UnknownPhase 4

Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate

South Korea100 participantsStarted 2016-06

Plain-language summary

Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide acetate

Age range9 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months

Timeframe: 6 months

NCT IDNCT02974270

SponsorKyungpook National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03

Cheol Woo Ko, MD, PhD