37 completed, 7 terminated, 4 unknown, 2 not yet recruiting. 51 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 51 | Completed 37, Terminated 7, Unknown 4, Not yet recruiting 2, Withdrawn 1 |
| Phase 2 | 4 | Completed 4 |
Follow Benign Prostatic Hyperplasia: new trials by email Literature Review of Benign Prostatic Hyperplasia trials Research Report on Benign 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 |
| 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 |
| 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 |
| 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 |
| Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia Embosphere® (Prostatic Arteries Embolization), Drug therapy - Benign Prostatic Hyperplasia | Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 90 | 2016-08-01 | 2022-05-03 |
| The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction Tamsulosin 0.2mg, Tadalafil 5mg, Placebo for Tamsulosin - Benign Prostatic Hyperplasia, Erectile Dysfunction | Phase 3 | Unknown | IlDong Pharmaceutical Co Ltd | 330 | 2016-03-01 | 2016-08-12 |
| Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH Tamsulosin 0.2mg + Solifenacin 5mg, Tamsulosin 0.2mg + Placebo(Solifenacin) - Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia | Phase 3 | Completed | Jeil Pharmaceutical Co., Ltd. | 780 | 2016-02-01 | 2019-08-29 |
| Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients Tamsulosin 0.2mg, Tadalafil 5mg - Benign Prostatic Hyperplasia | Phase 3 | Completed | Chong Kun Dang Pharmaceutical | 455 | 2015-09-01 | 2017-08-11 |
| A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules HCP1303 capsule 5/0.2mg, HCP1303 capsule 5/0.4mg, HGP1201 - Benign Prostatic Hyperplasia | Phase 3 | Completed | Hanmi Pharmaceutical Company Limited | 510 | 2015-03-01 | 2016-10-13 |
| Results of Selective Prostatic Arterial Embolization in Patients With Indwelling Urinary Catheter Due to Benign Prostatic Hyperplasia Refractory to Medical Treatment. Prostatic arterial embolization using BeadBlock (Terumo) - Benign Prostatic Hyperplasia | Phase 3 | Terminated | University Hospital, Rouen | 2 | 2014-05-01 | 2015-07-30 |
| Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS Tamsulosin HCL 0.4mg, Tamsulosin HCL 0.2mg - Benign Prostatic Hyperplasia | Phase 3 | Completed | GL Pharm Tech Corporation | 309 | 2014-03-01 | 2016-02-25 |
| Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH PRX302, Placebo - Benign Prostatic Hyperplasia | Phase 3 | Completed | Sophiris Bio Corp | 479 | 2013-10-01 | 2017-04-27 |
| Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2) Finasteride, Tamsulosin, Finasteride-matching placebo - Benign Prostatic Hyperplasia | Phase 3 | Terminated | Merck Sharp & Dohme LLC | 1 | 2013-08-01 | 2018-08-29 |
| Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022) NX-1207 - Benign Prostatic Hyperplasia, BPH | Phase 3 | Completed | Nymox Corporation | 160 | 2013-04-01 | 2017-03-10 |
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Prostatic Hyperplasia (51) · Lower Urinary Tract Symptoms (13) · Erectile Dysfunction (3) · Hyperplasia (2) · Urinary Bladder Neck Obstruction (2) · Genital Diseases, Male (1) · Infertility, Male (1) · Prostatic Diseases (1) · Signs and Symptoms (1)
Genital Diseases (51) · Male Urogenital Diseases (51) · Urogenital Diseases (51) · Genital Diseases, Male (50) · Prostatic Diseases (50) · Pathological Conditions, Signs and Symptoms (15) · Signs and Symptoms (13) · Urological Manifestations (13) · Mental Disorders (3) · Sexual Dysfunction, Physiological (3) · Sexual Dysfunctions, Psychological (3) · Female Urogenital Diseases (2) · Female Urogenital Diseases and Pregnancy Complications (2) · Pathologic Processes (2) · Urethral Diseases (2)
Tamsulosin (12) · Tadalafil (11) · Finasteride (6) · Dutasteride (4) · silodosin (4) · Solifenacin Succinate (3) · fexapotide (3) · Drug Therapy (2) · alfuzosin (2) · Control Groups (1) · Duration of Therapy (1) · PRX302 (1) · Tablets (1) · Therapeutics (1) · Transurethral Resection of Prostate (1)
Eli Lilly and Company (8) · Health Ever Bio-Tech Co., Ltd. (5) · Nymox Corporation (3) · Astellas Pharma Europe B.V. (2) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (2) · Sanofi (2) · Watson Pharmaceuticals (2) · Assistance Publique - Hôpitaux de Paris (1) · Catalysis SL (1) · Chong Kun Dang Pharmaceutical (1) · Dominik Abt (1) · Dongkook Pharmaceutical Co., Ltd. (1) · Dr. J. Curtis Nickel (1) · EMS (1) · GL Pharm Tech Corporation (1)
United States (18) · Italy (7) · Canada (6) · France (6) · Germany (6) · South Korea (6) · Russia (5) · Poland (4) · Taiwan (4) · Austria (3) · Belgium (3) · China (3) · Japan (3) · Mexico (3) · United Kingdom (3)
Allan J Pantuck, MD, MS, FACS (2) · Yeong-Shiau Pu, MD, PhD (2) · Andrew Avins, MD, MPH (1) · Choung-Soo Kim, M.D.,Ph.D (1) · Christopher Re Chapple, BSc MD (1) · Dominik Abt, MD (1) · Howard Evans, MD (1) · J. Curtis Nickel, MD FRCSC (1) · Jafar Golzarian, MD (1)
PMID 26299520, PMID 16467543, PMID 18355417, PMID 18722631, PMID 19409693, PMID 19815265, PMID 20163842, PMID 21109344, PMID 21135869, PMID 21871706, PMID 22017520, PMID 23234617, PMID 24119319, PMID 24571205, PMID 24938580, PMID 25353053, PMID 25712312, PMID 30680237, PMID 37415648
2008 (2), R01DK056199 (1), U01DK060817 (1)