A PHASE II DOUBLE-BLIND VEHICLE-CONTROLLED CROSSOVER SINGLE DOSE (400 µG) V0147 GEL EFFECT AND TOLERANCE STUDY IN SPINAL CORD INJURED PATIENTS WITH ERECTILE DYSFUNCTIO
- Conditions
- Erectile dysfunctionMedDRA version: 21.1 Level: PT Classification code 10052004 Term: Organic erectile dysfunction System Organ Class: 10038604 - Reproductive system and breast disorders
- Registration Number
- EUCTR2007-001058-16-FR
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
·Male,18-40 years of age,
Body mass index (BMI) between 18 and 32,
With erectile dysfunction (ED) resulting from spinal cord injury,
Spinal cord injury (SCI) at least 6 months before pre-selection visit,
With normal erectile function before SCI,
Mild to moderate ED with an Erectile Function domain score of the International Index of Erectile Function (IIEF) = 17 and = 21,
Patient accepting not to use any product in the same indication during the study period,
Patient accepting to participate to the study and to give a written informed consent,
Registered with a social security or health insurance system
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Criteria related to pathologies:
Clinically significant anatomical abnormalities such as phimosis,
La Peyronie’s disease, penile curvature, penile nodules or fibrosis, history of priapism,
Penile implant,
Chronic medical illness (hypertension, diabetes mellitus, renal or hepatic dysfunction, atherosclerosis, cardiovascular risk factors including hyperlipidemia),
Criteria related to treatments:
Intake of any drug inducing erectile response within the week preceding the pre-selection visit (PDE5 inhibitors, alprostadil, papaverine), or use of vacuum pumps,
Any androgen therapy,
Treatment with any medication that may cause erectile dysfunction,
Non-responders to intracavernous injections of PGE1 whatever the dose or to PDE5 inhibitors.
History of hypersensitivity (abnormal drug reaction or idiosyncrasy or asthma) to alprostadil or to at least one ingredient of the test product.
Criteria related to the population:
Patient whose partner is pregnant or may become pregnant during the study.
Patient who is in the 1-month exclusion period of a previous study or participating to another clinical trial during this study,
Patient who has a history of major medical/psychiatric illness or surgery which, in the judgment of the investigator, may interfere with study medication metabolism and/or study implementation and/or study parameter assessment,
Patient who has forfeited his freedom by administrative or legal award, or who is under guardianship, or who has been admitted to a sanitary or social institution, or who is in an emergency situation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method