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NCT00427219

The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate

Completed Phase 2 Last updated 15 October 2021
What this trial tests

Phase 2 trial testing Ozarelix in Benign Prostatic Hypertrophy in 74 participants. Completed in 27 February 2008.

Timeline
23 January 2007
Primary endpoint
27 February 2008
27 February 2008

Quick facts

Lead sponsorSpectrum Pharmaceuticals, Inc
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment74
Start date23 January 2007
Primary completion27 February 2008
Estimated completion27 February 2008
Sites13 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Spectrum Pharmaceuticals, Inc — full company profile →

Who can join

50 and older, male only, with Benign Prostatic Hypertrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Spectrum Pharmaceuticals, Inc trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00427219.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing