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

NCT ID: NCT00914277

Last Updated: 2011-05-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-10-31

Brief Summary

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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

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Group Type EXPERIMENTAL

SAR407899

Intervention Type DRUG

Oral administration

Placebo

Intervention Type DRUG

Oral administration

Sildenafil

Intervention Type DRUG

Oral administration

Sequence 2

Period 1: sildenafil

Period 2: SAR407899 dose level 1

Period 3: placebo

Period 4: SAR407899 dose level 2

Group Type EXPERIMENTAL

SAR407899

Intervention Type DRUG

Oral administration

Placebo

Intervention Type DRUG

Oral administration

Sildenafil

Intervention Type DRUG

Oral administration

Sequence 3

Period 1: SAR407899 dose level 1

Period 2: SAR407899 dose level 2

Period 3: sildenafil

Period 4: placebo

Group Type EXPERIMENTAL

SAR407899

Intervention Type DRUG

Oral administration

Placebo

Intervention Type DRUG

Oral administration

Sildenafil

Intervention Type DRUG

Oral administration

Sequence 4

Period 1: SAR407899 dose level 2

Period 2: placebo

Period 3: SAR407899 dose level 1

Period 4: sildenafil

Group Type EXPERIMENTAL

SAR407899

Intervention Type DRUG

Oral administration

Placebo

Intervention Type DRUG

Oral administration

Sildenafil

Intervention Type DRUG

Oral administration

Interventions

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SAR407899

Oral administration

Intervention Type DRUG

Placebo

Oral administration

Intervention Type DRUG

Sildenafil

Oral administration

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

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

Site Status

Countries

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France

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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