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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00853606

Public ClinicalTrials.gov record NCT00853606. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 1:36 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00853606
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
VIVUS LLC
Industry
Enrollment
712 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2009 (Type not available)
Primary completion
Apr 2010 (Actual)
Completion
Apr 2010 (Actual)
Last update posted
Aug 17, 2012

2009 – 2010

United States locations

U.S. sites
40
U.S. states
16
U.S. cities
37
Facility City State ZIP Site status
Research Site Birmingham Alabama 35209 —
Research Site Homewood Alabama 35209 —
Research Site Tucson Arizona 85712 —
Research Site Sacramento California 95821 —
Research Site San Diego California 92120 —
Research Site San Diego California 92123 —
Research Site Waterbury Connecticut 06708 —
Research Site Clearwater Florida 33756 —
Research Site Clearwater Florida 33761 —
Research Site Coral Gables Florida 33134 —
Research Site Hialeah Florida 33012 —
Research Site Jacksonville Florida 32205 —
Research Site Jupiter Florida 33458 —
Research Site Ocala Florida 34471 —
Research Site Pembroke Pines Florida 33024 —
Research Site Ponte Vedra Florida 32081 —
Research Site Tampa Florida 33624 —
Research Site Sandy Springs Georgia 30328 —
Research Site Wichita Kansas 67205 —
Research Site Madisonville Kentucky 42431 —
Research Site Shreveport Louisiana 71106 —
Research Site Kansas City Missouri 64114 —
Research Site Lawrenceville New Jersey 08648 —
Research Site Albany New York 12206 —
Research Site New York New York 10016 —
Research Site Cary North Carolina 27518 —
Research Site Charlotte North Carolina 28207 —
Research Site Charlotte North Carolina 28209 —
Research Site Harrisburg North Carolina 28075 —
Research Site Hickory North Carolina 28601 —
Research Site Raleigh North Carolina 27609 —
Research Site Salisbury North Carolina 28144 —
Research Site Wilmington North Carolina 28401 —
Research Site Winston-Salem North Carolina 27103 —
Research Site Cleveland Ohio 44122 —
Research Site Bala-Cynwyd Pennsylvania 19004 —
Research Site Lancaster Pennsylvania 17601 —
Research Site El Paso Texas 79935 —
Research Site Houston Texas 77074 —
Research Site Spring Texas 77386 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00853606, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 17, 2012 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00853606 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →