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

Phase 2

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: SAR407899; Drug: Placebo; Drug: Sildenafil

• Registration Number: NCT00914277
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-04
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-29
• Last Update Posted: 2011-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	Placebo	Period 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1
Sequence 2	Placebo	Period 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2
Sequence 2	Sildenafil	Period 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2
Sequence 4	Sildenafil	Period 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil
Sequence 1	Sildenafil	Period 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1
Sequence 2	SAR407899	Period 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2
Sequence 3	SAR407899	Period 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo
Sequence 3	Placebo	Period 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo
Sequence 4	SAR407899	Period 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil
Sequence 4	Placebo	Period 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil
Sequence 1	SAR407899	Period 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1
Sequence 3	Sildenafil	Period 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo

Primary Outcome Measures

Name	Time	Method
Duration of penile rigidity during sexual stimulation	4 hours following drug administration

Secondary Outcome Measures

Name	Time	Method
Blood pressure	12 hours following drug administration
Time to onset of penile rigidity	4 hours following drug administration

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇫🇷 Paris, France