Erectile dysfunction MedDRA version: 12.1 Level: LLT Classification code 10061461 Term: Erectile dysfunction
Conditions
Interventions
Trade Name: Levitra
Product Name: Vardenafil 20mg
Product Code: BAY 38-9456
Pharmaceutical Form: Tablet
INN or Proposed INN: VARDENAFIL
CAS Number: 224785-90-4
Current Sponsor code: BAY 38-9456
Concen
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Open-label run-in phase (first four weeks) •Written informed consent signed before any study-specific procedure •History of ED for at least 6 months prior to screening, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse"; the diagnosis of ED has to be confirmed by a physician •Stable, heterosexual relationship for at least 6 months prior to screening •Aged 18 to 64 years (inclusive) at the first screening examination •History of previous use of at least 1 marketed PDE5 inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose Double-blind treatment phase (last four weeks) •At least 4 attempts at sexual intercourse on 4 separate days during the open-label run-in phase with use of 20 mg vardenafil approximately 1 hour before attempting intercourse •IIEF EF score =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contraindication to use of vardenafil •History of prostatectomy due to prostate cancer, including nerve-sparing techniques. •Concomitant use of a-adrenergic blockers •History of spinal cord injury •Resting hypotension, i.e. SBP 170 mmHg or DBP >110 mmHg at rest •Symptomatic orthostatic hypotension with a decrease in SBP >20 mmHg or in DBP >10 mmHg subsequent to change from the supine to standing position
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the efficacy of a combination of BAY 60 4552 and vardenafil in men with ED and insufficient response to standard therapy with 20 mg vardenafil taken as needed (prn) during the 4 week open-label run in phase;Secondary Objective: •Safety and tolerability of the combination when given od for 4 weeks •Pharmacokinetics of vardenafil, its metabolite M-1 (BAY 44 5576), and BAY 60 4552 based on a 0 - 4-hour profile at Visit 4 and concentration values at approximately 12 hours post-administration at Visit 5 (interim visit) and Visit 7 (end-of-treatment visit) ;Primary end point(s): Primary endpoint is the severity of erectile dysfunction assessed by the IIEF-EF (International Index of Erectile Function – Erectile Function subscale) | — |
Countries
Finland, France, Germany, Italy, Netherlands, Spain, Sweden
Outcome results
None listed