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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VIVUS, Inc.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.