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

Tracking Information
First Received Date ^ICMJE	May 15, 2002
Last Updated Date	October 4, 2007
Start Date ^ICMJE	March 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00037141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety/Tolerability Study of Alcohol Injection for Treatment of BPH (Enlarged Prostate)
Official Title ^ICMJE	Evaluation of the Safety and Tolerability of Transurethral Alcohol Injection for the Treatment of BPH (Enlarged Prostate)
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
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Historical Control, Parallel Assignment
Condition ^ICMJE	Prostate Disease BPH Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy
Intervention ^ICMJE	Drug: dehydrated alcohol
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	150
Completion Date	March 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	50 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00037141
Responsible Party
Study ID Numbers ^ICMJE	AMS002
Study Sponsor ^ICMJE	American Medical Systems
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	American Medical Systems
Verification Date	June 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP