Conditions: Erectile Dysfunction Metabolic Syndrome
Keywords: Vardenafil Erectile Dysfunction Double-blind study
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: no

Brief summary:
This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)

Detailed description:

Arms:
arm 1: Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks arm 2: Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks

Interventions: intervention 1: Vardenafil (Levitra, BAY38-9456) intervention 2: Placebo
Intervention descriptions: intervention 1: Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks intervention 2: Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks

Protocol document: