Erectile Dysfunction Clinical Trial
— RHOKETOfficial title:
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).
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | October 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Sanofi-Aventis Administrative Office | Paris |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of penile rigidity during sexual stimulation | 4 hours following drug administration | No | |
Secondary | Time to onset of penile rigidity | 4 hours following drug administration | No | |
Secondary | Blood pressure | 12 hours following drug administration | Yes |
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