Conditions: Prostatic Hyperplasia
Keywords: Combination Therapy dutasteride BPH
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4844
Healthy volunteers: no

Brief summary:
This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

Detailed description:
A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.

Arms:
arm 1: dutasteride 0.5mg once daily arm 2: Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily arm 3: tamsulosin 0.4mg once daily

Interventions: intervention 1: dutasteride 0.5mg once daily for 4 years intervention 2: tamsulosin 0.4mg once daily for 4 years
Intervention descriptions: intervention 1: combination or single agent intervention 2: combination agent or single agent

Protocol document: