Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia - Full Text View

Sponsor:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00730418

Purpose

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)

Condition	Intervention
Benign Prostatic Hyperplasia	Drug: Doxazosin

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-adrenergic Receptors in Men With Benign Prostatic Hyperplasia

Resource links provided by NLM:

Drug Information available for: Doxazosin Doxazosin mesylate

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

Expression of alpha-1 adrenoceptor [ Time Frame: before treatment and 12mos and 24 mos after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Advers events [ Time Frame: before treatment and 3mos, 12mos, and 24mos after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
doxazosin 4mg: Experimental doxazosin 4mg group	Drug: Doxazosin Treatment with doxazosin 4mg daily for 24 mos
doxazosin 8mg: Experimental doxazosin 8mg group	Drug: Doxazosin Treatment with doxazosin 8mg daily for 24 mos

Detailed Description:

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

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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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
Baterial 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 cormorbidities unable to perform long-term trial
seems not to be appropriate to this study because of any other reasons

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730418

Contacts

Contact: Kyu-Sung Lee, Ph.D., M.D.	+82-2-3410-3554	ksleedr@skku.edu
Contact: Deok Hyun Han, M.D.	+82-2-3410-3559	deokhyun.han@samsung.com

Locations

Korea, Republic of
Samsung Medical Center	Recruiting
SEoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee, Ph.D., M.D. +82-2-3410-3554 ksleedr@skku.edu
Contact: Deok Hyun Han, M.D. +82-2-3410-3559 deokhyun.han@samsung.com
Principal Investigator: Kyu-Sung Lee, Ph.D., M.D.
Sub-Investigator: Deok Hyun Han, M.D.
Sub-Investigator: Young-Suk Lee, M.D.

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:

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

Samsung Medical Center

More Information

No publications provided

Responsible Party:	Samsung Medical Center ( Kyu-Sung Lee/Professor )
Study ID Numbers:	2006-08-118
Study First Received:	August 7, 2008
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00730418 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:

Benign Prostatic Hyperplasia
alpha Adrenergic Blockers
alpha-1 Adrenergic Receptor

Additional relevant MeSH terms:

Neurotransmitter Agents
Prostatic Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents

Genital Diseases, Male
Pharmacologic Actions
Doxazosin
Hyperplasia
Pathologic Processes
Prostatic Hyperplasia
Therapeutic Uses
Adrenergic Antagonists

ClinicalTrials.gov processed this record on November 22, 2009