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

Primary Purpose

Precocious Puberty, Central

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Leuprolide
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Precocious Puberty, Central

Eligibility Criteria

undefined - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cheol Woo KoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Leuprolide acetate

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months

Full Information

First Posted
May 19, 2016
Last Updated
November 22, 2016
Sponsor
Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02974270
Brief Title
Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate
Official Title
Analysis of Body Mass Index in Central Precocious Puberty(CPP) Patients Treated With Leuprolide Acetate
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precocious Puberty, Central

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Leuprolide acetate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Leuprolide
Primary Outcome Measure Information:
Title
Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheol Woo Ko, MD, PhD
Phone
01082453633
Email
cwko@knu.ac.kr
Facility Information:
Facility Name
Cheol Woo Ko
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheol Woo Ko, MD, PhD

12. IPD Sharing Statement

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

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