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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 is a Phase 2 study of Benign Prostatic Hypertrophy that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 74 participants. The trial reports 13 study locations across 10 states.

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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.

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

FieldValue
Enrollment Target 74 participants
Start Date 2007-01-23
Est. Completion 2008-02-27
Phase Phase 2

Sponsor

Spectrum Pharmaceuticals

52 total trials

What the Registry Record Tells You About NCT00427219

The ClinicalTrials.gov registry entry for NCT00427219 describes a study currently listed as completed, categorized as Phase 2. 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 52 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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