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

Completed · Phase 3

Conditions studied: Erectile Dysfunction

In brief

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.

Key facts

Study ID

NCT00853606

Run by

VIVUS LLC

People needed

712

Starts

2009-03-01

Expected to finish

2010-04-01

Last updated by the study team

2012-08-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Successfully completed the entire treatment period in a qualifying study (TA-301 [NCT00790751] or TA-302 [NCT00809471]);
• Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
• Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial;
• Agree to make at least 4 attempts at intercourse each month through the course of this study;
• Agree not to use any other treatments for erectile dysfunction during participation in this study.
• Provide written informed consent;
• Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314;
• Subjects requiring treatment with an excluded medication.

Where it is running

• Research Site — Wichita, Kansas, United States
• Research Site — Madisonville, Kentucky, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — Lawrenceville, New Jersey, United States
• Research Site — Albany, New York, United States
• Research Site — New York, New York, United States
• Research Site — Cary, North Carolina, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Harrisburg, North Carolina, United States
• Research Site — Hickory, North Carolina, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Salisbury, North Carolina, United States
• Research Site — Wilmington, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Bala-Cynwyd, Pennsylvania, United States
• Research Site — Lancaster, Pennsylvania, United States
• Research Site — El Paso, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Spring, Texas, United States
• Research Site — Birmingham, Alabama, United States
• Research Site — Homewood, Alabama, United States
• Research Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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