Erectile Dysfunction
Conditions
Keywords
Rho-kinase inhibitor, male impotence
Brief summary
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.
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of penile rigidity during sexual stimulation | 4 hours following drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset of penile rigidity | 4 hours following drug administration |
| Blood pressure | 12 hours following drug administration |
Countries
France
Outcome results
None listed