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

Completed · Phase 3

Conditions studied: Precocious Puberty, Central

In brief

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

Key facts

Study ID

NCT02452931

Run by

Tolmar Inc.

People needed

64

Starts

2015-08-31

Expected to finish

2018-09-05

Last updated by the study team

2020-06-02

Who can join

Age: 2 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• University of California, San Diego — San Diego, California, United States
• Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Cincinnati Children's Hospital Medical Center, Endocrine — Cincinnati, Ohio, United States
• University of Oklahoma College of Medicine — Tulsa, Oklahoma, United States
• Seattle Children's — Seattle, Washington, United States
• MultiCare Institute for Research and Innovation — Tacoma, Washington, United States
• Hospital de Ninos — Buenos Aires, Argentina
• University of Calgary, Alberta Children's Hospital — Calgary, Alberta, Canada
• McGill University Health Centre — Montreal, Quebec, Canada
• CHU de Quebec-Universite Laval — Québec, Canada
• Pontificia Universidad Catolica de Chile — Santiago, Santiago Metropolitan, Chile
• Instituto de Investigaciones Materno Infantil (IDIMI) — Santiago, Santiago Metropolitan, Chile
• Hospital Regional de Antofagasta Leonardo Guzman — Antofagasta, Second Region, Chile
• Hospital Unversitario "Dr. Jose Eleuterio Gonzalez" — Monterrey, Nuevo León, Mexico
• Instituto de Investigaciones Aplicadas a la Neurociencia, A.C. — Durango, Mexico
• The Liggins Institute, University of Auckland — Auckland, New Zealand

Full record on ClinicalTrials.gov

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