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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Erectile Dysfunction

Treatments: Drug: Placebo; Drug: Sildenafil; Drug: SAR407899

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914277

EudraCT:2009-009936-56

ACT10775

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 4 patient groups

Sequence 1

Experimental group

Description:

Period 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1

Treatment:

Drug: SAR407899

Drug: Sildenafil

Drug: Placebo

Sequence 2

Experimental group

Description:

Period 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2

Treatment:

Drug: SAR407899

Drug: Sildenafil

Drug: Placebo

Sequence 3

Experimental group

Description:

Period 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo

Treatment:

Drug: SAR407899

Drug: Sildenafil

Drug: Placebo

Sequence 4

Experimental group

Description:

Period 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil

Treatment:

Drug: SAR407899

Drug: Sildenafil

Drug: Placebo