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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
Published on BioPortfolio: 2014-07-24T14:18:28-0400
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).
Exploring the efficacy in Leuprolide 45mg in slowing down or reversing Central Precocious Puberty in girls ages 2-8 and boys ages 2-9.
The purpose of this research study is to determine the effects of abiraterone acetate plus leuprolide acetate and prednisone versus leuprolide acetate alone on hormone levels in the blood ...
This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide evaluation of the PK/PD metrics of two different oral doses selected upon the results of the stud...
Endometriosis affects over 10 million women in the United States. Depot leuprolide acetate (LA), a gonadotropin-releasing hormone agonist, has been used extensively for the treatment of women with end...
To evaluate the efficacy and safety of a triptorelin pamoate (11.25 mg) 3-month formulation in the management of central precocious puberty (CPP) (TP Study) and to retrospectively compare it with a tr...
The present study was carried out to find out the effect of leuprolide, a gonadotropin-releasing hormone (GnRH) receptor agonist, on l-arginine induced immunosuppression, and relates with brain and th...
trans-Epithelial delivery of medication across the vagina has proven successful for administration of small, lipophilic molecules such as sex steroids. However, little information is available regardi...
The use of gonadotropin-releasing hormone analogs has been reported in the treatment of gelastic seizures and precocious puberty associated with hypothalamic hamartomas, but not in other seizure types...
An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 188.8.131.52.
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 184.108.40.206.
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 220.127.116.11.
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...