A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
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.
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.
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Leuprolide acetate 11.25 mg, Leuprolide acetate 30 mg
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00635817
- Information obtained from ClinicalTrials.gov on July 15, 2010
The purpose of this study is to determine if leuprolide acetate is safe and effective in treating children with Central Precocious Puberty, and to assess long term effects of leuprolide ac...
The purpose of this 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 (12 months).
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This randomized phase I/II trial studies giving leuprolide acetate or goserelin acetate together with or without vismodegib followed by surgery to see how well they work in treating patien...
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Central precocious puberty (CPP) diagnosis is based on clinical evaluation, but hormonal evaluation is crucial. The aim of the study was to evaluate the usefulness of the leuprolide stimulation test f...
This study was carried out because of the rarity of peripheral precocious puberty (PPP) in boys with McCune-Albright syndrome (MAS) and the lack of data on adult height of treated MAS males, treatment...
To evaluate the efficacy of gonadotropin-releasing hormone analogue (GnRHa) use before laparoscopic myomectomy (LM) in large myomas.
To study expressions of netrin-1 and its receptor UNC5C in female precocious puberty rat hypothalamus, and explore its effect on precocious puberty process.
Considering the role of kisspeptin (KISS) in the process of puberty, this study aimed to determine the mutation of KISS1 gene among a group of patients with idiopathic central precocious puberty (ICPP...
Medical and Biotech [MESH] Definitions
An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 18.104.22.168.
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)
A 6-methyl PROGESTERONE acetate with reported glucocorticoid activity and effect on ESTRUS.
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 22.214.171.124.
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 126.96.36.199.