Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

Compare once daily vs on demand treatment in men with erectile dysfunction.

Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out:

A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Vardenafil Dihydrochloride

Criteria

Inclusion Criteria:

• Males 18-64 years of age

• Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)

• History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease

• Stable, heterosexual relationship for more than six months

Exclusion Criteria:

• Primary hypoactive sexual desire

• History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month

• Nitrate therapy.