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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 [4338 Associated PubMed Articles listed on BioPortfolio]

Predictors of bone maturation, growth rate and adult height in children with central precocious puberty treated with depot leuprolide acetate.

Children with central precocious puberty (CPP) are treated with gonadotropin-releasing hormone agonists (GnRHa) to suppress puberty. Optimizing treatment outcomes continues to be studied. The relation...

Central precocious puberty in Boston boys: A 10-year single center experience.

Recent studies in the US and abroad suggest that boys are undergoing puberty at a younger age. It is unknown if this secular trend extends to boys with central precocious puberty (CPP), who sit at the...

Serum inhibin B concentration as a predictor of age at first menstruation in girls with idiopathic central precocious puberty.

To compare the serum inhibin B, anti-Müllerian hormone (AMH) and leptin concentrations in girls with idiopathic central precocious puberty (CPP) to their concomitant characteristics and evaluate the ...

Prevalence of cranial MRI findings in girls with central precocious puberty: a systematic review and meta-analysis.

Some pediatric endocrinologists recommend that girls with central precocious puberty (CPP) have cranial magnetic resonance imaging (MRI) performed only if they are younger than 6 years of age. However...

Resistin levels are not associated with obesity in central precocious puberty.

To compare serum resistin concentrations between prepubertal girls with a BMI > 85th percentile and girls with precocious puberty (CPP) who have and have not undergone GnRH analog treatment.

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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