← Back to all trials
Active Not Recruiting
NCT06129539
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
Conditions: Central Precocious Puberty
Sex: All
Ages: 5 Years – 8 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 56
Sponsor: Debiopharm International SA
Location: Rady Children's Hospital - San Diego San Diego California
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 with central precocious puberty (CPP).
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of central precocious puberty.
2. Onset of development of sex characteristics (i.e., breast development in girls or testicular enlargement in boys according to the Tanner method) before the age of 8 years in girls and 9 years in boys.
3. Initially, only participants aged (a) 5 to 8 years inclusive (i.e., \
Source: ClinicalTrials.gov (NCT06129539). StuddyBuddy aggregates publicly available trial information.
