A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
Summary
The purpose of this study is to determine if new formulations (11.25 and 30 mg) of leuprolide are effective in treating children with Central Precocious Puberty.
Description
Study Design:
Approximately 80 children with confirmed Central Precocious Puberty will be randomized in a 1:1 ratio to receive a total of two (2) injections of either leuprolide acetate 11.25 mg or 30 mg depot formulation, each injection administered 3 months apart (6 months of treatment):
This study includes a Screening Period (up to 4 weeks), two 3-month treatment cycles, and a posttreatment follow-up period (12 weeks following the Month 6 visit). Study visits will occur at Screening, Day 1, Week 2 (only for subjects participating in the PK subset), Months 1, 2, 3, Month 6/Early Termination, and 12 weeks later, for the Posttreatment Follow-up Visit.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Puberty, Precocious
Intervention
Leuprolide acetate 11.25 mg, Leuprolide acetate 30 mg
Location
Birmingham
Alabama
United States
35233
Status
Completed
Source
Abbott
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00635817
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Acetylesterase
An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 3.1.1.6.
Megestrol Acetate
Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
Melengestrol Acetate
A 6-methyl PROGESTERONE acetate with reported glucocorticoid activity and effect on ESTRUS.
Acetate-coa Ligase
An enzyme that catalyzes the formation of CoA derivatives from ATP, acetate, and CoA to form AMP, pyrophosphate, and acetyl CoA. It acts also on propionates and acrylates. EC 6.2.1.1.
Acetate Kinase
An enzyme that catalyzes reversibly the phosphorylation of acetate in the presence of a divalent cation and ATP with the formation of acetylphosphate and ADP. It is important in the glycolysis process. EC 2.7.2.1.
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