SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction
NCT ID: NCT00914277
Last Updated: 2011-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2009-05-31
2009-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Sequence 1
Period 1: placebo
Period 2: sildenafil
Period 3: SAR407899 dose level 2
Period 4: SAR407899 dose level 1
SAR407899
Oral administration
Placebo
Oral administration
Sildenafil
Oral administration
Sequence 2
Period 1: sildenafil
Period 2: SAR407899 dose level 1
Period 3: placebo
Period 4: SAR407899 dose level 2
SAR407899
Oral administration
Placebo
Oral administration
Sildenafil
Oral administration
Sequence 3
Period 1: SAR407899 dose level 1
Period 2: SAR407899 dose level 2
Period 3: sildenafil
Period 4: placebo
SAR407899
Oral administration
Placebo
Oral administration
Sildenafil
Oral administration
Sequence 4
Period 1: SAR407899 dose level 2
Period 2: placebo
Period 3: SAR407899 dose level 1
Period 4: sildenafil
SAR407899
Oral administration
Placebo
Oral administration
Sildenafil
Oral administration
Interventions
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SAR407899
Oral administration
Placebo
Oral administration
Sildenafil
Oral administration
Eligibility Criteria
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Inclusion Criteria
* written informed consent
Exclusion Criteria
* 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.
18 Years
60 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Lionel HOVSEPIAN, MD
Role: PRINCIPAL_INVESTIGATOR
SGS Aster Life Science Services - Paris-France
Locations
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Sanofi-Aventis Administrative Office
Paris, , France
Countries
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Other Identifiers
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EudraCT:2009-009936-56
Identifier Type: -
Identifier Source: secondary_id
ACT10775
Identifier Type: -
Identifier Source: org_study_id
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