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

PHASE3CompletedINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

November 30, 2013

Conditions
Erectile Dysfunction
Interventions
DRUG

Avanafil 100 or 200mg

This study is designed as a double-blind, stratified randomized, placebo controlled, parallel group, multicenter, dose escalation study. For subjects with moderate to severe ED who have voluntarily signed the consent form, conduct screening and undertake the 4 weeks Free run-in period. For those who satisfy the study criteria during the review of subject's diaries composed during the free run-in period and the evaluation of inclusion/exclusion criteria at a future visit, drugs for each group are provided after randomized to Avanafil 100mg or placebo 100mg at a ratio of 2:1. At this time, subjects are random stratified to each group depending on their diabetes status.

Trial Locations (1)

Unknown

Catholic Univ. Seoul St. Mary's Hospital, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

JW Pharmaceutical

INDUSTRY