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

NCT01705197 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2017-03-10

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Kim Se Woong, Doctor · Catholic hospital in Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-04-30
Completion
2013-11-30

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01705197 on ClinicalTrials.gov