Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia
A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-adrenergic Receptors in Men With Benign Prostatic Hyperplasia
1 other identifier
interventional
25
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
1 active site
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
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 7, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedAugust 26, 2010
August 1, 2010
3.2 years
August 7, 2008
August 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Expression of alpha-1 adrenoceptor
before treatment and 12mos and 24 mos after treatment
Secondary Outcomes (1)
International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Adverse events
before treatment and 3mos, 12mos, and 24mos after treatment
Study Arms (2)
doxazosin 4mg
EXPERIMENTALdoxazosin 4mg group
doxazosin 8mg
EXPERIMENTALdoxazosin 8mg group
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kru-Sung Lee, Ph.D., M.D.
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 7, 2008
First Posted
August 8, 2008
Study Start
January 1, 2007
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
August 26, 2010
Record last verified: 2010-08