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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00914277
First received: June 2, 2009
Last updated: April 29, 2011
Last verified: April 2011
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Sanofi:

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 ]

Enrollment: 24
Study Start Date: May 2009
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1

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
Experimental: Sequence 2

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
Experimental: Sequence 3

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
Experimental: Sequence 4

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

Locations
France
Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Lionel HOVSEPIAN, MD SGS Aster Life Science Services - Paris-France
  More Information

No publications provided

Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00914277     History of Changes
Other Study ID Numbers: ACT10775, EudraCT:2009-009936-56
Study First Received: June 2, 2009
Last Updated: April 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Rho-kinase inhibitor
male impotence

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013