Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 217
Healthy volunteers: no

Brief summary:
The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: tadalafil intervention 2: placebo
Intervention descriptions: intervention 1: 5 milligrams (mg) administered orally once a day for 12 weeks intervention 2: tablet administered orally once a day for 12 weeks.

Protocol document: