Conditions: Erectile Dysfunction
Keywords: ED Erectile Dysfunction Dysfunction Erectile
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 712
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: avanafil
Intervention descriptions: intervention 1: 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.

Protocol document: