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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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)

Brief Summary: This study will compare the efficacy and safety of ozarelix 15 mg. given IM 2 weeks apart on the improvement of symptoms and the duration of improvement for up to 6 months in men with BPH who are over 50 years of age.

Detailed Summary: This study will compare the improvement in symptom scores, peak flow rate and quality of life in men suffering from LUTS secondary to BPH following treatment with ozarelix. Ozarelix will be compared to placebo and injections will be given 14 days apart. Patients will be followed for 6 months and both safety and efficacy will be assessed at monthly visits.Additionally the impact of treatment on erectile function, if any, as well as PSA and Testosterone levels will be monitored.
Sponsor: Spectrum Pharmaceuticals, Inc

Current Primary Outcome: Improvement in IPSS compared to placebo [ Time Frame: 12 weeks ]

Original Primary Outcome: Improvement in IPSS compared to placebo

Current Secondary Outcome: IPSS subscores; IPSS QOL ;BII;LUTS GAQ;Qmax;To examine the effect of ozarelix on erectile function in sexually active men;To assess the safety and tolerability of ozarelix [ Time Frame: 36 weeks ]

Original Secondary Outcome: IPSS subscores; IPSS QOL ;BII;LUTS GAQ;Qmax;To examine the effect of ozarelix on erectile function in sexually active men;To assess the safety and tolerability of ozarelix

Information By: Spectrum Pharmaceuticals, Inc

Dates:
Date Received: January 24, 2007
Date Started: January 2007
Date Completion:
Last Updated: June 6, 2012
Last Verified: June 2012