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

This study has been completed.

First Received: May 15, 2002 Last Updated: October 4, 2007 History of Changes

Sponsor:	American Medical Systems
Information provided by:	American Medical Systems
ClinicalTrials.gov Identifier:	NCT00037141

Purpose

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.

Condition	Intervention	Phase
Prostate Disease BPH Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy	Drug: dehydrated alcohol	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Historical Control, Parallel Assignment
Official Title:	Evaluation of the Safety and Tolerability of Transurethral Alcohol Injection for the Treatment of BPH (Enlarged Prostate)

Resource links provided by NLM:

MedlinePlus related topics: Prostate Diseases

Drug Information available for: Ethanol

U.S. FDA Resources

Further study details as provided by American Medical Systems:

Estimated Enrollment:	150
Study Start Date:	March 2002
Estimated Study Completion Date:	March 2004

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Eligible patients are 50 to 80-year-old men who have experienced some or all of the following urinary symptoms for at least 6 months:

frequent or urgent need to urinate
difficulty starting their urinary stream
interruption of their urinary stream
feeling of incomplete emptying of bladder after urinating
interruption of sleep due to the urge to urinate

Patients should have tried oral medication for their condition in the past, and be willing to discontinue any current BPH medications for a period of time before undergoing study treatment. They should be in good general health and have no previous surgery, or other procedure(s) intended to reduce prostate size.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	AMS002
Study First Received:	May 15, 2002
Last Updated:	October 4, 2007
ClinicalTrials.gov Identifier:	NCT00037141 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by American Medical Systems:

Prostate
BPH
Prostatitis

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Anti-Infective Agents
Prostatic Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Genital Diseases, Male
Pharmacologic Actions
Anti-Infective Agents, Local

Hyperplasia
Hypertrophy
Pathologic Processes
Prostatic Hyperplasia
Therapeutic Uses
Central Nervous System Agents
Ethanol

ClinicalTrials.gov processed this record on November 22, 2009