Conditions: Benign Prostatic Hyperplasia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 260
Healthy volunteers: no

Brief summary:
The purpose of this study is:

* To assess safety of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia (BPH) and risk of progression.
* To assess efficacy of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia and risk of progression.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Afalaza intervention 2: Placebo
Intervention descriptions: intervention 1: Safety and Efficacy intervention 2: Safety and Efficacy

Protocol document: