A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty
ConditionCentral Precocious Puberty
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 10
SponsorLG Chem
About this trial
A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children with Central Precocious Puberty
Eligibility criteria
Qualifiers
Tanner stage =>2
Girls younger than 9 years old, boys younger than 10 years old
Subjects who are diagnosed with central precocious puberty (CPP)
Disqualifiers
GnRH-independent precocious puberty, incomplete precocious puberty, progressive brain tumors, pituitary adenoma
Hepatic impairment or abnormal liver function tests at screening
Renal impairment or abnormal renal function at screening
Use of following within 8 weeks prior to screening or during the study: medications affecting gonadotropin or sex hormone, systemic steroids, herbal medications
Trial design
Treatments tested in this trial
- Leuprorelin
Treatment groups
43 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov