Conditions: Benign Prostatic Hyperplasia Enlarged Prostate
Keywords: Benign Prostatic Hyperplasia (BPH) Enlarged Prostate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 696
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Tadalafil intervention 2: Placebo intervention 3: Finasteride
Intervention descriptions: intervention 1: 5 milligrams (mg) administered orally, once daily for 26 weeks intervention 2: Administered orally, once daily for 26 weeks intervention 3: 5mg administered orally, once daily for 26 weeks

Protocol document: