Conditions: Erectile Dysfunction Benign Prostatic Hyperplasia
Keywords: Erectile Dysfunction Benign Prostatic Hyperplasia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 606
Healthy volunteers: no

Brief summary:
Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: tablet once daily by mouth for 12 weeks. intervention 2: Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.

Protocol document: