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

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

 -  Is the patient at least 50 years old?

 -  Does the patient have clinical signs and symptoms consistent with BPH?

 -  Does the patient have an IPSS ³13 at screening (prior to placebo run in)?

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

 -  Is the patient 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 patient to participate in the study.

 -  Does the patient have a history of prostate cancer or a serum PSA >10 ng/mL?

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

 -  Does the patient have a prevoid total bladder volume assessed by ultrasound > 550 mL?

 -  Does the patient have a residual urine volume > 350 mL by ultrasound?

 -  Has the patient taken or is currently taking any of the following: