A prospective, randomized, double-blind, double-dummy, placebo- and active controlled, multicenter study assessing the efficacy and safety of the combination BAY 60 4552 / vardenafil compared to vardenafil (20 mg) for the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors

Bayer HealthCare AG0 sites267 target enrollmentAugust 31, 2010

Overview

No summary available.

Registry

who.int

Start Date

August 31, 2010

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•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 \<17
•At least 50% of attempts at sexual intercourse during the open\-label run\-in phase were unsuccessful

•Contraindication to use of vardenafil
•History of prostatectomy due to prostate cancer, including nerve\-sparing techniques.
•Concomitant use of adrenergic blockers
•History of spinal cord injury
•Resting hypotension, i.e. SBP \<100 mmHg at rest
•Moderate / severe hypertension, 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
•History of pelvic radiotherapy
•Pulmonary venous occlusive disease