Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate
- Registration Number
- NCT02974270
- Lead Sponsor
- Kyungpook National University Hospital
- Brief Summary
Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide acetate
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Child diagnosed with CPP who has a peak-stimulated Lutenizing Hormone(LH) concentration over 5 IU/liter before initiation of therapy
- Chronological age(CA) at the appearance of pubertal changes less than 8 years in girls and less than 9 years in boys.
- Tanner stage ≥2
- Advanced bone age (Bone Age/Chronological Age >1.1)
- Able to have the signed written informed consent provided by the patients' parents or legal guardians prior to any study-related procedures
Exclusion Criteria
- Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion
- Patient with a cerebral tumor requiring a neurosurgery or cerebral irradiation known chronic disease of underlying medical condition
- Currently on or planning growth hormone treatment
- Previous Gonadotropin-Releasing Hormone agonist treatment
- Any patient who in opinion of the investigator should not participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Leuprolide acetate Leuprolide -
- Primary Outcome Measures
Name Time Method Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months 6 months
- Secondary Outcome Measures
Name Time Method Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months 3 months
Trial Locations
- Locations (1)
Cheol Woo Ko
🇰🇷Daegu, Korea, Republic of