CClinicalTrials.gg
Sign In
Status unknownNCT02974270Updated Nov 28, 2016

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

A Phase 4 interventional study of Leuprolide in Precocious Puberty, Central, sponsored by Kyungpook National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged Up to 9 Years. Per ClinicalTrials.gov, last updated 2016-11-28.

Sponsored by Kyungpook National University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
Up to 9 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Precocious Puberty, Central

Browse trials for

03

In context

Puberty, Precocious

75 studies on the registry are indexed under Puberty, Precocious; 19 are open to participants now.

This study's planned enrollment of 100 is above the median of 64 across 47 interventional studies indexed under Puberty, Precocious.

Browse Puberty, Precocious studies →

Lead sponsor

Kyungpook National University Hospital is the lead sponsor of 76 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Leuprolide acetate

    Drug: Leuprolide

Interventions

  • DrugLeuprolide
06

What researchers measure

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Cheol Woo Ko
    Daegu, Korea, Republic of
    • Cheol Woo Ko, MD, PhD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02974270
Lead sponsor
Kyungpook National University Hospital
Responsible party
Cheol Woo Ko (MD, PhD, Kyungpook National University Hospital) — Principal investigator
First posted
Nov 28, 2016
Start date
Jun 2016
Primary completion
Mar 2018 (estimated)
Last update
Nov 28, 2016

Study contacts

Cheol Woo Ko, MD, PhD
Contact
cwko@knu.ac.kr
01082453633
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Puberty, Precocious→

Other studies from this sponsor

Kyungpook National University Hospital

Start the discussion