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

Completed · Phase 2 · Has a placebo group

Conditions studied: Benign Prostatic Hypertrophy

In brief

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.

Key facts

Study ID

NCT00427219

Run by

Spectrum Pharmaceuticals, Inc

People needed

74

Starts

2007-01-23

Expected to finish

2008-02-27

Last updated by the study team

2021-10-15

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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?

Where it is running

• Donald Gleason, MD — Tucson, Arizona, United States
• Jay Young, MD — Laguna Hills, California, United States
• Alexander Gershman, MD — Los Angeles, California, United States
• Stephen Auerbach, MD — Newport Beach, California, United States
• Eugene Dula, MD — Tarzana, California, United States
• Joel Kaufman, MD — Aurora, Colorado, United States
• Ira Klimberg, MD — Ocala, Florida, United States
• Joseph Williams, MD — Meridian, Idaho, United States
• Christopher Steidle, MD — Fort Wayne, Indiana, United States
• Steven Bigg, MD — St Louis, Missouri, United States
• Jed Kaminetsky, MD — New York, New York, United States
• William Fitch, MD — San Antonio, Texas, United States
• Gregg Eure, MD — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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