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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Leuprorelin
DrugLeuprorelin will be administered every 4 weeks.
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: LeuprorelinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L).
Time frame
24 weeks after treatment initiationSecondary outcomes
1
Peak LH level following GnRH stimulation is < 4 IU/L at 48, 96wk
Time frame
48 weeks and 96 weeks after treatment initiation2
Changes from baseline in endocrine function: basal LH in IU/L, follicle-stimulating hormone (FSH) in IU/L, testosterone (T) in nanograms per deciliter (ng/dL), estradiol (E2) in picograms per milliliter (pg/mL)
Time frame
Up to 96 weeks after treatment initiation3
Changes from baseline in pubertal development: Tanner stage
Time frame
Up to 96 weeks after treatment initiation4
Changes from baseline in growth related parameters: height in centimeter
Time frame
Up to 96 weeks after treatment initiation Source ClinicalTrials.gov