64 completed, 9 terminated, 7 not yet recruiting, 6 unknown. 88 Phase 3, 8 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 88 | Completed 64, Terminated 9, Not yet recruiting 7, Unknown 6, Withdrawn 2 |
| Phase 2 | 8 | Completed 8 |
Follow Prostatic Hyperplasia: new trials by email Literature Review of Prostatic Hyperplasia trials Research Report on Prostatic Hyperplasia
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Combination Therapy Compared With Monotherapy in Patients With Benign Prostatic Hyperplasia Finasteride 5 mg Tablet, single dose, Tamsulosin 0.4Mg Capsule - Benign Prostatic Hyperplasia | Phase 3 | Not yet recruiting | Il-Yang Pharm. Co., Ltd. | 660 | 2026-11-09 | 2026-10-13 |
| Randomized Controlled Trial of Different Antibiotic Duration Prior to Prostate Enucleation Surgery antibiotic prophylaxis - BPH With Urinary Obstruction, Antibiotic Prophylaxis | Phase 3 | Not yet recruiting | Ohio State University | 250 | 2026-01-01 | 2025-10-06 |
| Efficacy/ Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia Product DNN.65.21.005, Combodart® - Prostatic Hyperplasia, Benign | Phase 3 | Not yet recruiting | Ache Laboratorios Farmaceuticos S.A. | 218 | 2026-01-01 | 2025-12-08 |
| Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia Methoxyflurane - Penthrox, Control, Percocet Pill - Benign Prostate Hypertrophy(BPH) | Phase 3 | Not yet recruiting | University of Manitoba | 48 | 2025-08-01 | 2025-06-12 |
| A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia H077 sustained-release tablet, Silodosin capsules Control Group - Benign Prostatic Hyperplasia, Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms | Phase 3 | Not yet recruiting | Shanghai Huilun Pharmaceutical Co., Ltd. | 728 | 2025-08-01 | 2025-08-28 |
| Investigating the Adjunctive Use of Mirabegron in the Early Post-Rezum Procedure Period Beta-3 agonists (Mirabegron/Myrbetriq), Placebo group post rezum - Benign Prostate Hypertrophy(BPH) | Phase 3 | Not yet recruiting | University of Manitoba | 50 | 2025-08-01 | 2025-06-12 |
| Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia DTT106, Dutasteride-Tamsulosin - Prostatic Hyperplasia, Benign, Erectile Dysfunction | Phase 3 | Not yet recruiting | EMS | 262 | 2025-02-01 | 2024-02-20 |
| Outcomes of MIST for BPH: A Single-Institution Prospective Study Rezum, iTind - Benign Prostatic Hyperplasia | Phase 3 | Unknown | University of Manitoba | 20 | 2024-03-01 | 2024-02-23 |
| Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH Prostatic Artery Embolization (PAE), Pharmacotherapy - Benign Prostatic Hyperplasia, Pharmacotherapy | Phase 3 | Unknown | Dominik Abt | 425 | 2021-09-01 | 2021-01-26 |
| PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia Prostate Artery Embolization, Sham Prostate Artery Embolization - Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms | Phase 3 | Unknown | Society of Interventional Radiology Foundation | 108 | 2021-08-01 | 2021-03-19 |
| Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia DKF-313, Dutasteride, Tadalafil - Benign Prostatic Hyperplasia | Phase 3 | Completed | Dongkook Pharmaceutical Co., Ltd. | 667 | 2021-07-27 | 2023-09-21 |
| The Effectiveness of Spermotrend Food Supplement in the Treatment of Male Infertility Spermotrend - Male Infertility, Benign Prostatic Hyperplasia | Phase 2 / Phase 3 | Completed | Catalysis SL | 150 | 2021-06-15 | 2023-03-28 |
| Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia Tanzânia association, Omnic Ocas, Omnic Ocas placebo - Erectile Dysfunction, Benign Prostatic Hyperplasia | Phase 3 | Completed | EMS | 295 | 2021-03-14 | 2025-12-08 |
| Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH alpha-blocker or 5-ARI withdrawal, Maintenance of alpha-blocker and 5-ARI - Prostatic Hyperplasia, Prostate Hyperplasia | Phase 3 | Unknown | Gangnam Severance Hospital | 300 | 2020-12-08 | 2021-08-27 |
| Composite Steep-pulseTreatment Device Used in Patients With Benign Prostatic Hyperplasia Composite Steep-pulse Treatment Device, Tamsulosin Hydrochloride Capsules - Benign Prostatic Hyperplasia | Phase 2 / Phase 3 | Completed | REMD Medical Technology | 160 | 2020-08-20 | 2022-09-07 |
| A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial Moses laser enucleation of prostate - Benign Prostatic Hyperplasia | Phase 3 | Completed | Vanderbilt University Medical Center | 60 | 2020-01-01 | 2022-03-31 |
| Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH) GV1001 placebo, Proscar placebo - Benign Prostatic Hyperplasia (BPH) | Phase 3 | Completed | GemVax & Kael | 423 | 2019-10-30 | 2022-08-25 |
| Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia Vibegron - Overactive Bladder | Phase 3 | Completed | Urovant Sciences GmbH | 276 | 2019-09-19 | 2024-08-21 |
| Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH) Vibegron, Placebo - Overactive Bladder | Phase 3 | Completed | Urovant Sciences GmbH | 1105 | 2019-03-26 | 2024-08-07 |
| HoLEP Vs BPEP for Large Prostatic Adenoma Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia - Prostate Hyperplasia | Phase 3 | Completed | Ahmed Maher Gamil Ahmed Higazy | 100 | 2018-02-01 | 2020-06-16 |
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Lower Urinary Tract Symptoms (13) · Erectile Dysfunction (5) · Hyperplasia (3) · Prostatic Neoplasms (2) · Urinary Bladder Neck Obstruction (2) · Urinary Bladder, Overactive (2) · Urinary Retention (2) · Genital Diseases, Male (1) · Infertility, Male (1) · Metabolic Syndrome (1) · Neoplasms (1) · Nocturia (1) · Prostatic Diseases (1) · Prostatitis (1)
Genital Diseases (88) · Male Urogenital Diseases (88) · Urogenital Diseases (88) · Genital Diseases, Male (87) · Prostatic Diseases (87) · Pathological Conditions, Signs and Symptoms (20) · Signs and Symptoms (17) · Urological Manifestations (17) · Female Urogenital Diseases (7) · Female Urogenital Diseases and Pregnancy Complications (7) · Urologic Diseases (7) · Mental Disorders (5) · Sexual Dysfunction, Physiological (5) · Sexual Dysfunctions, Psychological (5) · Lower Urinary Tract Symptoms (4)
Tamsulosin (19) · Tadalafil (13) · Finasteride (8) · Dutasteride (7) · alfuzosin (6) · silodosin (5) · Solifenacin Succinate (4) · fexapotide (4) · Drug Therapy (2) · N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide (2) · Transurethral Resection of Prostate (2) · cetrorelix (2) · Adrenergic alpha-Antagonists (1) · Antibiotic Prophylaxis (1) · Biofeedback, Psychology (1)
Eli Lilly and Company (10) · Sanofi (6) · GlaxoSmithKline (5) · Health Ever Bio-Tech Co., Ltd. (5) · Nymox Corporation (4) · AEterna Zentaris (3) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (3) · University of Manitoba (3) · Watson Pharmaceuticals (3) · Astellas Pharma Europe B.V. (2) · EMS (2) · Hanmi Pharmaceutical Company Limited (2) · IlDong Pharmaceutical Co Ltd (2) · Urovant Sciences GmbH (2) · Aberdeen Royal Infirmary (1)
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PMID 26299520, PMID 21135869, PMID 23234617, PMID 11796283, PMID 12689743, PMID 12893330, PMID 14499682, PMID 14681504, PMID 16467543, PMID 16536764, PMID 18355417, PMID 18542722, PMID 18722631, PMID 19371887, PMID 19409693, PMID 19815265, PMID 20163842, PMID 21109344, PMID 21871706, PMID 22017520, PMID 22297243, PMID 23346990, PMID 24119319, PMID 24571205, PMID 24938580, PMID 25353053, PMID 25712312, PMID 26945662, PMID 29383480, PMID 29490509, PMID 30680237, PMID 37070660, PMID 37415648, PMID 40683564, PMID 41363221
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