Benign Prostatic Hyperplasia (BPH) Clinical Trial
Official title:
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Ozarelix, in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy of ozarelix compared to placebo in the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in men as assessed by the International Prostate Symptom Score (IPSS) at Week 14.
This is a multi-center, randomized, double-blind, placebo-controlled study. Participants who meet the entry IPSS inclusion criteria at Week 0 will be randomized and enroll in the double-blind treatment period. Participants will be randomized to one of three treatment arms and will receive two 6-month courses of study drug administered on Days 0 and 14 of each 6-month course. Treatment arms include: ozarelix 30mg + 15mg, ozarelix 15mg + 15mg or placebo + placebo. Safety and efficacy assessments will be performed at defined intervals throughout the study. At Week 52 all participants on study will be eligible to receive ozarelix for two additional courses in the open-label treatment period. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03052049 -
Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres
|
N/A | |
| Recruiting |
NCT04757116 -
Post-Market Study to Assess iTind Safety in Comparison to UroLift
|
N/A | |
| Completed |
NCT03460873 -
Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate
|
||
| Completed |
NCT01218243 -
An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia
|
Phase 2 | |
| Completed |
NCT01566292 -
Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT00407953 -
PROLIEVE® Post-Marketing Study TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
|
Phase 4 | |
| Completed |
NCT03191734 -
French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
|
N/A | |
| Recruiting |
NCT04838769 -
REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men
|
N/A | |
| Completed |
NCT03856242 -
Benign Prostatic Hyperplasia and Ischemic Heart DIsease
|
Phase 4 | |
| Completed |
NCT04032067 -
Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)
|
Phase 3 | |
| Completed |
NCT02505919 -
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)
|
N/A | |
| Completed |
NCT02855892 -
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH
|
Phase 2 | |
| Completed |
NCT02145208 -
Study to Assess the Efficacy of Medi-Tate iTind Device
|
N/A | |
| Completed |
NCT00970632 -
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia
|
Phase 3 | |
| Recruiting |
NCT02592473 -
Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia
|
N/A | |
| Completed |
NCT00945490 -
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
|
Phase 3 | |
| Completed |
NCT00759135 -
Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)
|
Phase 2 | |
| Completed |
NCT00224107 -
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
|
Phase 3 | |
| Recruiting |
NCT04648176 -
Application of MOSES Technology in BPH
|
N/A | |
| Terminated |
NCT00651807 -
A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806)
|
Phase 2 |