A randomized, placebo controlled double-blind, 12-week treatment trial in men with moderate to severe symptoms of benign prostatic hyperplasia. The trail is about to examine the effect of Brizo® on reduction of BPH related symptoms.

1. Males in good general health 50 years of age and older, with symptoms of moderate to severe benign prostatic hyperplasia.

2. 120 patients: Study arm- min. 80 patients Placebo arm- min. 40 patients Final Aim for Stat. Sig.: 75% of recruitment group (90 patients)

3. Duration - 12 weeks with 3 visits: 0,6,12 weeks

4. The following procedures are utilized:

   • Physical exams - visit 1,3.
   • Drugs/food supplement usage questionnaire - visit 1.
   • Product supply Control - visit 1,2.3
   • Clinical laboratory tests : psa, cbc, bun - visit 1,3.
   • Uroflowmetry test visit - visit 1,3.
   • IPSS- International Prostate Symptom Score - questionnaire - visit 1, 3.
   • IIEF questionnaire - visit 1, 3.

5. dosage: 1 capsule twice daily (morning & evening) can be taken with or without food

Inclusion Criteria:

Males in good general health at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia

Exclusion Criteria:

• Inability to complete the questionnaire.
• Patients with or suspected of having prostate cancer.
• Patients who have undergone a surgical procedure in the past year and / or who have taken medications or supplements in the past six months to treat BPH.
• Patients treated with drugs for kidney / urinary tract problems.
• Allergy to soy.