Erectile dysfunction MedDRA version: 21.1 Level: PT Classification code 10052004 Term: Organic erectile dysfunction System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: alprostadil
Product Code: V0147GL
Pharmaceutical Form: Gel
INN or Proposed INN: alprostadil
Current Sponsor code: V0147GL
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ·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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to assess the ability of a single dose of 400 µg V0147 gel versus vehicle applied locally to induce an erectile response in spinal cord injured patients with erectile dysfunction.;Secondary Objective: The secondary objective is to assess the local and general tolerability of V0147 gel.; Primary end point(s): - Penile response evaluated with an Erection Assessment 5 point scale: 1 = no response (flaccidity),· 2 = some enlargement (not likely to be sufficient for penetration)· 3 = full enlargement (but insufficient rigidity),· 4 = erection sufficient for vaginal penetration but not fully rigid· 5 = full rigidity The response will be evaluated by the investigator.The evaluation will be made immediately before the administration of each dose topical formulation and 15, 30, 45 and 60 minutes thereafter.Before the application of the product the penile response score must be at 1 (score = 1 as flaccidity) on the Erection Assessment Scale. - Percentage of patient with an improvement of at least 3 points as compared to the baseline (score = 1 as flaccidity) on the Erection Assessment Scale - Latency and duration of the response: mean time to onset of response (min) mean time to maximal response (min) mean time to return to non-erect state (min) | — |
Countries
France
Outcome results
None listed