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

April 29, 2011 updated by: Sanofi

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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: Placebo
Oral administration
Drug: SAR407899
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: Placebo
Oral administration
Drug: SAR407899
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: Placebo
Oral administration
Drug: SAR407899
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: Placebo
Oral administration
Drug: SAR407899
Oral administration
Drug: Sildenafil
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of penile rigidity during sexual stimulation
Time Frame: 4 hours following drug administration
4 hours following drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to onset of penile rigidity
Time Frame: 4 hours following drug administration
4 hours following drug administration
Blood pressure
Time Frame: 12 hours following drug administration
12 hours following drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (ESTIMATE)

June 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 2, 2011

Last Update Submitted That Met QC Criteria

April 29, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT10775
  • EudraCT:2009-009936-56

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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