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Histrelin Subcutaneous Implant in Children With Central Precocious Puberty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00779103
First received: October 22, 2008
Last updated: July 12, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to follow and collect additional medical and developmental information on children after histrelin subcutaneous implant therapy is discontinued.


Condition Intervention Phase
Central Precocious Puberty
 Drug: Histrelin Subcutaneous Implant
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Puberty
U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • LH suppression following stimulation with a GnRH analog (leuprolide acetate) [ Time Frame: Every 6 months until hormone suppression is discontinued ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Collect long term medical and developmental information until adulthood [ Time Frame: Up to 8-10 years post treatment ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2004
Estimated Study Completion Date: December 2015
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Histrelin Subcutaneous Implant
    histrelin subcutaneous 50 mg implant
    Other Names:
    • Supprelin LA
    • implant therapy
    • histrelin implant
  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sr Director Clinical R & D, Endo Pharmaceuticals Solutions Inc.
ClinicalTrials.gov Identifier: NCT00779103     History of Changes
Other Study ID Numbers: EN3326-300Former03-CPP-HIS-300
Study First Received: October 22, 2008
Last Updated: July 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
puberty
precocious puberty
early puberty
early onset puberty
 histrelin
histrelin subcutaneous implant
implant therapy

Additional relevant MeSH terms:
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 13, 2013