position at screening; 120 ms<PR<220 ms, QRS <120 ms, QTc ≤450 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 -Use of any form of organic nitrate is contra-indicated -Use of a potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) -Use of a CYP3A4 inducer such as rifampicin |
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E.5 End points |
E.5.1 | Primary end point(s) |
Duration of penile rigidity >60% assessed by RigiScan® Plus at the base of the penis |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |