Status:
COMPLETED
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Central Precocious Puberty
Eligibility:
All Genders
2-10 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to follow and collect additional medical and developmental information on children after histrelin subcutaneous implant therapy is discontinued.
Detailed Description
Thirty-two (32) patients will receive a histrelin subdermal implant under the anesthesia deemed appropriate by the administering physician. Ten-twelve (10-12) sites will enroll 2-3 patients per site. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00779103
Start Date
September 1 2004
End Date
April 1 2012
Last Update
January 8 2021
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