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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 — LIBELULA  

Central Precocious Puberty Clinical Trial

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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06129539
Study type Interventional
Source Debiopharm International SA
Contact Debiopharm International S.A
Phone +41 21 321 01 11
Email clinicaltrials@debiopharm.com
Status Recruiting
Phase Phase 3
Start date July 2024
Completion date September 2027
View Details
See also
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Completed NCT01467882 - Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty Phase 3
Recruiting NCT00438217 - Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children Phase 4