NCT00037141

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2002

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2002

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

October 10, 2007

Status Verified

June 1, 2004

First QC Date

May 15, 2002

Last Update Submit

October 4, 2007

Conditions

Prostate DiseaseBPHBenign Prostatic HyperplasiaBenign Prostatic Hypertrophy

Keywords

ProstateBPHProstatitis

Interventions

dehydrated alcoholDRUG

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic DiseasesProstatic HyperplasiaProstatitis

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2002

First Posted

May 17, 2002

Study Start

March 1, 2002

Study Completion

March 1, 2004

Last Updated

October 10, 2007

Record last verified: 2004-06