Offered by: Nemours Children's Specialty Care, Jacksonville
Location: Jacksonville, Fla.
Study on Safety of Injectable Leuprolide Acetate in Subjects With Central Precocious Puberty
What is the trial about?
The purpose of this study is to determine the safety and effectiveness of a medicine called Leuprolide acetate 45 mg for the treatment of children with Central Precocious Puberty (CPP), a condition that causes children to show signs of puberty early.
Who can participate?
Children with precocious puberty from 2 to 8 (girls) or 2 to 9 (boys) years old will be in this study.
What is involved?
The study visits, including screening, will take place at Nemours Children’s Health System in Jacksonville. The baseline visit will be done at Wolfson Children’s Hospital. This study includes a Screening Period (up to 4 weeks) and a Study Drug Period (up to a total of approximately 24 months). After your screening, your next visit is Visit 1 (also called baseline). At that time a numbing cream will be placed on a hand or arm vein to numb the skin, and a small needle placed in the vein to draw blood from. Blood samples will be collected at four time points before and after a dose of the medicine long acting leuprolide acetate 45 mg suspension is given using a needle (injection) under the skin (30 minutes before the injection and 1 hour, 4 hours and 6 hours after the injection). All the blood will be drawn through the vein.
The study will take ~6 mL (about 1 teaspoon) of blood and collect urine for laboratory tests for general health and levels of hormones in the body that tell us about the stage of puberty. At all study visits, a small amount of blood (2.5 mL or about a half teaspoon) will also be taken to look at the amount of the study drug in the body.
An X-ray of the left hand and wrist will be done to determine bone age. This will happen only 5 times during the study .
Contact Nemours Clinical Trials
Trial Name: Study on Safety of Leuprolide treatment in Subjects With CPP