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 - ND

• Conditions: Erectile dysfunction; MedDRA version: 9.1Level: PTClassification code 10061461

• Registration Number: EUCTR2010-020122-18-IT
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 267

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified