CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 712 enrolled
Drug / intervention
avanafildrug
Likely dose
avanafil 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00853606
NCT00853606Phase 3Completed
CompareCT.gov

An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction

VIVUS LLC·interventional·Posted Mar 2, 2009·Updated Aug 17, 2012

In Brief

A Phase 3 clinical trial evaluating avanafil for Erectile Dysfunction. Completed, enrolled 712 participants across 40 sites.

Detailed Summary

This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErectile Dysfunction
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2009
Enrollment StartMar 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.3 years ago

Interventions

avanafildrug

All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with 100 mg may undergo dose reduction to 50 mg. Subjects who tolerate avanafil 100 mg but who desire increased efficacy may request a dose increase to 200 mg.