Precocious Puberty, Central
Conditions
Brief summary
Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide acetate
Interventions
DRUGLeuprolide
Sponsors
Kyungpook National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 9 Years
Healthy volunteers
No
Inclusion criteria
1. Child diagnosed with CPP who has a peak-stimulated Lutenizing Hormone(LH) concentration over 5 IU/liter before initiation of therapy 2. Chronological age(CA) at the appearance of pubertal changes less than 8 years in girls and less than 9 years in boys. 3. Tanner stage ≥2 4. Advanced bone age (Bone Age/Chronological Age \>1.1) 5. Able to have the signed written informed consent provided by the patients' parents or legal guardians prior to any study-related procedures
Exclusion criteria
1. Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion 2. Patient with a cerebral tumor requiring a neurosurgery or cerebral irradiation known chronic disease of underlying medical condition 3. Currently on or planning growth hormone treatment 4. Previous Gonadotropin-Releasing Hormone agonist treatment 5. Any patient who in opinion of the investigator should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months | 3 months |
Countries
South Korea
Contacts
Primary ContactCheol Woo Ko, MD, PhD
Outcome results
None listed