Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)

Trial Name

Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)

What is the trial about?

The purpose of this study is to determine the safety and effectiveness of a long acting medicine called leuprolide acetate (LA) 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?

About 40 boys and girls with precocious puberty, ages 2-11, will be in this study from 20 research centers in the United States and Puerto Rico. Up to 10 children will be enrolled at Nemours Health System in Jacksonville.

What is involved?

The study involves an initial screening visit; if your child is able to participate there will be up to 18 follow up visits which will last up to 36 months/144 weeks. You will have to come to the clinic every 1 to 2 months. Part 1 will last up to 12 months and Part 2 will last up to 24 months.

Your child will receive a total of 6 intramuscular injections of study medication (LA 45 mg formulation), 6 months apart:

• The first injection will be on Study Day 1
• The second injection will be at Month 6 (Week 24)
• The third injection will be at Month 12 (Week 48)
• The fourth injection will be at Month 18 (Week 72)
• The fifth injection will be at Month 24 (Week 96)
• The sixth injection will be at Month 30 (Week 120)

A Leuprolide Acetate Stimulation Test will be done, at Screening and at Weeks 4, 12, 20, 24, 44, 48, 72, 96, 120, 144 and/or if your child exit the study early. A stimulation test is when a lower dose of LA is injected under the skin to test if your child has CPP or to check if the study medication is working. Blood samples will be taken three times (before the injection, and at 30 and 60 minutes after the injection). The study doctor may add a tiny needle under the skin to prevent multiple needle sticks to collect these blood samples.