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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00730418
First received: August 7, 2008
Last updated: August 25, 2010
Last verified: August 2010
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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:


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, Adverse events [ Time Frame: before treatment and 3mos, 12mos, and 24mos after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: doxazosin 4mg
doxazosin 4mg group
Drug: Doxazosin
Treatment with doxazosin 4mg daily for 24 mos
Other Name: Cadura XL 4mg
Experimental: doxazosin 8mg
doxazosin 8mg group
Drug: Doxazosin
Treatment with doxazosin 8mg daily for 24 mos
Other Name: Cadura XL 8mg

Detailed Description:

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
  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Samsung Medical Center
SEoul, Korea, Republic of, 135-710
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: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00730418     History of Changes
Other Study ID Numbers: 2006-08-118
Study First Received: August 7, 2008
Last Updated: August 25, 2010
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:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Adrenergic Agents
Doxazosin
Adrenergic alpha-Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic Antagonists
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Antagonists

ClinicalTrials.gov processed this record on July 23, 2014