This Study is to Evaluate the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction. — SPEED  

Erectile Dysfunction Clinical Trial

Official title: A Double-blind, Stratified Randomization, Placebo Controlled, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Avanafil in Subjects With Moderate to Severe Erectile Dysfunction in Korea.

Status Completed

Clinical Trial Summary

The objective of this study is to evaluate the safety and efficacy of Avanafil in the treatment of erectile dysfunction with moderate to severe in subjects. And, this is to additionally confirm the efficacy and safety after initiating treatment with Avanafil 100mg and later increasing to 200mg, compared with continuing treatment with Avanafile 100mg, in subjects.

Clinical Trial Description

All subjects, who are judged to be suitable to the clinical trial after 4-week free run-in period was completed, should be administered with Avanafil 100mg(study group) or placebo 100mg(control group) for the first 4 weeks after randomization. When there are no moderate to severe adverse events at the 4 weeks evaluation after administration, and when it is decided by the researcher that the effect of Avanafil or placebo 100mg against erectile dysfunction is insufficient, a dosage increase to 200mg is executed. For subjects with a sufficient improvement effect on ED at 100mg, no dosage increase is allowed, and the previous 100mg administration should be maintained until the termination of the study. ;

Related Conditions & MeSH terms

• Erectile Dysfunction

• NCT number: NCT01705197
• Study type: Interventional
• Source: JW Pharmaceutical
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Completion date: November 2013