BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: GlaxoSmithKline
• Treatments: Vardenafil Dihydrochloride

Criteria

Inclusion Criteria:

• Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).

• At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.

Exclusion Criteria:

• Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance.

• Primary hypoactive sexual desire.-Spinal cord injury-History of surgical prostatectomy (transurethral interventions not excluded).

• Unstable angina pectoris.

• History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.

• Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate >100 BPM).