Status:
COMPLETED
Study of Lupron Depot In The Treatment of Central Precocious Puberty
Lead Sponsor:
Abbott
Conditions:
Puberty, Precocious
Eligibility:
All Genders
Up to 10 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide...
Detailed Description
This study includes a Prestudy Period; a treatment period where subjects will receive treatment every 4 weeks until the initiation of puberty (age 12 for males and age 11 for females); a follow-up per...
Eligibility Criteria
Inclusion
- Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II for pubic hair or genitalia earlier than 9.0 years in boys.
- Confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone (GnRH) stimulation test (LH \> 10 U/L at baseline).
- Chronological age less than 9.0 years in girls or less than 10.0 years in boys at time of first dosing.
- Bone age advanced at least 1 year beyond the chronological age at entry into the study.
- The condition may be idiopathic or secondary to another lesion. If secondary, therapy of the primary condition will have been undertaken and stabilized.
- No evidence of abnormal pituitary, adrenal, thyroid and gonadal function except for premature secretion of gonadotropins.
Exclusion
- Irradiation to the central nervous system.
- Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).
Key Trial Info
Start Date :
January 1 1991
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00660010
Start Date
January 1 1991
End Date
April 1 2009
Last Update
April 12 2011
Active Locations (9)
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1
Site Reference ID/Investigator# 46673
Phoenix, Arizona, United States, 85006
2
Site Reference ID/Investigator# 46671
San Francisco, California, United States, 94122
3
Site Reference ID/Investigator# 14921
Stanford, California, United States, 94305
4
Site Reference ID/Investigator# 14343
Aurora, Colorado, United States, 80045