xml: <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/NCT06025409</url>
    </required_header>
    <id_info>
      <org_study_id>DW_DWJ108J301</org_study_id>
      <nct_id>NCT06025409</nct_id>
    </id_info>
    <brief_title>Evaluate the Efficacy and Safety of DWJ108J</brief_title>
    <official_title>A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ108J in Patients With Central Precocious Puberty : A Single-arm, Open-label, Multi-center, Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Daewoong Pharmaceutical Co. LTD.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Daewoong Pharmaceutical Co. LTD.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg)&#xD;
        in patients with central precocious puberty.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The drug in this study is called leuprorelin. It is administered as a 3 month subcutaneous&#xD;
        depot injection. Leuprorelin is used to treat children who have Central Precocious Puberty.&#xD;
        This study will look at whether leuprorelin can stop early Central Precocious Puberty.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2025</primary_completion_date>
    <phase>Phase 3</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>Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.</measure>
      <time_frame>6 months</time_frame>
      <description>Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.</measure>
      <time_frame>3 months</time_frame>
      <description>Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.</measure>
      <time_frame>Baseline, 3 and 6 months</time_frame>
      <description>Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration</measure>
      <time_frame>3 and 6 months</time_frame>
      <description>Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.</measure>
      <time_frame>Baseline, 3 and 6 months</time_frame>
      <description>Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.</measure>
      <time_frame>6 months</time_frame>
      <description>Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average Tanner Stage at 6 months after administration, and the changes compared to before administration.</measure>
      <time_frame>6 months</time_frame>
      <description>Average Tanner Stage at 6 months after administration, and the changes compared to before administration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.</measure>
      <time_frame>6 months</time_frame>
      <description>Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">79</enrollment>
    <condition>Central Precocious Puberty</condition>
    <arm_group>
      <arm_group_label>Experimental: Leuprorelin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with body weight greater than or equal to (≥) 20 kilogram (kg) will receive the recommended dose of leuprorelin 11.25 milligram (mg), injection, subcutaneously, once every 3 months for 6 months. Participants with body weight less than (&lt;) 20 kg will receive leuprorelin 5.625 mg, injection, subcutaneously, once every 3 months for 6 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Leuprolide Acetate 11.25 MG/ML</intervention_name>
      <description>Subcutaneous injection</description>
      <arm_group_label>Experimental: Leuprorelin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at&#xD;
               screening&#xD;
  &#xD;
            2. Diagnosis of central precocious puberty&#xD;
  &#xD;
            3. For boys, those under 10 years old and for girls, those under 9 years old, based on&#xD;
               Visit 2 (Enrollment), with Tanner Stage 2 or above&#xD;
  &#xD;
            4. Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year&#xD;
  &#xD;
            5. In cases where the legal guardian of the child listened to the explanation of this&#xD;
               clinical trial and provided written consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Following conditions at Visit 1(Screening) :&#xD;
  &#xD;
               Conditions related to pseudo precocious puberty, Incomplete precocious puberty,&#xD;
               Dysfunction of pituitary, adrenal, thyroid, or reproductive glands, Growth disorders&#xD;
               or bone diseases that could affect bone growth, Brain tumor, Pituitary adenoma&#xD;
  &#xD;
            2. requires treatment within 6 months of receiving a registration number during the trial&#xD;
               period that could affect the hypothalamic-pituitary-gonadal axis&#xD;
  &#xD;
            3. Prior treatment with GnRH analogues&#xD;
  &#xD;
            4. Hypersensitive to the investigational drug for this clinical trial or GnRH analogues&#xD;
  &#xD;
            5. Prior or current therapy with growth hormone&#xD;
  &#xD;
            6. has taken the following medications within 8 weeks of Visit 1 (Screening): Sex hormone&#xD;
               medications, Sex hormone antagonists, Steroids (local application is allowed; oral&#xD;
               formulations are not allowed if taken within 3 days continuously, and use within 2&#xD;
               weeks of screening is prohibited), Herbal medicine&#xD;
  &#xD;
            7. Meets the following criteria based on screening test results:&#xD;
  &#xD;
               AST, ALT levels exceed twice the upper limit of normal, Creatinine levels exceed 1.5&#xD;
               times the upper limit of normal, Bone age is above 11.5 years&#xD;
  &#xD;
            8. Any other medical condition or serious intercurrent illness that, in the opinion of&#xD;
               the Investigator, may make it undesirable for the subject to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jin Soong Hwang, MD. PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ajou University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yeonseo Choi, MD. PhD</last_name>
      <phone>82-2-550-8800</phone>
      <email>yeonseo@daewoong.co.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ajou University medical center</name>
        <address>
          <city>Gyeonggi-do</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jin Soon Hwang</last_name>
        <phone>82-1688-6114</phone>
        <email>yeonseo@daewoong.co.kr</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025409
  org study id: DW_DWJ108J301
  nct id: NCT06025409
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg)
        in patients with central precocious puberty.
  The drug in this study is called leuprorelin. It is administered as a 3 month subcutaneous
        depot injection. Leuprorelin is used to treat children who have Central Precocious Puberty.
        This study will look at whether leuprorelin can stop early Central Precocious Puberty.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
  time frame: 6 months
  description: Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
  measure: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.
  time frame: 3 months
  description: Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
  measure: Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
  time frame: Baseline, 3 and 6 months
  description: Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
  measure: Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
  time frame: 3 and 6 months
  description: Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
  measure: Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
  time frame: Baseline, 3 and 6 months
  description: Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
  measure: Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
  time frame: 6 months
  description: Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
  measure: Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
  time frame: 6 months
  description: Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
  measure: Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.
  time frame: 6 months
  description: Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.
  arm group label: Experimental: Leuprorelin
  arm group type: Experimental
  description: Participants with body weight greater than or equal to (≥) 20 kilogram (kg) will receive the recommended dose of leuprorelin 11.25 milligram (mg), injection, subcutaneously, once every 3 months for 6 months. Participants with body weight less than (<) 20 kg will receive leuprorelin 5.625 mg, injection, subcutaneously, once every 3 months for 6 months.
  intervention type: Drug
  intervention name: Leuprolide Acetate 11.25 MG/ML
  description: Subcutaneous injection
  arm group label: Experimental: Leuprorelin
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 10 Years
  healthy volunteers: No
  last name: Jin Soong Hwang, MD. PhD
  role: Principal Investigator
  affiliation: Ajou University School of Medicine
  last name: Yeonseo Choi, MD. PhD
  phone: 82-2-550-8800
  email: yeonseo@daewoong.co.kr
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Puberty, Precocious
  mesh term: Leuprolide
  sharing ipd: No