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Pharmacokinetic Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

2016-06-23 19:08:22 | BioPortfolio

Summary

Exploring the efficacy in Leuprolide 45mg in slowing down or reversing Central Precocious Puberty in girls ages 2-8 and boys ages 2-9.

Description

Primary Objectives Determine the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with CPP.

Secondary Objectives

- Evaluate the safety and tolerability of leuprolide acetate 45 mg for injectable suspension in children with CPP

- Characterize the burst kinetics of leuprolide acetate 45 mg after the first administration

- Characterize the pharmacodynamic (PD) relationship of leuprolide serum concentrations to concentrations of serum LH, FSH and to testosterone/estradiol

- Assess percent changes in height velocity and bone age progression after the first administration

- Assess changes in physical signs of puberty as measured by changes in Tanner stages or in changes or onset of menses

- Determine the dosing interval (5 or 6 months) at which leuprolide acetate is able to suppress LH concentration to <4 mIU/mL (after GnRHa stimulation test), as data permit

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Central Precocious Puberty

Intervention

Leuprolide

Location

Nemours Children's Hospital
Orlando
Florida
United States
32827

Status

Recruiting

Source

Nemours Children's Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-23T19:08:22-0400

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PubMed Articles [4280 Associated PubMed Articles listed on BioPortfolio]

LHCGR Gene Analysis in Girls with Non-Classic Central Precocious Puberty.

Luteinizing hormone (LH) is a useful parameter in diagnosing precocious puberty. The pubertal response of serum LH to a GnRH stimulation test is varied, and clinical symptoms of precocious puberty are...

Insulin resistance and bone age advancement in girls with central precocious puberty.

Precocious puberty has significantly increased recently. While obesity is associated with puberty timing, the relationship between obesity and central precocious puberty (CPP) remains controversial. T...

There is no association between vitamin D status and characteristics of central precocious puberty in girls.

Vitamin D deficiency has been associated with several pathologies in humans and has recently been linked to idiopathic central precocious puberty in girls. We evaluated this potential link in a retros...

Kisspeptin permits the sexual development of female rats with normal and precocious puberty but is not a trigger for it.

We inferred how KISS-1/GPR54 system to involved in precocious puberty by observing hormones level during the process of precocious puberty in model and normal rats during sexual development and the es...

One-Year Follow-Up of Girls with Precocious Puberty and Their Mothers: Do Psychological Assessments Change over Time or with Treatment?

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Medical and Biotech [MESH] Definitions

A potent synthetic agonist of GONADOTROPIN-RELEASING HORMONE with 3-(2-naphthyl)-D-alanine substitution at residue 6. Nafarelin has been used in the treatments of central PRECOCIOUS PUBERTY and ENDOMETRIOSIS.

Development of SEXUAL MATURATION in boys and girls at a chronological age that is 2.5 standard deviations below the mean age at onset of PUBERTY in the population. This early maturation of the hypothalamic-pituitary-gonadal axis results in sexual precocity, elevated serum levels of GONADOTROPINS and GONADAL STEROID HORMONES such as ESTRADIOL and TESTOSTERONE.

The lack of development of SEXUAL MATURATION in boys and girls at a chronological age that is 2.5 standard deviations above the mean age at onset of PUBERTY in a population. Delayed puberty can be classified by defects in the hypothalamic LHRH pulse generator, the PITUITARY GLAND, or the GONADS. These patients will undergo spontaneous but delayed puberty whereas patients with SEXUAL INFANTILISM will not.

A neoplasm composed entirely of GRANULOSA CELLS, occurring mostly in the OVARY. In the adult form, it may contain some THECA CELLS. This tumor often produces ESTRADIOL and INHIBIN. The excess estrogen exposure can lead to other malignancies in women and PRECOCIOUS PUBERTY in girls. In rare cases, granulosa cell tumors have been identified in the TESTES.

Benign and malignant tumors of the HYPOTHALAMUS. Pilocytic astrocytomas and hamartomas are relatively frequent histologic types. Neoplasms of the hypothalamus frequently originate from adjacent structures, including the OPTIC CHIASM, optic nerve (see OPTIC NERVE NEOPLASMS), and pituitary gland (see PITUITARY NEOPLASMS). Relatively frequent clinical manifestations include visual loss, developmental delay, macrocephaly, and precocious puberty. (From Devita et al., Cancer: Principles and Practice of Oncology, 5th ed, p2051)

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