Benign Prostatic HyperplasiaPhase 4NCT01301599
Comparison Between Alpha Blocker Monotherapy and 5ARI Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia (BPH)
A Phase 4 study testing combination therapy, alpha blocker monotherapy and 5 alpha reductase inhibitor monotherapy in people with Benign Prostatic Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is designed to investigate the comparison between alpha blocker monotherapy and 5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- combination therapy, alpha blocker monotherapy and 5 alpha reductase inhibitor monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Dec 2013
- Phase
- Phase 4
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male aged 45 years old and above (with no upper limit of age)
- patients who underwent combination therapy of alpha blocker and 5 ARI for more than 9 months
- IPSS ≤ 12
- Ability and willingness to correctly complete the micturition diary and questionnaire
- Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
Who cannot join
- An anticholinergic or antidiuretic if started less than 3 months prior to screening
- Patients who had surgical treatment due to LUTS
- Patients with suspected neurogenic bladder disorder
- Patients with cancer of any type including cancer of the prostate or bladder
- Patients with urethral stricture or bladder neck contracture
- Patients with suspicious chronic prostatitis/chronic pelvic pain syndrome
Show all 10Show fewer
- Acute bacterial prostatitis less than 6 months prior to screening
- Symptomatic acute urinary tract infection (UTI) less than 1 months prior to screening
- Patients who had underwent prostatic biopsy less than one month prior to screening
- Patients who had unstable angina or cerebral vascular disease less than 6 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Alpha Blocker Monotherapy and 5-alpha-reductase Inhibitor Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia
This study is designed to investigate the comparison between alpha blocker monotherapy and 5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic hyperplasia.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- combination therapy, alpha blocker monotherapy, 5 alpha reductase inhibitor monotherapy
- Keywords
- Benign Prostatic Hyperplasia, alpha blocker, 5-alpha reductase inhibitor, combination therapy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination therapyDrug
alpha blocker and 5-alpha-reductase inhibitor medication
alpha blocker monotherapyDrug
alpha blocker monotherapy group
5 alpha reductase inhibitor monotherapyDrug
5 alpha reductase inhibitor monotherapy
| Study group | Role | What they receive |
|---|---|---|
| combination group | Experimental | combination therapy of alpha blocker and 5-alpha-reductase inhibitor medication Receives: Drug: combination therapy |
| alpha blocker group | Active comparator | alpha blocker monotherapy Receives: Drug: alpha blocker monotherapy |
| 5 ARI group | Active comparator | 5 alpha-reductase inhibitor group Receives: Drug: 5 alpha reductase inhibitor monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric change of IPS and Numeric change of IPSS total score
Measured: from baseline to 12 months of treatment
Secondary outcomes (5)
Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS
Measured: from baseline to 12 months of treatment
Changes in urodynamic parameters : maximal flow rate and PVR
Measured: from baseline to 12 months of treatment
change in finding of TRUS
Measured: from baseline to 12 months of treatment
Numeric Change and percent change in PSA
Measured: from baseline to 12 months of treatment
safety evaluation : incidence and severity of adverse events
Measured: 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completionDec 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301599
- Sponsor's protocol ID
- 2009-09-024
- Status last verified
- Nov 2019
- First submitted
- 21 Feb 2011
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Alpha Blocker Monotherapy and 5-alpha-reductase Inhibitor Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT01301599
- Acronym / sponsor ID
- 2009-09-024
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia, alpha blocker, 5-alpha reductase inhibitor, combination therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Feb 2011 (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.
This study is designed to investigate the comparison between alpha blocker monotherapy and 5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic hyperplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combination group | Experimental | Drug: combination therapycombination therapy of alpha blocker and 5-alpha-reductase inhibitor medication |
| alpha blocker group | Active comparator | Drug: alpha blocker monotherapyalpha blocker monotherapy |
| 5 ARI group | Active comparator | Drug: 5 alpha reductase inhibitor monotherapy5 alpha-reductase inhibitor group |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male aged 45 years old and above (with no upper limit of age)
- patients who underwent combination therapy of alpha blocker and 5 ARI for more than 9 months
- IPSS ≤ 12
- Ability and willingness to correctly complete the micturition diary and questionnaire
- Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
Key exclusion criteria (10 listed)
- An anticholinergic or antidiuretic if started less than 3 months prior to screening
- Patients who had surgical treatment due to LUTS
- Patients with suspected neurogenic bladder disorder
- Patients with cancer of any type including cancer of the prostate or bladder
- Patients with urethral stricture or bladder neck contracture
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 |
|---|---|---|
| combination therapyalpha blocker and 5-alpha-reductase inhibitor medication | Drug | combination group |
| alpha blocker monotherapyalpha blocker monotherapy group | Drug | alpha blocker group |
| 5 alpha reductase inhibitor monotherapy5 alpha reductase inhibitor monotherapy | Drug | 5 ARI group |
Primary outcome
Numeric change of IPS and Numeric change of IPSS total score
Time frame: from baseline to 12 months of treatment
5 secondary outcomes
Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS
Time frame: from baseline to 12 months of treatment
Changes in urodynamic parameters : maximal flow rate and PVR
Time frame: from baseline to 12 months of treatment
change in finding of TRUS
Time frame: from baseline to 12 months of treatment
Numeric Change and percent change in PSA
Time frame: from baseline to 12 months of treatment
safety evaluation : incidence and severity of adverse events
Time frame: 12 months of 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 2 Dec 2019.
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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.
Kyu-Sung Lee, Ph.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 Phase 4 study testing combination therapy, alpha blocker monotherapy and 5 alpha reductase inhibitor monotherapy 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 5 inclusion and 10 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 2 Dec 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Numeric change of IPS and Numeric change of IPSS total score (time frame: from baseline to 12 months of 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 2 Dec 2019; AzTrials last refreshed its copy on 2 Nov 2026.