[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659965":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":54,"studyPopulation":42,"armGroups":55,"interventions":72,"overallOfficials":42,"centralContacts":82,"locations":42,"responsibleParty":88,"collaborators":42,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":42,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":42,"enrollmentInfo":99,"targetDuration":42,"studyType":102,"phases":103,"briefSummary":94,"conditions":105,"keywords":107,"overallStatus":109,"whyStopped":42,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":42},{"fullName":5,"class":6},"Il-Yang Pharm. Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Total IPSS","Change from baseline in total International Prostate Symptom Score (total IPSS) at Week 48 after treatment","Baseline to week 48",[14,17,21,25,28,32,36,39],{"measure":10,"description":15,"timeFrame":16},"Change from baseline in total International Prostate Symptom Score (total IPSS) at Weeks 4, 12, 24, and 36 after treatment","Baseline to Weeks 4, 12, 24 and 36",{"measure":18,"description":19,"timeFrame":20},"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","Baseline to Weeks 4, 12, 24, 36 and 48",{"measure":22,"description":23,"timeFrame":24},"IPSS Voiding Symptoms","Change from baseline in the IPSS voiding symptom domain score at Weeks 4, 12, 24, 36, and 48 after treatment","Baseline to Weeks 4, 12, 24, 36, and 48",{"measure":26,"description":27,"timeFrame":24},"IPSS Storage Symptoms","Change from baseline in the IPSS storage symptom domain score at Weeks 4, 12, 24, 36, and 48 after treatment",{"measure":29,"description":30,"timeFrame":31},"Prostate Volume","Change from baseline in prostate volume at Week 48 after treatment","Baseline to Week 48",{"measure":33,"description":34,"timeFrame":35},"Maximum Urinary Flow Rate (Qmax)","Change from baseline in maximum urinary flow rate (Qmax) at Weeks 24 and 48 after treatment","Baseline to Weeks 24 and 48",{"measure":37,"description":38,"timeFrame":35},"Postvoid Residual Urine Volume (PVR)","Change from baseline in postvoid residual urine volume (PVR) at Weeks 24 and 48 after treatment",{"measure":40,"description":41,"timeFrame":35},"Serum PSA","Change from baseline in serum prostate-specific antigen (PSA) level at Weeks 24 and 48 after treatment",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":48,"maskingDescription":42,"whoMasked":49},"QUADRUPLE",[50,51,52,53],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nParticipants 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.",[56,63,68],{"label":57,"type":58,"description":59,"interventionNames":60},"Treatment","EXPERIMENTAL","Finasteride+Tamsulosin",[61,62],"Drug: Finasteride 5 mg Tablet, single dose","Drug: Tamsulosin 0.4Mg Capsule",{"label":64,"type":65,"description":66,"interventionNames":67},"Comparator 1","ACTIVE_COMPARATOR","Finasteride",[61],{"label":69,"type":65,"description":70,"interventionNames":71},"Comparator 2","Tamsulosin",[62],[73,78],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":42},"DRUG","Finasteride 5 mg Tablet, single dose","Finasteride 5mg administered orally once daily",[64,57],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":42},"Tamsulosin 0.4Mg Capsule","Tamsulosin 0.4mg capsule administered orally once daily",[69,57],[83],{"name":84,"role":85,"phone":86,"phoneExt":42,"email":87},"SukWoong Kang, Sr. Researcher","CONTACT","+82-2-570-3779","swkang1@ilyang.co.kr",{"type":89,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100659965","phase-3-efficacy-and-safety-of-combination-therapy-compared-with-monotherapy-in-patients-with-benign-prostatic-hyperplasia-100659965",false,"NCT07870759","Efficacy and Safety of Combination Therapy Compared With Monotherapy in Patients With Benign Prostatic Hyperplasia","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","Inclusion Criteria:\n\n* Screening Eligibility Criteria:\n\n  1. Men aged 45 years or older.\n  2. Participants diagnosed with benign prostatic hyperplasia (BPH).\n  3. Prostate volume of ≥30 mL as measured by transrectal ultrasonography (TRUS).\n  4. Participants considered capable of completing the questionnaires.\n  5. Participants who voluntarily agree to participate in the clinical trial and - provide written informed consent.\n* Randomization Eligibility Criteria\n\n  1. Total International Prostate Symptom Score (total IPSS) of ≥13 points.\n  2. Maximum urinary flow rate (Qmax) of ≥4 mL\u002Fsec and ≤15 mL\u002Fsec, with a minimum voided volume of ≥125 mL.\n  3. Postvoid residual urine volume (PVR) of \\\u003C200 mL.\n\nExclusion Criteria:\n\n1. Participants with hypersensitivity to the investigational medicinal product, its components, or sulfonamides.\n2. Participants with any of the following medical histories:\n\n   * Malignancy of the pelvic organs (bladder, prostate, or rectum).\n   * Prostate surgery or other invasive procedures (e.g., robotic simple prostatectomy, radiofrequency therapy, or minimally invasive treatment).\n   * Urethrotomy or other surgery that may affect urinary flow, or pelvic surgery.\n   * Lower urinary tract instrumentation within 4 weeks prior to screening.\n   * Acute urinary retention within 12 weeks prior to screening.\n   * Symptomatic orthostatic hypotension.\n   * Known alcohol or drug abuse.\n3. Participants with any of the following comorbidities:\n\n   * Major depressive disorder.\n   * Clinically significant arrhythmia.\n   * Uncontrolled hypertension (systolic blood pressure \\>170 mm Hg or diastolic blood pressure \\>100 mm Hg).\n   * Uncontrolled hypotension (systolic blood pressure \\\u003C90 mm Hg or diastolic blood pressure \\\u003C50 mm Hg).\n   * Uncontrolled diabetes mellitus (HbA1c \\>9.0%).\n   * Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.\n   * Severe renal impairment (estimated glomerular filtration rate \\[eGFR\\] \\\u003C30 mL\u002Fmin according to the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation).\n   * Severe hepatic impairment (AST and\u002For ALT \\>3 × ULN).\n   * 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).\n4. PSA \\>4.0 ng\u002FmL, unless a prostate biopsy performed within 6 months prior to randomization confirms the absence of prostate cancer.\n5. 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.\n6. Participants who have received or are receiving any of the following medications or foods within the specified periods prior to randomization:\n\n   * α-blockers (tamsulosin, terazosin, doxazosin, alfuzosin, etc.): within 4 weeks prior to randomization.\n   * PDE5 inhibitors (tadalafil, sildenafil, vardenafil, udenafil, mirodenafil, avanafil, etc.): within 4 weeks prior to randomization.\n   * 5α-reductase inhibitors (finasteride, dutasteride):\n\n     1. Finasteride: within 12 weeks prior to randomization.\n     2. Dutasteride: within 24 weeks prior to randomization.\n   * Antimuscarinic\u002Fanticholinergic agents (oxybutynin, propiverine, solifenacin, tolterodine, trospium, etc.): within 4 weeks prior to randomization.\n   * β3-adrenergic agonists (mirabegron, vibegron): within 4 weeks prior to randomization.\n   * Progestogen preparations: within 24 weeks prior to randomization.\n   * Medications with antiandrogenic effects other than progestogen preparations (spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, etc.): within 24 weeks prior to randomization.\n   * Strong CYP3A4 inducers (carbamazepine, phenytoin, rifampin, St. John's wort, etc.): within 4 weeks prior to randomization.\n   * Strong CYP3A4 inhibitors (clarithromycin, lopinavir\u002Fritonavir, ritonavir, ketoconazole, itraconazole, grapefruit, grapefruit juice, etc.): within 4 weeks prior to randomization.\n   * Desmopressin: within 4 weeks prior to randomization.\n   * Cholinergic agents (bethanechol, carbachol, etc.): within 4 weeks prior to randomization.\n7. 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.\n8. 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.\n9. Participants who intend to donate blood during the clinical trial or for 30 days after the last administration of the investigational medicinal product.\n10. Participants who are considered unsuitable for participation in the clinical trial by the investigator for other reasons.","MALE","45 Years",{"count":100,"type":101},660,"ESTIMATED","INTERVENTIONAL",[104],"PHASE3",[106],"Benign Prostatic Hyperplasia",[108],"BPH","NOT_YET_RECRUITING","2026-10-06",{"date":112,"type":113},"2026-10-13","ACTUAL",{"date":115,"type":101},"2026-11-09",{"date":117,"type":101},"2027-08-31",{"name":5,"class":6}]