A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty

03:43 EST 20th December 2014 | BioPortfolio

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)

View Results

Links

Clinical Trials [434 Associated Clinical Trials listed on BioPortfolio]

Study of Lupron Depot In The Treatment of Central Precocious Puberty

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...

Safety Extension Study Of Lupron Depot In The Treatment Of Central Precocious Puberty

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).

Neoadjuvant Abiraterone Acetate Plus Leuprolide Acetate in Men With Localized High Risk Prostate Cancer

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 ...

Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer

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...

Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy

Primary Objective : - The primary objective of the study is to compare progression-free survival (PSA progression after systemic treatment, radiologically or histologically docume...

PubMed Articles [927 Associated PubMed Articles listed on BioPortfolio]

Title: 36-Month Treatment Experience of 2 Doses of Leuprolide Acetate 3-Month Depot for Children With Central Precocious Puberty.

Context: We have recently demonstrated short-term (6 months) efficacy and safety of leuprolide acetate 3-month depot 11.25 and 30 mg in children with central precocious puberty (CPP). Objective: To as...

Leuprolide Acetate-Induced Generalized Papular Eruption.

Leuprolide acetate, a gonadotropin-releasing hormone agonist, is used in the treatment of prostate cancer. We report a unique case of a disseminated papular rash following leuprolide acetate injection...

The Usefulness of the Leuprolide Stimulation Test as a Diagnostic Method of Idiopathic Central Precocious Puberty in Girls.

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...

In vivo evaluation of an oral self-microemulsifying drug delivery system (SMEDDS) for leuprorelin.

The objective of this study was to develop a self-microemulsifying drug delivery system (SMEDDS) for the model peptide drug leuprorelin to prove a protective effect against luminal enzymatic metabolis...

Adult height following a combined treatment of ketoconazole - cyproterone acetate - leuprolide depot in a boy with atypical McCune-Albright syndrome.

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...

Medical and Biotech [MESH] Definitions

An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 3.1.1.6.

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 6.2.1.1.

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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