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

NCT00037141 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2007-10-10

No results posted yet for this study

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

DRUG

dehydrated alcohol

Sponsors & Collaborators

  • American Medical Systems

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Completion
2004-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00037141 on ClinicalTrials.gov