Status:
COMPLETED
The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Benign Prostatic Hypertrophy
Eligibility:
MALE
50+ years
Phase:
PHASE2
Brief 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 ...
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)...
Eligibility Criteria
Inclusion
- \- 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
- 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?
Key Trial Info
Start Date :
January 23 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2008
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00427219
Start Date
January 23 2007
End Date
February 27 2008
Last Update
October 15 2021
Active Locations (13)
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1
Donald Gleason, MD
Tucson, Arizona, United States, 85712
2
Jay Young, MD
Laguna Hills, California, United States, 92653
3
Alexander Gershman, MD
Los Angeles, California, United States, 90048
4
Stephen Auerbach, MD
Newport Beach, California, United States, 92660