Study of Lupron Depot In The Treatment of Central Precocious Puberty

Completed · Phase 3

Conditions studied: Puberty, Precocious

In brief

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 acetate treatment after therapy is discontinued.

Key facts

Study ID

NCT00660010

Run by

Abbott

People needed

55

Starts

1991-01-01

Expected to finish

2009-04-01

Last updated by the study team

2011-04-12

Who can join

Age: any, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Site Reference ID/Investigator# 46673 — Phoenix, Arizona, United States
• Site Reference ID/Investigator# 46671 — San Francisco, California, United States
• Site Reference ID/Investigator# 14921 — Stanford, California, United States
• Site Reference ID/Investigator# 14343 — Aurora, Colorado, United States
• Site Reference ID/Investigator# 14341 — St. Petersburg, Florida, United States
• Site Reference ID/Investigator# 14342 — Indianapolis, Indiana, United States
• Site Reference ID/Investigator# 46672 — Baltimore, Maryland, United States
• Site Reference ID/Investigator# 46668 — Springfield, Massachusetts, United States
• Site Reference ID/Investigator# 14344 — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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