Safety Extension Study Of Lupron Depot In The Treatment Of Central Precocious Puberty
Tracking Information | |||||
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First Received Date ICMJE | April 24, 2008 | ||||
Last Updated Date | August 11, 2012 | ||||
Start Date ICMJE | December 2008 | ||||
Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Suppression of peak-stimulated luteinizing hormone concentrations (< 4 mIU/mL). [ Time Frame: Day 1, Months 6, 12, 24, and 36 ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
Suppression of luteinizing hormone concentrations (<4 mIU/mL). [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: Yes ] | ||||
Change History | Complete list of historical versions of study NCT00667446 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety Extension Study Of Lupron Depot In The Treatment Of Central Precocious Puberty | ||||
Official Title ICMJE | A 36 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children With Central Precocious Puberty | ||||
Brief Summary | The purpose of this study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months). |
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Detailed Description | Approximately 70 subjects with Central Precocious Puberty from approximately 25 sites who completed the treatment period of the lead-in study, L-CP07-167, will enter this 36 month open-label extension study. This study includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit). Subjects will receive a total of twelve (12) injections of the same treatment they received in the lead-in study, either leuprolide acetate 11.25 mg or 30 mg depot formulation. Each injection will be administered 3 months apart for up to 36 months of treatment. Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Puberty, Precocious | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 70 | ||||
Estimated Completion Date | January 2013 | ||||
Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Gender | Both | ||||
Ages | 2 Years to 12 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Puerto Rico | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00667446 | ||||
Other Study ID Numbers ICMJE | L-CP07-177 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Abbott | ||||
Study Sponsor ICMJE | Abbott | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Abbott | ||||
Verification Date | July 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |