The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate
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)
1 other identifier
interventional
74
1 country
13
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 Benign Prostatic Hypertrophy (BPH) who are over 50 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2007
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 23, 2007
CompletedFirst Submitted
Initial submission to the registry
January 24, 2007
CompletedFirst Posted
Study publicly available on registry
January 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2008
CompletedOctober 15, 2021
October 1, 2021
1.1 years
January 24, 2007
October 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in International Prostate Symptom Score (IPSS)
IPSS is a validated self-administered index for grading benign prostatic hyperplasia (BPH)-related signs and symptoms. It consists of a set of seven questions. A total score of 1-7 indicates mild disease, 8-19 moderate disease and 20-35 severe disease.
12 weeks
Secondary Outcomes (6)
International Prostate Symptom Score - Quality of Life (IPSS-QOL)
36 weeks
BPH Impact Index (BPHII)
36 weeks
Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)
36 weeks
International Index of Erectile Function-15 (IIEF-15)
36 weeks
Maximum Urinary Flow Rate (Qmax)
36 weeks
- +1 more secondary outcomes
Study Arms (2)
Ozarelix
EXPERIMENTALAll participants completing the placebo run in period were randomized to enter the treatment phase of the study and received ozarelix on Day 0 and Day 14.
Placebo
PLACEBO COMPARATORAll participants completing the placebo run in period were randomized to enter the treatment phase of the study and received placebo Day 0 and Day 14.
Interventions
Eligibility Criteria
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?
You may not qualify if:
- 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?
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Donald Gleason, MD
Tucson, Arizona, 85712, United States
Jay Young, MD
Laguna Hills, California, 92653, United States
Alexander Gershman, MD
Los Angeles, California, 90048, United States
Stephen Auerbach, MD
Newport Beach, California, 92660, United States
Eugene Dula, MD
Tarzana, California, 91356, United States
Joel Kaufman, MD
Aurora, Colorado, 80012, United States
Ira Klimberg, MD
Ocala, Florida, 34474, United States
Joseph Williams, MD
Meridian, Idaho, 83642, United States
Christopher Steidle, MD
Fort Wayne, Indiana, 46825, United States
Steven Bigg, MD
St Louis, Missouri, 63136, United States
Jed Kaminetsky, MD
New York, New York, 10016, United States
William Fitch, MD
San Antonio, Texas, 78229, United States
Gregg Eure, MD
Virginia Beach, Virginia, 23454, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2007
First Posted
January 26, 2007
Study Start
January 23, 2007
Primary Completion
February 27, 2008
Study Completion
February 27, 2008
Last Updated
October 15, 2021
Record last verified: 2021-10