NCT00743184

Trial of the Safety and Efficacy of Ozarelix in Participants With Benign Prostatic Hyperplasia (BPH)

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Benign Prostatic Hyperplasia (BPH)
• Lower Urinary Tract Symptoms (LUTS)

Interventions

Type	Name	Description
DRUG	ozarelix	One single-dose vial contains 16.5 mg of ozarelix. The drug is reconstituted with 1.3 mL of diluent.
DRUG	Placebo	Identical placebo is also provided and reconstituted using diluent containing 0.1% saline solution.

Timeline

• Start date: 2008-12-04
• Primary completion: 2010-01-20
• Completion: 2010-01-20
• First posted: 2008-08-28
• Last updated: 2021-11-22

Locations

1 site across 1 country: United States