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Completed

NCT Number: NCT00914277

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

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR407899

Drug

Oral administration

Placebo

Drug

Oral administration

Sildenafil

Drug

Oral administration

Primary outcomes

  1. Duration of penile rigidity during sexual stimulation

    Time frame: 4 hours following drug administration

Secondary outcomes

  1. Time to onset of penile rigidity

    Time frame: 4 hours following drug administration

  2. Blood pressure

    Time frame: 12 hours following drug administration

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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).

Acronym: RHOKET

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 4, 2009
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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