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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
Phase 2 trial testing Ozarelix in Benign Prostatic Hypertrophy in 74 participants. Completed in 27 February 2008.
27 February 2008
Quick facts
| Lead sponsor | Spectrum Pharmaceuticals, Inc |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 74 |
| Start date | 23 January 2007 |
| Primary completion | 27 February 2008 |
| Estimated completion | 27 February 2008 |
| Sites | 13 locations across United States |
Drugs / interventions tested
- Ozarelix — full drug profile →
- Placebo
Conditions studied
- Benign Prostatic Hypertrophy — all drugs for Benign Prostatic Hypertrophy →
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.
Verify or expand the search:
- PubMed search for NCT00427219
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Spectrum Pharmaceuticals, Inc trials
Trials by the same sponsor.
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- NCT04981704 — A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacok · Phase 1 · completed
- NCT04402008 — Study of Poziotinib in Japanese Patients With NSCLC · Phase 1, PHASE2 · terminated
- NCT04436562 — Study of the Absorption, Metabolism, and Excretion Following a Single Dose of [14C]-Poziotinib in Healthy Male Subjects · Phase 1 · completed
- NCT04187898 — Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00427219 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Spectrum Pharmaceuticals, Inc
- Last refreshed: 15 October 2021
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