<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/NCT01685762</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC 1205</org_study_id>
    <nct_id>NCT01685762</nct_id>
  </id_info>
  <brief_title>Metformin for the Treatment of Endometrial Hyperplasia</brief_title>
  <official_title>Metformin for the Treatment of Endometrial Hyperplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if metformin will be effective in making endometrial&#xD;
      hyperplasia without atypia better by returning the tissue to a normal state.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-institutional pilot clinical trial designed to estimate the response rate and&#xD;
      safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH)&#xD;
      without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines&#xD;
      Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin&#xD;
      will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum&#xD;
      of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat&#xD;
      endometrial biopsy to assess for regression or persistence of EH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2013</start_date>
  <completion_date type="Actual">December 1, 2015</completion_date>
  <primary_completion_date type="Actual">December 1, 2015</primary_completion_date>
  <phase>Early Phase 1</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>Response Rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Toxicity evaluation</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of subjects who experience side effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Compliance</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage of patients successfully completing metformin therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential molecular markers in response to treatment with Metformin</measure>
    <time_frame>12 weeks</time_frame>
    <description>Compare changes in potential biomarkers, including metabolic factors and molecular markers of downstream targets of the metformin/mTOR signaling pathway, before and after metformin treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Endometrial Hyperplasia</condition>
  <condition>Endometrial Hyperplasia Without Atypia</condition>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>850 mg of metformin taken once daily by mouth for 4 weeks (weeks 1-4) and then twice daily by mouth for 8 weeks (weeks 5-12).</description>
    <arm_group_label>Metformin</arm_group_label>
    <other_name>Fortamet</other_name>
    <other_name>Glucophage</other_name>
    <other_name>Glumetza</other_name>
    <other_name>Riomet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be between the ages of 18-75 years old&#xD;
&#xD;
          -  Have a confirmed diagnosis of endometrial hyperplasia without atypia based upon&#xD;
             endometrial biopsy&#xD;
&#xD;
          -  Have no contraindications to short-term metformin therapy&#xD;
&#xD;
          -  Have a creatinine clearance of ≥ 90 ml/min, as calculated by the Cockroft-Gault&#xD;
             formula&#xD;
&#xD;
          -  Have normal serum transaminase values (AST and ALT)&#xD;
&#xD;
          -  Need to be able to undergo metformin treatment for a duration of 12 weeks prior to&#xD;
             repeat endometrial biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are currently taking metformin or have taken metformin in the past 6 months or have a&#xD;
             history of an allergic reaction or intolerance at any time to metformin&#xD;
&#xD;
          -  Have a history of liver or renal dysfunction.&#xD;
&#xD;
          -  Have a random glucose of ≤ 65 or ≥ 200&#xD;
&#xD;
          -  Have a recent history of alcoholism. Former alcoholics who have abstained from alcohol&#xD;
             for 5 years or more may be enrolled in this study.&#xD;
&#xD;
          -  Have a history of vitamin B12 deficiency&#xD;
&#xD;
          -  Are pregnant&#xD;
&#xD;
          -  Are currently taking insulin&#xD;
&#xD;
          -  Are taking a drug that may significantly interact or influence the metabolism of&#xD;
             metformin&#xD;
&#xD;
          -  In the opinion of the investigator, the patient is felt not to be appropriate for the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria Bae-Jump, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Pines Women's Health Center</name>
      <address>
        <city>Southern Pines</city>
        <state>North Carolina</state>
        <zip>28388</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://unclineberger.org</url>
    <description>UNC Lineberger Comprehensive Cancer Center</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometrial hyperplasia</keyword>
  <keyword>Uterus</keyword>
  <keyword>Pilot</keyword>
  <keyword>Metformin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</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/NCT01685762
org study id: LCCC 1205
nct id: NCT01685762
lead sponsor: 
has dmc: Yes
The purpose of this study is to see if metformin will be effective in making endometrial
      hyperplasia without atypia better by returning the tissue to a normal state.
This is a multi-institutional pilot clinical trial designed to estimate the response rate and
      safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH)
      without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines
      Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin
      will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum
      of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat
      endometrial biopsy to assess for regression or persistence of EH.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response Rate
time frame: 12 weeks
description: Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
measure: Toxicity evaluation
time frame: 12 weeks
description: Number of subjects who experience side effects
measure: Patient Compliance
time frame: 12 weeks
description: Percentage of patients successfully completing metformin therapy.
measure: Potential molecular markers in response to treatment with Metformin
time frame: 12 weeks
description: Compare changes in potential biomarkers, including metabolic factors and molecular markers of downstream targets of the metformin/mTOR signaling pathway, before and after metformin treatment.
arm group label: Metformin
arm group type: Experimental
description: Metformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12).
intervention type: Drug
intervention name: Metformin
description: 850 mg of metformin taken once daily by mouth for 4 weeks (weeks 1-4) and then twice daily by mouth for 8 weeks (weeks 5-12).
arm group label: Metformin
other name: Fortamet
other name: Glucophage
other name: Glumetza
other name: Riomet
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Victoria Bae-Jump, MD, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
facility: 
facility: 
country: United States
url: http://unclineberger.org
description: UNC Lineberger Comprehensive Cancer Center
responsible party type: Sponsor
mesh term: Endometrial Hyperplasia
mesh term: Hyperplasia
mesh term: Metformin