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A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)

Researching Debio 4326 for early puberty in children.

Recruiting
5-8 years
All
Phase 3

Study Overview: This study checks how well a medicine called Debio 4326 works for children with central precocious puberty (CPP). CPP is when a child's body starts developing into an adult too early. The medicine aims to lower a hormone called luteinizing hormone (LH) to levels found in younger kids. This study will last for 52 weeks, and it's for kids already getting a treatment called gonadotropin-releasing hormone agonist (GnRHa) therapy.

Eligibility:

  • Children aged 5-8 years with early puberty signs can join.
  • Participants must have started puberty signs before age 8 in girls or 9 in boys.
  • The children should have been on GnRHa therapy for less than 18 months.

Exclusions: Kids with other types of early puberty, certain tumors, or conditions that affect growth can't join. Kids using some other medicines or with specific health issues like seizures are also not eligible.

Key Points:

  • The study lasts 1 year with regular check-ups.
  • Participants may need to stop certain medicines.
  • Potential benefits include better control of early puberty symptoms.
Study details
    Central Precocious Puberty

NCT06129539

Debiopharm International SA

28 June 2025

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