Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

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)

Timeline

Start

2008-11

Primary completion

2009-10

Completion

2009-10

Outcome

Met primary endpoint

paper Vardenafil was statistically significantly superior to placebo for all primary efficacy measures (P < 0.0001) PMID 21771281 ↗

Publications

• Results Schneider T, Gleissner J, Merfort F, Hermanns M, Beneke M, Ulbrich E. Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. J Sex Med. 2011 Oct;8(10):2904-11. doi: 10.1111/j.1743-6109.2011.02383.x. Epub 2011 Jul 19.

Drugs

Indications