Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia
Information source: Samsung Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: Doxazosin (Drug); Doxazosin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Samsung Medical Center Official(s) and/or principal investigator(s):
Kru-Sung Lee, Ph.D., M.D., Principal Investigator, Affiliation: Samsung Medical Center
Overall contact:
Kyu-Sung Lee, Ph.D., M.D., Phone: +82-2-3410-3554, Email: ksleedr@skku.edu
Summary
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)
Clinical Details
Official title: A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-Adrenergic Receptors in Men With Benign Prostatic Hyperplasia
Study design: Basic Science, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Expression of alpha-1 adrenoceptor
Secondary outcome: International Prostate Symptom Score,
Patient perception of bladder condition,
Maximal flow rate of urine,
Postvoid Residual,
Prostate volume,
Serum PSA level,
Advers events
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
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Kyu-Sung Lee, Ph.D., M.D., Phone: +82-2-3410-3554, Email: ksleedr@skku.edu
Samsung Medical Center, SEoul 135-710, Korea, Republic of; Recruiting
Kyu-Sung Lee, Ph.D., M.D., Phone: +82-2-3410-3554, Email: ksleedr@skku.edu
Deok Hyun Han, M.D., Phone: +82-2-3410-3559, Email: deokhyun.han@samsung.com
Kyu-Sung Lee, Ph.D., M.D., Principal Investigator
Deok Hyun Han, M.D., Sub-Investigator
Young-Suk Lee, M.D., Sub-Investigator
Additional Information
Starting date: January 2007
Ending date: December 2009
Last updated: August 7, 2008
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