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

Sanofi24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Erectile Dysfunction

Interventions

SAR407899DRUG

Oral administration

PlaceboDRUG

Oral administration

SildenafilDRUG

Oral administration

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis Administrative Office

Paris, France

Outcomes

Primary Outcomes

Duration of penile rigidity during sexual stimulation

Time frame: 4 hours following drug administration

Secondary Outcomes

Time to onset of penile rigidity

Time frame: 4 hours following drug administration

Blood pressure

Time frame: 12 hours following drug administration

Data from ClinicalTrials.gov

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