Benign Prostatic HyperplasiaNCT00730418
Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia
A study testing Doxazosin in people with Benign Prostatic Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
Trial 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) Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Doxazosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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)
Read the 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
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Doxazosin
- Keywords
- Benign Prostatic Hyperplasia, alpha Adrenergic Blockers, alpha-1 Adrenergic Receptor
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxazosinDrug
Also called Cadura XL 4mg
Treatment with doxazosin 4mg daily for 24 mos
DoxazosinDrug
Also called Cadura XL 8mg
Treatment with doxazosin 8mg daily for 24 mos
| Study group | Role | What they receive |
|---|---|---|
| doxazosin 4mg | Experimental | doxazosin 4mg group Receives: Drug: Doxazosin |
| doxazosin 8mg | Experimental | doxazosin 8mg group Receives: Drug: Doxazosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of alpha-1 adrenoceptor
Measured: 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
Measured: before treatment and 3mos, 12mos, and 24mos after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJan 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kru-Sung Lee, Ph.D., M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730418
- Sponsor's protocol ID
- 2006-08-118
- Status last verified
- Aug 2010
- First submitted
- 7 Aug 2008
- Last updated
- 26 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-adrenergic Receptors in Men With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00730418
- Acronym / sponsor ID
- 2006-08-118
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia, alpha Adrenergic Blockers, alpha-1 Adrenergic Receptor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxazosin 4mg | Experimental | Drug: Doxazosindoxazosin 4mg group |
| doxazosin 8mg | Experimental | Drug: Doxazosindoxazosin 8mg group |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 50 yrs or greater
- International prostatic symptom score >= 8
- Maximal flow rate < 15mL/sec
- baseline PSA 2.5-10 ng/mL
- Pathologically proven BPH
Key exclusion criteria (20 listed)
- Previous use of alpha-blocker, 5-alpha reductase inhibitor
- Previous surgery for BPH
- Urologic cancer history
- Urethral stricture
- baseline PSA > 10ng/mL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxazosinAlso: Cadura XL 4mgTreatment with doxazosin 4mg daily for 24 mos | Drug | doxazosin 4mg |
| DoxazosinAlso: Cadura XL 8mgTreatment with doxazosin 8mg daily for 24 mos | Drug | doxazosin 8mg |
Primary outcome
Expression of alpha-1 adrenoceptor
Time frame: before treatment and 12mos and 24 mos after treatment
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kru-Sung Lee, Ph.D., M.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxazosin in people with Benign Prostatic Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of alpha-1 adrenoceptor (time frame: before treatment and 12mos and 24 mos after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2010.