<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02974270</url>
  </required_header>
  <id_info>
    <org_study_id>IISR-2014-100760</org_study_id>
    <nct_id>NCT02974270</nct_id>
  </id_info>
  <brief_title>Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate</brief_title>
  <official_title>Analysis of Body Mass Index in Central Precocious Puberty(CPP) Patients Treated With Leuprolide Acetate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyungpook National University Hospital</source>
  <brief_summary>
    <textblock>
      Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide&#xD;
      acetate&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Precocious Puberty, Central</condition>
  <arm_group>
    <arm_group_label>Leuprolide acetate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leuprolide</intervention_name>
    <arm_group_label>Leuprolide acetate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Child diagnosed with CPP who has a peak-stimulated Lutenizing Hormone(LH)&#xD;
             concentration over 5 IU/liter before initiation of therapy&#xD;
&#xD;
          2. Chronological age(CA) at the appearance of pubertal changes less than 8 years in girls&#xD;
             and less than 9 years in boys.&#xD;
&#xD;
          3. Tanner stage ≥2&#xD;
&#xD;
          4. Advanced bone age (Bone Age/Chronological Age &gt;1.1)&#xD;
&#xD;
          5. Able to have the signed written informed consent provided by the patients' parents or&#xD;
             legal guardians prior to any study-related procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with a peripheral precocious puberty: extrapituitary secretion of&#xD;
             gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion&#xD;
&#xD;
          2. Patient with a cerebral tumor requiring a neurosurgery or cerebral irradiation known&#xD;
             chronic disease of underlying medical condition&#xD;
&#xD;
          3. Currently on or planning growth hormone treatment&#xD;
&#xD;
          4. Previous Gonadotropin-Releasing Hormone agonist treatment&#xD;
&#xD;
          5. Any patient who in opinion of the investigator should not participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Cheol Woo Ko, MD, PhD</last_name>
    <phone>01082453633</phone>
    <email>cwko@knu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cheol Woo Ko</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheol Woo Ko, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>May 19, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyungpook National University Hospital</investigator_affiliation>
    <investigator_full_name>Cheol Woo Ko</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Puberty, Precocious</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leuprolide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02974270
org study id: IISR-2014-100760
nct id: NCT02974270
lead sponsor: 
Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide
      acetate
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months
time frame: 6 months
measure: Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months
time frame: 3 months
arm group label: Leuprolide acetate
arm group type: Experimental
intervention type: Drug
intervention name: Leuprolide
arm group label: Leuprolide acetate
criteria: 
gender: All
minimum age: N/A
maximum age: 9 Years
healthy volunteers: No
last name: Cheol Woo Ko, MD, PhD
phone: 01082453633
email: cwko@knu.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Hospital
investigator full name: Cheol Woo Ko
investigator title: MD, PhD
mesh term: Puberty, Precocious
mesh term: Leuprolide