NCT00853606

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 712 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	avanafil	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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-03-02
• Last updated: 2012-08-17
• Results posted: 2012-06-28

Locations

40 sites across 1 country: United States