NCT00427219

The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate

A 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 Hypertrophy (BPH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Benign Prostatic Hypertrophy

Interventions

Type	Name	Description
DRUG	Ozarelix	Ozarelix 15 mg will be administered IM on Day 0 and Day 14.
DRUG	Placebo	Placebo will be administered IM on Day 0 and Day 14.

Timeline

• Start date: 2007-01-23
• Primary completion: 2008-02-27
• Completion: 2008-02-27
• First posted: 2007-01-26
• Last updated: 2021-10-15

Locations

13 sites across 1 country: United States