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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 26, 2004 | ||||
| Last Updated Date | January 24, 2008 | ||||
| Start Date ICMJE | December 2003 | ||||
| Primary Completion Date | November 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00076531 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Trial for Prostate Cancer | ||||
| Official Title ICMJE | |||||
| Brief Summary | Phase III trial using an injectable for treatment of prostate cancer. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Safety/Efficacy Study | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Drug: Leuprolide Acetate for Injectable Suspension 22.5 mg | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | November 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | |||||
| Gender | Male | ||||
| Ages | 40 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00076531 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | OL-007 | ||||
| Study Sponsor ICMJE | Oakwood Laboratories, LLC | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Oakwood Laboratories, LLC | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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