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

• Status: Completed
• Trial end date: 2008-02-27
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

• All of the following questions must be answered "Yes" at Visit 1 in order for the participant to participate in the study.

• Is the participant at least 50 years old?

• Does the participant have clinical signs and symptoms consistent with BPH?

• Does the participant have an IPSS 13 at screening (prior to placebo run in)?

• Does the participant have a peak urinary flow rate (Qmax) of 4-15 milliliter/second (mL/sec) established on a voided volume of at least 125 mL?

• Is the participant willing to agree not to use any other approved or experimental pharmacologic BPH treatments including alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during the study?

Exclusion Criteria: All of the following questions must be answered "No" at Visit 1 in order for the participant to participate in the study.

• Does the participant have a history of prostate cancer or a serum PSA >10 nanograms per milliliter (ng/mL)?

• Has the participant had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy?

• Does the participant have a prevoid total bladder volume assessed by ultrasound > 550 mL?

• Does the participant have a residual urine volume > 350 mL by ultrasound?