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

Phase 1

• Conditions: Erectile dysfunction; MedDRA version: 12.1Level: LLTClassification code 10061461Term: Erectile dysfunction

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-08
• Study Completion: 2011-05-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 0

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 a-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

Primary Outcome Measures

Name	Time	Method
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<br>•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)<br>;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)