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 GnRH Analog Pediatrics Central Precocious Puberty
Keywords: GnRH analog Luteinizing hormone (LH) Gonadotrophin-releasing hormone agonist(GnRHa) Suppression of LH Gonadotrophin-releasing hormone (GnRH) CPP Leuprolide acetate Central Precocious Puberty Depot formulation Lupron Tanner staging Pediatrics
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 72
Healthy volunteers: no

Brief summary:
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).

Detailed description:
This study includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit). Participants will receive a total of twelve injections of the same treatment they received in the lead-in study, L-CP07-167 (NCT00635817) either leuprolide acetate 11.25 mg or 30 mg depot formulation. Each injection will be administered 3 months apart for up to 36 months of treatment. Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit.

Arms:
arm 1: Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months (3M) apart. arm 2: Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.

Interventions: intervention 1: Leuprolide Acetate 3 Month Depot
Intervention descriptions: intervention 1: None

Protocol document: