SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction

Study Overview
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Brief Summary
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The primary objective of this clinical trial is to study the ability of SAR407899 to increase the duration of penile erection in male patients with mild-moderate Erectile Dysfunction. The secondary objectives of this clinical trial are to study the ability of SAR407899 to shorten increase the time to erection duration of penile erection in male patients with mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of SAR407899 in these patients.

Official Title
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Randomized, Double-blind, Placebo and Active Controlled Study of the Activity of SAR407899A Single-dose on the Ability to Increase Duration of Penile Rigidity, Under Experimental Condition, in Patients With Mild to Moderate Erectile Dysfunction (ED).

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: SAR407899
* Drug: Placebo
* Drug: Sildenafil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male with mild to moderate erectile dysfunction for at least 6 months written informed consent Exclusion Criteria: diabetes mellitus orthostatic hypotension hypogonadal testosterone level The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Period 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1 | Drug: SAR407899<br>* Oral administration<br>Drug: Placebo<br>* Oral administration<br>Drug: Sildenafil<br>* Oral administration<br>|
| Experimental: Sequence 2<br>Period 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2 | Drug: SAR407899<br>* Oral administration<br>Drug: Placebo<br>* Oral administration<br>Drug: Sildenafil<br>* Oral administration<br>|
| Experimental: Sequence 3<br>Period 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo | Drug: SAR407899<br>* Oral administration<br>Drug: Placebo<br>* Oral administration<br>Drug: Sildenafil<br>* Oral administration<br>|
| Experimental: Sequence 4<br>Period 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil | Drug: SAR407899<br>* Oral administration<br>Drug: Placebo<br>* Oral administration<br>Drug: Sildenafil<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of penile rigidity during sexual stimulation |  | 4 hours following drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of penile rigidity |  | 4 hours following drug administration | 
| Blood pressure |  | 12 hours following drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rho-kinase inhibitor, male impotence