NCT02974270

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

May 19, 2016

Last Update Submit

November 22, 2016

Conditions

Precocious Puberty, Central

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

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

    3 months

Study Arms (1)

Leuprolide acetate

EXPERIMENTAL
Drug: Leuprolide

Interventions

LeuprolideDRUG
Leuprolide acetate

Eligibility Criteria

AgeUp to 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheol Woo Ko

Daegu, South Korea

RECRUITING

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Central Study Contacts

Cheol Woo Ko, MD, PhD

CONTACT

01082453633cwko@knu.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 19, 2016

First Posted

November 28, 2016

Study Start

June 1, 2016

Primary Completion

March 1, 2018

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

KR(1)