Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia

NCT ID: NCT00730418

Last Updated: 2010-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study, we investigate the changes of the expression of alpha adrenergic receptor in the prostate tissue during 2-yr medication period in the man with benign prostatic hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin (4mg, 8mg)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To compare the expression of alpha-1 adrenergic receptors, we will use various methodologies such as

* Real-time RT-PCR
* Radioligand receptor binding
* Western blot
* Immunohistochemistry

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Prostatic Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

doxazosin 4mg

doxazosin 4mg group

Group Type EXPERIMENTAL

Doxazosin

Intervention Type DRUG

Treatment with doxazosin 4mg daily for 24 mos

doxazosin 8mg

doxazosin 8mg group

Group Type EXPERIMENTAL

Doxazosin

Intervention Type DRUG

Treatment with doxazosin 8mg daily for 24 mos

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxazosin

Treatment with doxazosin 4mg daily for 24 mos

Intervention Type DRUG

Doxazosin

Treatment with doxazosin 8mg daily for 24 mos

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cadura XL 4mg Cadura XL 8mg

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 50 yrs or greater
* International prostatic symptom score \>= 8
* Maximal flow rate \< 15mL/sec
* baseline PSA 2.5-10 ng/mL
* Pathologically proven BPH
* No medication history for BPH
* Able to give fully informed consent

Exclusion Criteria

* Previous use of alpha-blocker, 5-alpha reductase inhibitor
* Previous surgery for BPH
* Urologic cancer history
* Urethral stricture
* baseline PSA \> 10ng/mL
* BP \< 90/70 mmHg
* Orthotopic hypotension with syncope
* Serum Cr \> 2.0 mg/dl, alanine aminotransferase \> 1.5 times of normal limit
* Bacterial prostatitis within 1 year
* Urinary tract infection(UTI) more than 2 times within 1 year
* Active UTI or prostate biopsy within 1 month
* Unable to void
* Ped use because of incontinence
* Hypersensitivity to alpha-blocker that include quinazoline
* Unstable angina, Myocardial infarction, or cerebrovascular accident within 6 months
* Neurogenic bladder dysfunction (ex. multiple sclerosis, Parkinson's disease, Spinal injury etc.)
* Psychiatric problem
* Alcohol abuse or other drug abuse history
* Severe comorbidities unable to perform long-term trial
* seems not to be appropriate to this study because of any other reasons
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Samsung Medical Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kru-Sung Lee, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2006-08-118

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study in Benign Prostatic Hyperplasia
NCT01152190 COMPLETED PHASE3