Conditions: Benign Prostate Hyperplasia Erectile Dysfunction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 909
Healthy volunteers: no

Brief summary:
The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract Symptoms (BPH-LUTS) and improve their quality of life.

Detailed description:

Arms:
arm 1: Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks. arm 2: Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.

Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period arm 3: Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.

Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period

Interventions: intervention 1: 5 mg Tadalafil intervention 2: Placebo intervention 3: 0.2 mg Tamsulosin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol document: