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

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ClinicalTrials.gov Identifier: NCT00914277
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : May 2, 2011
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: SAR407899 Drug: Placebo Drug: Sildenafil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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).
Study Start Date : May 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Sildenafil

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Duration of penile rigidity during sexual stimulation [ Time Frame: 4 hours following drug administration ]

Secondary Outcome Measures :
  1. Time to onset of penile rigidity [ Time Frame: 4 hours following drug administration ]
  2. Blood pressure [ Time Frame: 12 hours following drug administration ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914277


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

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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
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011
Keywords provided by Sanofi:
Rho-kinase inhibitor
male impotence
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sildenafil Citrate
Genital Diseases, Male
Mental Disorders
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents