A 36 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children With Central Precocious Puberty

NCT00667446 Phase 3 COMPLETED Results posted

The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).

Details

Lead sponsor	AbbVie (prior sponsor, Abbott)
Phase	Phase 3
Status	COMPLETED
Enrolment	72
Start date	2008-12
Completion	2013-01

Conditions

• Precocious
• Leuprolide Acetate
• Luteinizing Hormone (LH)
• Gonadotrophin-releasing Hormone Agonist (GnRHa)
• Tanner Staging
• Depot Formulation
• Suppression of LH
• Central Precocious Puberty (CPP)
• Gonadotrophin-releasing Hormone (GnRH)
• Lupron

Interventions

• Leuprolide Acetate 3 Month Depot

Primary outcomes

• Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone — Day 1, Months 6, 12, 24, and 36
  Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \< 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.

Countries

United States, Puerto Rico