Conditions: Benign Prostatic Hyperplasia (BPH)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 511
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)

Detailed description:

Arms:
arm 1: Placebo tablet with tamsulosin dose orally (po) once daily (QD) and placebo capsule with tadalafil dose po QD for 12 weeks arm 2: Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks arm 3: Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks

Interventions: intervention 1: Tadalafil 5 mg intervention 2: Placebo tablet intervention 3: Tamsulosin intervention 4: Placebo capsule
Intervention descriptions: intervention 1: Tadalafil 5 mg po QD for 12 weeks intervention 2: Placebo tablet po QD for 12 weeks intervention 3: Tamsulosin 0.4 mg po QD for 12 weeks intervention 4: Placebo capsule po QD for 12 weeks

Protocol document: