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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 June 2015 |
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Main ID: |
NCT00779103 |
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Date of registration:
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22/10/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
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Scientific title:
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Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Children With Central Precocious Puberty |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00779103 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Contacts
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Name:
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Erica A Eugster, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indiana University School of Medicine, 705 Riley Hosp Dr, Rm 5960 Indianapolis, IN 46202 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pre-treated or treatment naive patients with gonadotropin-dependent precocious
puberty
- Pre-treatment pubertal type response of LH to a stndard GnRH stimulation test before
initiation of treatment
Exclusion Criteria:
- Children who are less than 2 years of age at enrollment
- Children whose chronological age is greater than 8 years (naive) and 10 years
(pre-treated) for girls or 9 years (naive) and 11 years (pre-treated) for boys at the
onset of the study
Age minimum:
2 Years
Age maximum:
10 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: Histrelin Subcutaneous Implant
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Primary Outcome(s)
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LH suppression following stimulation with a GnRH analog (leuprolide acetate)
[Time Frame: Every 6 months until hormone suppression is discontinued]
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Secondary Outcome(s)
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Collect long term medical and developmental information until adulthood
[Time Frame: Up to 8-10 years post treatment]
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Secondary ID(s)
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EN3326-300Former03-CPP-HIS-300
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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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