Analysis of Body Mass Index in Central Precocious Puberty... | NCT02974270

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

NCT02974270

Sponsor

Kyungpook National University Hospital

Status

Unknown status

Last Update Posted

Nov 28, 2016Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Precocious Puberty, Central

Interventions

Leuprolide

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Mar 2018Estimated

Completion Date

Not provided

First Submitted Date

May 19, 2016

First Submission Date that Met QC Criteria

Nov 22, 2016

First Posted Date

Nov 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2016

Last Update Posted Date

Nov 28, 2016Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Leuprolide acetate	Experimental		Drug: Leuprolide

Name	Type	Description	Arm Group Labels	Other Names
Leuprolide	Drug		Leuprolide acetate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months		6 months

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months		3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Cheol Woo Ko, MD, PhD	Contact	01082453633		cwko@knu.ac.kr

Facility	Status	City	State	ZIP	Country	Contacts
Cheol Woo Ko	Recruiting	Daegu			South Korea

ID	Term
D011629	Puberty, Precocious

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D016729	Leuprolide

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided