Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction

Phase 2 Completed 159 enrolled Pusan National University Hospital

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of Avanafil 50mg, 100mg, 200mg or placebo administered orally in patients with erectile dysfunction. In conclusions, Patients with erectile dysfunction (ED) were administered placebo, Avanafil 50mg, 100mg or 200mg 30 minutes before sexual intercourse for 8 weeks.

Timeline

Start: 2008-02
Primary completion: 2008-09
Completion: 2008-09

Outcome

Met primary endpoint

paper After 8 weeks of treatment, the dose groups except avanafil 50 mg scored significantly higher on the IIEF-EF domain from baseline than the placebo group. PMID 28480661 ↗

Publications

Park HJ, Kim SW, Kim JJ, Lee SW, Paick JS, Ahn TY, Park K, Park JK, Park NC. A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Therapeutic Confirmatory Study to Evaluate the Safety and Efficacy of Avanafil in Korean Patients with Erectile Dysfunction. J Korean Med Sci. 2017 Jun;32(6):1016-1023. doi: 10.3346/jkms.2017.32.6.1016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avanafil	Small molecule	50 mg	Oral
Subject	Avanafil	Small molecule	100 mg	Oral
Subject	Avanafil	Small molecule	200 mg	Oral