Summary

Eligibility
for people ages 5-8 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants receiving gonadotropin-releasing hormone agonist (GnRHa) therapy for central precocious puberty (CPP).

Official Title

An Open-Label, Single-Arm, Multi-Center, Phase 3 Study on the Efficacy, Safety, and Pharmacokinetics of Debio 4326, a Triptorelin 12-month Formulation, in Pediatric Participants Who Are Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty

Keywords

Central Precocious Puberty, Precocious Puberty, Debio 4326

Eligibility

Locations

  • UCSF-Benioff Children's Hospital accepting new patients
    San Francisco California 94143 United States
  • Rady Children's Hospital - San Diego accepting new patients
    San Diego California 92123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Debiopharm International SA
ID
NCT06129539
Phase
Phase 3 Central Precocious Puberty Research Study
Study Type
Interventional
Participants
Expecting 53 study participants
Last Updated