<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/NCT04414085</url>
  </required_header>
  <id_info>
    <org_study_id>0183-15-ASF</org_study_id>
    <nct_id>NCT04414085</nct_id>
  </id_info>
  <brief_title>The Clinical Significance of Biochemical 11 Deoxycortisol Levels</brief_title>
  <official_title>The Clinical Significance of Biochemical Polymorphism in the 11 Deoxycortisol Levels Before and After Stimulation With Adrenocorticotrofin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assaf Harofeh MC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assaf-Harofeh Medical Center</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>
      data from charts regarding clinical characteristics and androgens levels from first to last&#xD;
      visit were collected&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      data from charts regarding clinical characteristics and androgens levels from first to last&#xD;
      visit were collected Female patients only ages 10-18 years who were referred to the combined&#xD;
      gynecology endocrinology adolescents clinic&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2015</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of hyperandrogenism signs (1 to 3 categorized)</measure>
    <time_frame>3 years</time_frame>
    <description>hirsuitism, acne, menses, each marked as 0 or 1 (none or present)</description>
  </primary_outcome>
  <enrollment type="Actual">120</enrollment>
  <condition>Retrospective</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All referred to gynecology endocrinology adolescents clinic who underwent an ACTH&#xD;
        stimulation test&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        age 10-18 years referred to gynecology endocrinology adolescents clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        no data available in chart no blood work available&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>galia barash, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assaf-Harofeh Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center</name>
      <address>
        <city>Zerifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assaf-Harofeh Medical Center</investigator_affiliation>
    <investigator_full_name>Assaf Harofeh MC</investigator_full_name>
    <investigator_title>Galia Askapa</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04414085
org study id: 0183-15-ASF
nct id: NCT04414085
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
data from charts regarding clinical characteristics and androgens levels from first to last
      visit were collected
data from charts regarding clinical characteristics and androgens levels from first to last
      visit were collected Female patients only ages 10-18 years who were referred to the combined
      gynecology endocrinology adolescents clinic
observational model: Case-Only
time perspective: Retrospective
measure: Presence of hyperandrogenism signs (1 to 3 categorized)
time frame: 3 years
description: hirsuitism, acne, menses, each marked as 0 or 1 (none or present)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: galia barash, md
role: Principal Investigator
affiliation: Assaf-Harofeh Medical Center
facility: 
country: Israel
responsible party type: Sponsor-Investigator
investigator affiliation: Assaf-Harofeh Medical Center
investigator full name: Assaf Harofeh MC
investigator title: Galia Askapa
sharing ipd: Undecided