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NCT00427219 · ClinicalTrials.gov registry record · Phase 2
The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate
A Phase 2 study of Benign Prostatic Hypertrophy, sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
- 13
- Study locations
NCT00427219: Completed Phase 2 study of Benign Prostatic Hypertrophy, sponsored by Spectrum Pharmaceuticals.
NCT00427219 is a Phase 2 study of Benign Prostatic Hypertrophy that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 74 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00427219, a Phase 2 study of Benign Prostatic Hypertrophy, has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
- 13
- Study locations
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.
Primary Outcome
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.
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 |
What the finished NCT00427219 record still lists
NCT00427219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
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.
NCT00427219 lists 13 locations in 10 states (California, Arizona, Colorado).
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.
What interventions are being tested in trial NCT00427219?
The interventions under investigation include: Placebo (DRUG), Ozarelix (DRUG).
Who is sponsoring clinical trial NCT00427219?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
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
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Where NCT00427219's enrollment target sits among peer trials
74 920th of 2000 higher than 1,077 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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