Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy

Summary

The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing radical prostatectomy.

Timeline

Start

2009-04

Primary completion

2011-04

Completion

2011-04

Outcome

Met primary endpoint

paper with all 3 primary end points being achieved at both dose levels. PMID 23219537 ↗

paper After 12 weeks there were significantly greater increases in SEP2 and SEP3 and change in mean IIEF-EF domain score with 100 and 200 mg avanafil vs placebo (p <0.01). PMID 23219537 ↗

Publications

• Mulhall JP, Burnett AL, Wang R, McVary KT, Moul JW, Bowden CH, DiDonato K, Shih W, Day WW. A phase 3, placebo controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve sparing radical prostatectomy. J Urol. 2013 Jun;189(6):2229-36. doi: 10.1016/j.juro.2012.11.177. Epub 2012 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avanafil	Small molecule	100 mg	—
Subject	Avanafil	Small molecule	200 mg	—

Indications