Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate
NCT00427219 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ozarelix
Study Locations (13)
California
- Jay Young, MD — Laguna Hills
- Alexander Gershman, MD — Los Angeles
- Stephen Auerbach, MD — Newport Beach
- Eugene Dula, MD — Tarzana
Arizona
- Donald Gleason, MD — Tucson
Colorado
- Joel Kaufman, MD — Aurora
Florida
- Ira Klimberg, MD — Ocala
Idaho
- Joseph Williams, MD — Meridian
Indiana
- Christopher Steidle, MD — Fort Wayne
Missouri
- Steven Bigg, MD — St Louis
New York
- Jed Kaminetsky, MD — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2007-01-23 |
| Est. Completion | 2008-02-27 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00427219
The ClinicalTrials.gov registry entry for NCT00427219 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spectrum Pharmaceuticals, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Benign Prostatic Hypertrophy appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00427219 reports 13 study locations spanning 10 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00427219 about?
NCT00427219 is a clinical study titled "The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate". 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.
What is the current status of trial NCT00427219?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2007-01-23. Estimated completion is 2008-02-27.
What conditions does trial NCT00427219 study?
This clinical trial studies the following conditions: Benign Prostatic Hypertrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00427219?
The interventions under investigation include: Placebo (DRUG), Ozarelix (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00427219?
This trial is sponsored by Spectrum Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00427219 being conducted?
This trial has 13 study locations across Arizona, California, Colorado, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.