Benign Prostatic HyperplasiaPhase 3NCT07870759
Efficacy and Safety of Combination Therapy Compared With Monotherapy in Patients With Benign Prostatic Hyperplasia
A Phase 3 study testing Finasteride 5 mg Tablet, single dose and Tamsulosin 0.4Mg Capsule in people with Benign Prostatic Hyperplasia, run by Il-Yang Pharm. Co., Ltd..
Trial summary
Efficacy and Safety of Combination Therapy Compared With Monotherapy in Patients With 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?
- Finasteride 5 mg Tablet, single dose and Tamsulosin 0.4Mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- No sites listed yet
- Study dates
- 9 Nov 2026to 31 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Screening Eligibility Criteria:
- Men aged 45 years or older.
- Participants diagnosed with benign prostatic hyperplasia (BPH).
- Prostate volume of ≥30 mL as measured by transrectal ultrasonography (TRUS).
- Participants considered capable of completing the questionnaires.
- Participants who voluntarily agree to participate in the clinical trial and - provide written informed consent.
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- Randomization Eligibility Criteria
- Total International Prostate Symptom Score (total IPSS) of ≥13 points.
- Maximum urinary flow rate (Qmax) of ≥4 mL/sec and ≤15 mL/sec, with a minimum voided volume of ≥125 mL.
- Postvoid residual urine volume (PVR) of <200 mL.
Who cannot join
- Participants with hypersensitivity to the investigational medicinal product, its components, or sulfonamides.
- Participants with any of the following medical histories:
- Malignancy of the pelvic organs (bladder, prostate, or rectum).
- Prostate surgery or other invasive procedures (e.g., robotic simple prostatectomy, radiofrequency therapy, or minimally invasive treatment).
- Urethrotomy or other surgery that may affect urinary flow, or pelvic surgery.
- Lower urinary tract instrumentation within 4 weeks prior to screening.
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- Acute urinary retention within 12 weeks prior to screening.
- Symptomatic orthostatic hypotension.
- Known alcohol or drug abuse.
- Participants with any of the following comorbidities:
- Major depressive disorder.
- Clinically significant arrhythmia.
- Uncontrolled hypertension (systolic blood pressure >170 mm Hg or diastolic blood pressure >100 mm Hg).
- Uncontrolled hypotension (systolic blood pressure <90 mm Hg or diastolic blood pressure <50 mm Hg).
- Uncontrolled diabetes mellitus (HbA1c >9.0%).
- Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min according to the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation).
- Severe hepatic impairment (AST and/or ALT >3 × ULN).
- Conditions other than BPH that may cause voiding dysfunction or changes in urinary flow (e.g., neurogenic bladder, bladder neck sclerosis, urethral stricture, bladder tumor, acute or chronic prostatitis, or acute or chronic urinary tract infection).
- PSA >4.0 ng/mL, unless a prostate biopsy performed within 6 months prior to randomization confirms the absence of prostate cancer.
- Participants who underwent a prostate biopsy within 4 weeks prior to screening. Participants may be eligible if more than 4 weeks have elapsed since the biopsy.
- Participants who have received or are receiving any of the following medications or foods within the specified periods prior to randomization:
- α-blockers (tamsulosin, terazosin, doxazosin, alfuzosin, etc.): within 4 weeks prior to randomization.
- PDE5 inhibitors (tadalafil, sildenafil, vardenafil, udenafil, mirodenafil, avanafil, etc.): within 4 weeks prior to randomization.
- 5α-reductase inhibitors (finasteride, dutasteride):
- Finasteride: within 12 weeks prior to randomization.
- Dutasteride: within 24 weeks prior to randomization.
- Antimuscarinic/anticholinergic agents (oxybutynin, propiverine, solifenacin, tolterodine, trospium, etc.): within 4 weeks prior to randomization.
- β3-adrenergic agonists (mirabegron, vibegron): within 4 weeks prior to randomization.
- Progestogen preparations: within 24 weeks prior to randomization.
- Medications with antiandrogenic effects other than progestogen preparations (spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, etc.): within 24 weeks prior to randomization.
- Strong CYP3A4 inducers (carbamazepine, phenytoin, rifampin, St. John's wort, etc.): within 4 weeks prior to randomization.
- Strong CYP3A4 inhibitors (clarithromycin, lopinavir/ritonavir, ritonavir, ketoconazole, itraconazole, grapefruit, grapefruit juice, etc.): within 4 weeks prior to randomization.
- Desmopressin: within 4 weeks prior to randomization.
- Cholinergic agents (bethanechol, carbachol, etc.): within 4 weeks prior to randomization.
- Participants who have received an investigational medicinal product or investigational medical device within 4 weeks or 5 half-lives, whichever is longer, prior to screening.
- Participants who do not agree to use the contraception methods permitted in this clinical trial (see Section 8.4.6.1) or to refrain from sperm donation during the clinical trial and for 30 days after the last administration of the investigational medicinal product.
- Participants who intend to donate blood during the clinical trial or for 30 days after the last administration of the investigational medicinal product.
- Participants who are considered unsuitable for participation in the clinical trial by the investigator for other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial to Compare the Efficacy and Safety of UROCOM-R1 Plus UROCOM-R2 Combination Therapy Versus UROCOM-R1 or UROCOM-R2 Monotherapy in Patients With Benign Prostatic Hyperplasia
Efficacy and Safety of Combination Therapy Compared With Monotherapy in Patients With Benign Prostatic Hyperplasia
Read the detailed description
Benign prostatic hyperplasia (BPH) is a common condition in men that can cause lower urinary tract symptoms, including difficulty urinating, weak urinary stream, urinary frequency, and nocturia. This study is designed to evaluate the efficacy and safety of combination therapy with finasteride and tamsulosin compared with monotherapy in patients with BPH.
Participants will be randomly assigned to receive either combination therapy with finasteride and tamsulosin, finasteride monotherapy, or tamsulosin monotherapy. The efficacy of the treatments will be evaluated by changes in urinary symptoms and other clinical measures, including the International Prostate Symptom Score (IPSS), prostate volume, maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), and serum prostate-specific antigen (PSA) level. Safety will also be evaluated throughout the study.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Finasteride 5 mg Tablet, single dose, Tamsulosin 0.4Mg Capsule
- Keywords
- BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finasteride 5 mg Tablet, single doseDrug
Finasteride 5mg administered orally once daily
Tamsulosin 0.4Mg CapsuleDrug
Tamsulosin 0.4mg capsule administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Finasteride+Tamsulosin Receives: Drug: Finasteride 5 mg Tablet, single dose; Drug: Tamsulosin 0.4Mg Capsule |
| Comparator 1 | Active comparator | Finasteride Receives: Drug: Finasteride 5 mg Tablet, single dose |
| Comparator 2 | Active comparator | Tamsulosin Receives: Drug: Tamsulosin 0.4Mg Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total IPSS
Change from baseline in total International Prostate Symptom Score (total IPSS) at Week 48 after treatment
Measured: Baseline to week 48
Secondary outcomes (8)
Total IPSS
Change from baseline in total International Prostate Symptom Score (total IPSS) at Weeks 4, 12, 24, and 36 after treatment
Measured: Baseline to Weeks 4, 12, 24 and 36
IPSS Quality of Life
Change from baseline in the International Prostate Symptom Score (IPSS) quality of life (QoL) score at Weeks 4, 12, 24, 36, and 48 after treatment
Measured: Baseline to Weeks 4, 12, 24, 36 and 48
IPSS Voiding Symptoms
Change from baseline in the IPSS voiding symptom domain score at Weeks 4, 12, 24, 36, and 48 after treatment
Measured: Baseline to Weeks 4, 12, 24, 36, and 48
IPSS Storage Symptoms
Change from baseline in the IPSS storage symptom domain score at Weeks 4, 12, 24, 36, and 48 after treatment
Measured: Baseline to Weeks 4, 12, 24, 36, and 48
Prostate Volume
Change from baseline in prostate volume at Week 48 after treatment
Measured: Baseline to Week 48
Maximum Urinary Flow Rate (Qmax)
Change from baseline in maximum urinary flow rate (Qmax) at Weeks 24 and 48 after treatment
Measured: Baseline to Weeks 24 and 48
Postvoid Residual Urine Volume (PVR)
Change from baseline in postvoid residual urine volume (PVR) at Weeks 24 and 48 after treatment
Measured: Baseline to Weeks 24 and 48
Serum PSA
Change from baseline in serum prostate-specific antigen (PSA) level at Weeks 24 and 48 after treatment
Measured: Baseline to Weeks 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start9 Nov 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870759
- Sponsor's protocol ID
- IY-UROCOM
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor does not plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial to Compare the Efficacy and Safety of UROCOM-R1 Plus UROCOM-R2 Combination Therapy Versus UROCOM-R1 or UROCOM-R2 Monotherapy in Patients With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT07870759
- Acronym / sponsor ID
- IY-UROCOM
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- 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.
Efficacy and Safety of Combination Therapy Compared With Monotherapy in Patients With Benign Prostatic Hyperplasia
Detailed description
Benign prostatic hyperplasia (BPH) is a common condition in men that can cause lower urinary tract symptoms, including difficulty urinating, weak urinary stream, urinary frequency, and nocturia. This study is designed to evaluate the efficacy and safety of combination therapy with finasteride and tamsulosin compared with monotherapy in patients with BPH.
Participants will be randomly assigned to receive either combination therapy with finasteride and tamsulosin, finasteride monotherapy, or tamsulosin monotherapy. The efficacy of the treatments will be evaluated by changes in urinary symptoms and other clinical measures, including the International Prostate Symptom Score (IPSS), prostate volume, maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), and serum prostate-specific antigen (PSA) level. Safety will also be evaluated throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Finasteride 5 mg Tablet, single dose, Drug: Tamsulosin 0.4Mg CapsuleFinasteride+Tamsulosin |
| Comparator 1 | Active comparator | Drug: Finasteride 5 mg Tablet, single doseFinasteride |
| Comparator 2 | Active comparator | Drug: Tamsulosin 0.4Mg CapsuleTamsulosin |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Screening Eligibility Criteria:
- Randomization Eligibility Criteria
Key exclusion criteria (39 listed)
- Participants with hypersensitivity to the investigational medicinal product, its components, or sulfonamides.
- Participants with any of the following medical histories:
- Participants with any of the following comorbidities:
- PSA >4.0 ng/mL, unless a prostate biopsy performed within 6 months prior to randomization confirms the absence of prostate cancer.
- Participants who underwent a prostate biopsy within 4 weeks prior to screening. Participants may be eligible if more than 4 weeks have elapsed since the biopsy.
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 |
|---|---|---|
| Finasteride 5 mg Tablet, single doseFinasteride 5mg administered orally once daily | Drug | Comparator 1, Treatment |
| Tamsulosin 0.4Mg CapsuleTamsulosin 0.4mg capsule administered orally once daily | Drug | Comparator 2, Treatment |
Primary outcome
Total IPSS
Time frame: Baseline to week 48
Change from baseline in total International Prostate Symptom Score (total IPSS) at Week 48 after treatment
8 secondary outcomes
Total IPSS
Time frame: Baseline to Weeks 4, 12, 24 and 36
IPSS Quality of Life
Time frame: Baseline to Weeks 4, 12, 24, 36 and 48
IPSS Voiding Symptoms
Time frame: Baseline to Weeks 4, 12, 24, 36, and 48
IPSS Storage Symptoms
Time frame: Baseline to Weeks 4, 12, 24, 36, and 48
Prostate Volume
Time frame: Baseline to Week 48
Maximum Urinary Flow Rate (Qmax)
Time frame: Baseline to Weeks 24 and 48
Postvoid Residual Urine Volume (PVR)
Time frame: Baseline to Weeks 24 and 48
Serum PSA
Time frame: Baseline to Weeks 24 and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. The sponsor does not plan to make individual participant data (IPD) available to other researchers.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Finasteride 5 mg Tablet, single dose and Tamsulosin 0.4Mg Capsule in people with Benign Prostatic Hyperplasia, run by Il-Yang Pharm. Co., Ltd..
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 10 inclusion and 39 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: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SukWoong Kang, Sr. Researcher (+82-2-570-3779, swkang1@ilyang.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total IPSS (time frame: Baseline to week 48). 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 13 Oct 2026.