Clinical trialNCT00853606CompletedPhase 3Interventional

Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction

SponsorVIVUS LLCEnrollment712Erectile Dysfunction

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Andrew McCullough, MD
NYU Urology Associates
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

40 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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Birmingham, Alabama, United States
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Homewood, Alabama, United States
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Tucson, Arizona, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Waterbury, Connecticut, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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Ponte Vedra, Florida, United States
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Tampa, Florida, United States
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Sandy Springs, Georgia, United States
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Wichita, Kansas, United States
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Madisonville, Kentucky, United States
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Shreveport, Louisiana, United States
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Kansas City, Missouri, United States
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Lawrenceville, New Jersey, United States
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Albany, New York, United States
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New York, New York, United States
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Cary, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Harrisburg, North Carolina, United States
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Hickory, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Bala-Cynwyd, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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Spring, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Avanafil

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Mar 2009
Primary completion: 30 Apr 2010
Completion: 30 Apr 2010
Last update posted: 17 Aug 2012
Registered enrollment: 712
Registry id: NCT00853606

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.