Histrelin Subcutaneous Implant in Children With Central Precocious Puberty

This study is ongoing, but not recruiting participants.

Sponsored by:	Indevus Pharmaceuticals
Information provided by:	Indevus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00779103

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 III

Drug Information available for: Histrelin Histrelin acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Indevus 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:

histrelin subcutaneous 50 mg 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

Responsible Party:	Indevus Pharmaceuticals ( Mark Roessel )
Study ID Numbers:	03-CPP-HIS-300
Study First Received:	October 22, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00779103
Health Authority:	United States: Food and Drug Administration

Keywords provided by Indevus Pharmaceuticals:

puberty
precocious puberty
early puberty
early onset puberty

histrelin
histrelin subcutaneous implant
implant therapy

Study placed in the following topic categories:

Gonadal Disorders
Puberty, Precocious
Precocious puberty
Endocrine System Diseases
Endocrinopathy

ClinicalTrials.gov processed this record on January 14, 2009