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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00914277
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Duration (Months): 5
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Duration of penile rigidity during sexual stimulation [4 hours following drug administration]

Secondary Outcome Measures

1. Time to onset of penile rigidity [4 hours following drug administration]

2. Blood pressure [12 hours following drug administration]

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Paris		France

Sponsors and Collaborators

• Sanofi

Investigators

• Principal Investigator: Lionel HOVSEPIAN, MD, SGS Aster Life Science Services - Paris-France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00914277
• Other Study ID Numbers: ACT10775; EudraCT:2009-009936-56
• First Posted: Jun 4, 2009
• Last Update Posted: May 2, 2011
• Last Verified: Apr 1, 2011

• Keywords provided by , ,: Rho-kinase inhibitor; male impotence
• Additional relevant MeSH terms: Erectile Dysfunction; Sildenafil Citrate

Study Results

No Results Posted as of May 2, 2011