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

Phase 1

Completed

• Conditions: Prostate Disease; BPH; Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy

• Registration Number: NCT00037141
• Lead Sponsor: American Medical Systems

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2002-05-15
• Study First Submitted QC: 2002-05-16
• Study First Posted: 2002-05-17
• Study Completion: 2004-03
• Status Verified: 2004-06
• Last Update Submitted: 2007-10-04
• Last Update Posted: 2007-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL