Clinical Trials Logo

Clinical Trial Summary

This study is to compare the efficacy and safety of ozarelix 15 mg given intramuscular (IM) 2 weeks apart on the improvement of symptoms and the duration of improvement for up to 6 months in men with Benign Prostatic Hypertrophy (BPH) who are over 50 years of age.


Clinical Trial Description

This study is to compare the improvement in symptom scores, peak flow rate and quality of life in men suffering from lower urinary tract symptoms (LUTS) secondary to Benign Prostatic Hypertrophy (BPH) following treatment with ozarelix. Ozarelix is compared to placebo and injections given 14 days apart. Patients are followed for 6 months and both safety and efficacy assessed at monthly visits. Additionally, the impact of treatment on erectile function, if any, as well as Prostate-Specific Antigen (PSA) and Testosterone levels will be monitored. The screening period of 7 days. The duration of the study is 40 weeks, including a 28-day placebo run-in phase (eligible participants entered a placebo run-in phase in which placebo is administered twice over a 2 week period [Day -28 and Day -14] and participants are assessed to establish baseline values approximately 14 days following the second placebo injection), study drug is administered on Days 0 and 14 followed by 34 weeks of observation after the last dose of study drug. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00427219
Study type Interventional
Source Spectrum Pharmaceuticals, Inc
Contact
Status Completed
Phase Phase 2
Start date January 23, 2007
Completion date February 27, 2008

See also
  Status Clinical Trial Phase
Completed NCT02509975 - Safety and Efficacy of OCL 503 in Prostate Artery Embolization N/A
Completed NCT01177436 - Prostate Cancer Antigen 3 (PCA-3) Gene Project N/A
Completed NCT05082142 - Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP) Phase 4
Completed NCT01260129 - Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH Phase 4
Completed NCT00771394 - Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia Phase 4
Active, not recruiting NCT03630926 - Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.
Completed NCT02429219 - Saline With Alcohol in TransUrethral Resection aNd Photoselective Vaporisation of the Prostate N/A
Completed NCT01342562 - The Effects of Intrathecal Dexmedetomidine on Spinal Anesthesia Using Diluted Low-Dose Bupivacaine for Transurethral Resection of Prostate in Elderly N/A
Completed NCT00382356 - Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H) N/A
Completed NCT00029822 - Clinical Trial in Males With BPH (Enlarged Prostate) Phase 3
Completed NCT05308017 - Wolf 24 F vs. Storz 28 F Laser Sheath Size for HoLEP N/A
Completed NCT00670306 - Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH) Phase 3
Completed NCT00663858 - Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH) Phase 3
Terminated NCT00449150 - Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH) Phase 3
Completed NCT00037141 - Safety/Tolerability Study of Alcohol Injection for Treatment of BPH (Enlarged Prostate) Phase 1/Phase 2
Suspended NCT02533687 - Comparison of Different Energy Sources During TUR-P N/A
Completed NCT04781049 - Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial N/A
Completed NCT02051036 - Moxibustion as an Adjuvant for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms: a Pilot Study N/A
Completed NCT00634608 - Integrating Targeted MedlinePlus Health Prescriptions Into Clinic Practice Workflow N/A
Completed NCT02401581 - Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours N/A