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A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty

Investigating Debio 4326 for children with early puberty receiving treatment.

Recruiting
5-8 years
All
Phase 3

This study aims to see if a drug called Debio 4326 can help children with a condition known as Central Precocious Puberty (CPP). CPP is when a child's body starts developing adult features too early. Children in the study are already getting a type of medicine called GnRHa therapy to help manage CPP. The study will last for 52 weeks (about a year) and will look at how good Debio 4326 is at keeping a hormone called luteinizing hormone (LH) at low levels, like in younger kids. LH is important because it can cause the body to start growing and changing.

  • Participation involves at least one year of treatment.
  • Eligibility includes specific age and puberty signs, with restrictions on other conditions.
  • Requires regular monitoring and no prior use of certain medicines.
Study details
    Central Precocious Puberty

NCT06129539

Debiopharm International SA

2 March 2025

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