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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 17, 2005 | ||||
| Last Updated Date | October 19, 2005 | ||||
| Start Date ICMJE | April 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00220194 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer | ||||
| Official Title ICMJE | A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer | ||||
| Brief Summary | Comparing the effect of switching from Lupron and Zoladex to Eligard. PSA and Testosterone levels are measured at set intervals to determine if Eligard is equal or better then Lupron or Zoladex in advanced Prostate Cancer patients. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study | ||||
| Condition ICMJE | Cancer of Prostate | ||||
| Intervention ICMJE | Drug: leuprolide acetate | ||||
| 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 | 100 | ||||
| Completion Date | June 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patient with Advanced Ca, on stable dose of Lupron or Zoladex - Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00220194 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | SBU001, Sanofi Aventis | ||||
| Study Sponsor ICMJE | San Bernardino Urological Associates Medical Group Inc | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | San Bernardino Urological Associates Medical Group Inc | ||||
| Verification Date | September 2005 | ||||
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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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