Summary

for people ages 2-9 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

Official Title

An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty

Details

Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the progression of puberty.

Keywords

Precocious Puberty, Central Puberty, Precocious Leuprolide Leuprolide Acetate 45 mg

Eligibility

You can join if…

Open to people ages 2-9

  • Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive)
  • Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
  • Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation
  • Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males
  • Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year

You CAN'T join if...

  • Gonadotropin-independent (peripheral) precocious puberty
  • Prior or current GnRH treatment for CPP
  • Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1)
  • Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height for age)
  • Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
  • Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study

Locations

  • University of California, San Diego
    San Diego California 92123 United States
  • Instituto de Investigaciones Aplicadas a la Neurociencia, A.C.
    Durango 34000 Mexico
  • MultiCare Institute for Research and Innovation
    Tacoma Washington 98405 United States
  • Seattle Children's
    Seattle Washington 98105 United States
  • Hospital Unversitario "Dr. Jose Eleuterio Gonzalez"
    Monterrey Nuevo Leon 64460 Mexico
  • University of Oklahoma College of Medicine
    Tulsa Oklahoma 74135 United States
  • University of Calgary, Alberta Children's Hospital
    Calgary Alberta T3B 6A8 Canada

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tolmar Inc.
ID
NCT02452931
Phase
Phase 3
Study Type
Interventional
Last Updated
March 5, 2018