NCT00903981

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

A Randomized, Placebo Controlled, Double Blind, Multicenter Therapeutic Confirmatory Clinical Study for the Evaluation of the Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm the efficacy and the safety of Avanafil 100mg, 200mg or placebo administered orally for 12 weeks in patients with erectile dysfunction. The efficacy is evaluated by IIEF, SEP Q2 and Q3 and GEAQ and the safety is evaluated by laboratory tests, vital signs, physical examination and adverse events.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Avanafil	2 tablets(Avanafil 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse
DRUG	Avanafil	2 Tablets(Avanafil 200mg tablet + Placebo 100mg tablet), 30 minutes before sexual intercourse
DRUG	Placebo	2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-10-01
• Completion: 2009-11-01
• First posted: 2009-05-19
• Last updated: 2010-04-23

Locations

1 site across 1 country: South Korea