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/NCT06033521</url>
    </required_header>
    <id_info>
      <org_study_id>B2311076</org_study_id>
      <secondary_id>MHT RWD</secondary_id>
      <nct_id>NCT06033521</nct_id>
    </id_info>
    <brief_title>A Study to Learn More About the Menopausal Hormone Therapies in Korea</brief_title>
    <official_title>Treatment Patterns of Menopausal Hormone Therapy in South Korea: a Nationwide Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pfizer</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to learn about how the commonly used menopausal hormone&#xD;
        therapies were prescribed and taken in practice. This is done by using healthcare database,&#xD;
        to study the overall dangers and benefits of menopausal hormone therapies in real-world&#xD;
        practice.&#xD;
  &#xD;
        This study will include subjects who were newly diagnosed menopausal symptoms between 2012&#xD;
        and 2019. They were all followed up for 12 months at least.&#xD;
  &#xD;
        The study included the below subjects who:&#xD;
  &#xD;
          -  were aged 40-59 years&#xD;
  &#xD;
          -  were diagnosed to have menopausal symptoms through some medical check-ups&#xD;
  &#xD;
        The data collected will be used to understand:&#xD;
  &#xD;
          -  how the commonly used menopausal hormone therapies were prescribed and taken in practice&#xD;
  &#xD;
          -  how patients took medication as prescribed by their doctors This might help to&#xD;
             understand treatment trends of these therapies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Prevalence of menopausal symptoms</measure>
      <time_frame>365 days</time_frame>
      <description>Calculated as the number of women diagnosed with menopausal symptoms divided by the mid-year population of women (age 40-59 years).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of menopausal symptoms with Menopausal Hormone Therapy (MHT)</measure>
      <time_frame>365 days</time_frame>
      <description>Calculated as the number of women diagnosed with menopausal symptoms and prescribed with MHT divided by the mid-year population of women (ages 40 - 59 years)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of menopausal symptom: bone and joint symptoms</measure>
      <time_frame>365 days</time_frame>
      <description>The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of menopausal symptom: vasomotor symptoms</measure>
      <time_frame>365 days</time_frame>
      <description>The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of menopausal symptom: genitourinary symptoms</measure>
      <time_frame>365 days</time_frame>
      <description>The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of menopausal symptom: psychosomatic symptoms</measure>
      <time_frame>365 days</time_frame>
      <description>The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trends in prevalence of MHT by treatment</measure>
      <time_frame>90 days</time_frame>
      <description>include estrogen therapy, estrogen-progestin therapy and tibolone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trends in prevalence of MHT by age</measure>
      <time_frame>90 days</time_frame>
      <description>include ages (40-44), (45-49), (50-54), and (55-59)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tends in prevalence of MHT by symptom</measure>
      <time_frame>90 days</time_frame>
      <description>include vasomotor symptoms, bone and joint symptoms, genitourinary symptoms, and psychosomatic symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trends in Prevalence of MHT by type of administration</measure>
      <time_frame>90 days</time_frame>
      <description>include systemic hormone therapies (oral), systemic hormone therapies (transdermal) and local hormone therapies (transvaginal)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of treatment regimens change of MHT across time</measure>
      <time_frame>90 days</time_frame>
      <description>Treatment switch and discontinuation patterns across time by measuring the number of different classes of MHT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to switch and discontinuation of MHT</measure>
      <time_frame>365 days</time_frame>
      <description>The time to non-persistence events including switch and discontinuation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Adherence using medication possession ratio (MPR)</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">4293747</enrollment>
    <condition>Menopause</condition>
    <condition>Bone Demineralization</condition>
    <arm_group>
      <arm_group_label>Women with menopausal hormone therapy</arm_group_label>
      <description>Subjects who were newly diagnosed menopausal symptoms between 01 Jan 2012 and 31 Dec 2019, and were followed up for 12 months at least in the HIRA claims database</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Menopausal hormone therapy Intervention Type: Drug</intervention_name>
      <description>Subjects who were newly diagnosed menopausal symptoms between 01 Jan 2012 and 31 Dec 2019, and were followed up for 12 months at least in the HIRA claims database</description>
      <arm_group_label>Women with menopausal hormone therapy</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects who were newly diagnosed menopausal symptoms between 01 Jan 2012 and 31 Dec 2019,&#xD;
          and were followed up for 12 months at least in the HIRA claims database&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 40-59 years at cohort entry date&#xD;
  &#xD;
            -  Patients who had at least one inpatient or outpatient diagnosis of menopausal symptoms&#xD;
               between 01 Jan 2012 and 31 Dec 2019 with any of following diagnosis codes: N95.1,&#xD;
               N95.2, N95.3, N95.8, N95.9, M80.0, M81.0, M81.99, M85.99&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with breast cancer (C50, D05), endometrial cancer (C54.1), and&#xD;
               granulosa cell tumor (C56) within 1 year prior to the index date.&#xD;
  &#xD;
            -  Patients diagnosed with coronary heart disease (I20-I25, I51.6), stroke (I60-64), and&#xD;
               VTE (I80.2, I80.3 I26) within 1 year prior to the index date.&#xD;
  &#xD;
            -  Patients diagnosed with viral hepatitis (B16-B19), cirrhosis (K70.2-K70.4, K71.7,&#xD;
               K72.0-K72.1, K72.9, K74.0-K74.6, K76.1, K76.6-K76.7, R18, I85.0, I85.9, I86.4, I86.8,&#xD;
               I98.2-I98.3), and hepatic cancer (C22) within 1 year prior to the index date.&#xD;
  &#xD;
            -  Patients diagnosed with gallbladder disease (K80, K81, K82, K83, K85.1), gallbladder&#xD;
               cancer (C23), extrahepatic bile duct cancer (C24) within 1 year prior to the index&#xD;
               date.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>59 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <role>Study Director</role>
      <affiliation>Pfizer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Menopause</keyword>
    <keyword>Bone Demineralization</keyword>
    <keyword>Hormone Replacement Therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bone Demineralization, Pathologic</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hormones</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    </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/NCT06033521
  org study id: B2311076
  secondary id: MHT RWD
  nct id: NCT06033521
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to learn about how the commonly used menopausal hormone
        therapies were prescribed and taken in practice. This is done by using healthcare database,
        to study the overall dangers and benefits of menopausal hormone therapies in real-world
        practice.
  
        This study will include subjects who were newly diagnosed menopausal symptoms between 2012
        and 2019. They were all followed up for 12 months at least.
  
        The study included the below subjects who:
  
          -  were aged 40-59 years
  
          -  were diagnosed to have menopausal symptoms through some medical check-ups
  
        The data collected will be used to understand:
  
          -  how the commonly used menopausal hormone therapies were prescribed and taken in practice
  
          -  how patients took medication as prescribed by their doctors This might help to
             understand treatment trends of these therapies.
  observational model: Cohort
  time perspective: Retrospective
  measure: Prevalence of menopausal symptoms
  time frame: 365 days
  description: Calculated as the number of women diagnosed with menopausal symptoms divided by the mid-year population of women (age 40-59 years).
  measure: Prevalence of menopausal symptoms with Menopausal Hormone Therapy (MHT)
  time frame: 365 days
  description: Calculated as the number of women diagnosed with menopausal symptoms and prescribed with MHT divided by the mid-year population of women (ages 40 - 59 years)
  measure: Prevalence of menopausal symptom: bone and joint symptoms
  time frame: 365 days
  description: The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT.
  measure: Prevalence of menopausal symptom: vasomotor symptoms
  time frame: 365 days
  description: The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT.
  measure: Prevalence of menopausal symptom: genitourinary symptoms
  time frame: 365 days
  description: The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT.
  measure: Prevalence of menopausal symptom: psychosomatic symptoms
  time frame: 365 days
  description: The prevalence of each menopausal symptom among patients with MHT will be calculated as the number of patients diagnosed with each menopausal symptom divided by the number of patients prescribed for MHT.
  measure: Trends in prevalence of MHT by treatment
  time frame: 90 days
  description: include estrogen therapy, estrogen-progestin therapy and tibolone
  measure: Trends in prevalence of MHT by age
  time frame: 90 days
  description: include ages (40-44), (45-49), (50-54), and (55-59)
  measure: Tends in prevalence of MHT by symptom
  time frame: 90 days
  description: include vasomotor symptoms, bone and joint symptoms, genitourinary symptoms, and psychosomatic symptoms
  measure: Trends in Prevalence of MHT by type of administration
  time frame: 90 days
  description: include systemic hormone therapies (oral), systemic hormone therapies (transdermal) and local hormone therapies (transvaginal)
  measure: Number of treatment regimens change of MHT across time
  time frame: 90 days
  description: Treatment switch and discontinuation patterns across time by measuring the number of different classes of MHT
  measure: Time to switch and discontinuation of MHT
  time frame: 365 days
  description: The time to non-persistence events including switch and discontinuation
  measure: Treatment Adherence using medication possession ratio (MPR)
  time frame: 90 days
  arm group label: Women with menopausal hormone therapy
  description: Subjects who were newly diagnosed menopausal symptoms between 01 Jan 2012 and 31 Dec 2019, and were followed up for 12 months at least in the HIRA claims database
  intervention type: Drug
  intervention name: Menopausal hormone therapy Intervention Type: Drug
  description: Subjects who were newly diagnosed menopausal symptoms between 01 Jan 2012 and 31 Dec 2019, and were followed up for 12 months at least in the HIRA claims database
  arm group label: Women with menopausal hormone therapy
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 40 Years
  maximum age: 59 Years
  healthy volunteers: No
  last name: Pfizer CT.gov Call Center
  role: Study Director
  affiliation: Pfizer
  last name: Pfizer CT.gov Call Center
  phone: 1-800-718-1021
  email: ClinicalTrials.gov_Inquiries@pfizer.com
  responsible party type: Sponsor
  mesh term: Bone Demineralization, Pathologic
  mesh term: Hormones
  sharing ipd: No
  ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.