Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01634321 |
Date of registration:
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03/07/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty
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Scientific title:
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The Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty; A Single, Open, Multi-center, Prospective Study |
Date of first enrolment:
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July 2011 |
Target sample size:
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63 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01634321 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 4~8 years & tanner stage = 2
Exclusion Criteria:
- Previous treatment with GnRH analog therapy
Age minimum:
4 Years
Age maximum:
9 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Central Precocious Puberty
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Intervention(s)
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Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg)
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Primary Outcome(s)
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At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations
[Time Frame: At 24 weeks]
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Secondary ID(s)
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DW_LP1M002P
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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