NCT00037141

Safety/Tolerability Study of Alcohol Injection for Treatment of BPH (Enlarged Prostate)

Evaluation of the Safety and Tolerability of Transurethral Alcohol Injection for the Treatment of BPH (Enlarged Prostate)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (planned)
• Sponsor: American Medical Systems · Industry
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, prospective randomized dosing and safety research study. A maximum of 150 men will be enrolled in the study. Qualifying patients will receive one of three possible doses of the study drug. Symptoms will be evaluated before treatment, and then 1-week, 1-month, 3-months, and 6-months following treatment.

Conditions

• Prostate Disease
• BPH
• Benign Prostatic Hyperplasia
• Benign Prostatic Hypertrophy

Interventions

Type	Name	Description
DRUG	dehydrated alcohol

Timeline

• Start date: 2002-03-01
• Completion: 2004-03-01
• First posted: 2002-05-17
• Last updated: 2007-10-10