SAR407899 Single-Dose in Treatment of Mild to Moderate Erectile Dysfunction - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00914277

Purpose

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.

Condition	Intervention	Phase
Erectile Dysfunction	Drug: SAR407899 Drug: Placebo Drug: Sildenafil	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
Official 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).

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Duration of penile rigidity during sexual stimulation [ Time Frame: 4 hours following drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to onset of penile rigidity [ Time Frame: 4 hours following drug administration ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: 12 hours following drug administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	May 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sequence 1: Experimental Period 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1	Drug: SAR407899 Oral administration Drug: Placebo Oral administration Drug: Sildenafil Oral administration
Sequence 2: Experimental Period 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2	Drug: SAR407899 Oral administration Drug: Placebo Oral administration Drug: Sildenafil Oral administration
Sequence 3: Experimental Period 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo	Drug: SAR407899 Oral administration Drug: Placebo Oral administration Drug: Sildenafil Oral administration
Sequence 4: Experimental Period 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil	Drug: SAR407899 Oral administration Drug: Placebo Oral administration Drug: Sildenafil Oral administration

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914277

Contacts

Contact: Public Registry ICD

GV-Contact-us@sanofi-aventis.com

Locations

France
Sanofi-aventis Administrative Office	Recruiting
Paris, France

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Lionel HOVSEPIAN, MD

SGS Aster Life Science Services - Paris-France

More Information

No publications provided

Responsible Party:	sanofi-aventis ( International Clinical Development Study Director )
Study ID Numbers:	ACT10775, EudraCT:2009-009936-56
Study First Received:	June 2, 2009
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00914277 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

Rho-kinase inhibitor
male impotence

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Vasodilator Agents
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Mental Disorders

Muscle Rigidity
Sildenafil
Cardiovascular Agents
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Sildenafil
Enzyme Inhibitors
Cardiovascular Agents
Genital Diseases, Male

Sexual and Gender Disorders
Pharmacologic Actions
Sexual Dysfunction, Physiological
Phosphodiesterase Inhibitors
Mental Disorders
Therapeutic Uses
Erectile Dysfunction

ClinicalTrials.gov processed this record on September 03, 2009