drugset / Trial / NCT00903981

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

NCT00903981

Phase 3 Completed 208 enrolled JW Pharmaceutical
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-03
Primary completion
2009-10
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Avanafil Small molecule 100 mg Oral
Subject Avanafil Small molecule 200 mg Oral

Indications