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

November 22, 2016 updated by: Cheol Woo Ko, Kyungpook National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cheol Woo Ko, MD, PhD
  • Phone Number: 01082453633
  • Email: cwko@knu.ac.kr

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Recruiting
        • Cheol Woo Ko
        • Contact:
          • Cheol Woo Ko, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Leuprolide acetate
Drug: Leuprolide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Estimate)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IISR-2014-100760

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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