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

Erectile Dysfunction Clinical Trial

— RHOKET  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914277
• Other study ID #: ACT10775
• Secondary ID: EudraCT:2009-009
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2009
• Last updated: April 29, 2011
• Start date: May 2009
• Est. completion date: October 2009

Study information

• Verified date: April 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• SAR407899
Oral administration
• Placebo
Oral administration
• Sildenafil
Oral administration

Locations

Country	Name	City	State
France	Sanofi-Aventis Administrative Office	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of penile rigidity during sexual stimulation		4 hours following drug administration	No
Secondary	Time to onset of penile rigidity		4 hours following drug administration	No
Secondary	Blood pressure		12 hours following drug administration	Yes