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

Phase 4

• Conditions: Precocious Puberty, Central
• Interventions: Drug: Leuprolide

• 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

Study Timeline

• Study First Submitted: 2016-05-19
• Study Start: 2016-06
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-22
• Last Update Submitted: 2016-11-22
• Study First Posted: 2016-11-28
• Last Update Posted: 2016-11-28
• Primary Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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