Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)

Phase 3 Completed 390 enrolled VIVUS LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is being conducted to compare the safety and efficacy of 2 doses of avanafil to placebo in diabetic men with mild to severe erectile dysfunction.

Timeline

Start: 2008-12
Primary completion: 2010-02
Completion: 2010-02

Outcome

Met primary endpoint

paper were significantly improved with both avanafil, 100 mg (P≤.002), and avanafil, 200 mg (P<.001). PMID 22857780 ↗

Publications

Goldstein I, Jones LA, Belkoff LH, Karlin GS, Bowden CH, Peterson CA, Trask BA, Day WW. Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus. Mayo Clin Proc. 2012 Sep;87(9):843-52. doi: 10.1016/j.mayocp.2012.06.016. Epub 2012 Aug 1.

Drugs

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