<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/NCT02984722</url>
  </required_header>
  <id_info>
    <org_study_id>Metformin XR</org_study_id>
    <nct_id>NCT02984722</nct_id>
  </id_info>
  <brief_title>Extended-release vs Immediate-release Metformin in PCOS Women</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catholic University of the Sacred Heart</source>
  <brief_summary>
    <textblock>
      The aim of our study is to compare the different effects of 6 months treatment with&#xD;
      extended-release metformin and immediate-release metformin on clinical, endocrine and&#xD;
      metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate&#xD;
      gastrointestinal disorders associated with the two different compouds.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastro intestinal disorders</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of cycles in 6 months of therapy</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>insulin levels</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hirsutism score</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>androstenedione levels</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>testosterone levels</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>free androgen index</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dheas levels</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ovarian volume</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total cholesterol</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tryglycerides levels</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PCOS women treated with 1500 mg/die of extended-release metformin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PCOS women treated with 1500 mg/die of immediate-release metformin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with PCOS in accordance with Rotterdam criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr&#xD;
             oral glucose tolerance test)&#xD;
&#xD;
          -  past history of cardiovascular diseases&#xD;
&#xD;
          -  past history of gastro-intestinal diseases&#xD;
&#xD;
          -  significant liver or renal dysfunction (hypothalamic, pituitary, thiroidal or&#xD;
             adrenal);&#xD;
&#xD;
          -  neoplasms.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Catholic university of Sacred Heart</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catholic University of the Sacred Heart</investigator_affiliation>
    <investigator_full_name>Rosanna Apa</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>PCOS</keyword>
  <keyword>metformin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</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/NCT02984722
org study id: Metformin XR
nct id: NCT02984722
lead sponsor: 
The aim of our study is to compare the different effects of 6 months treatment with
      extended-release metformin and immediate-release metformin on clinical, endocrine and
      metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate
      gastrointestinal disorders associated with the two different compouds.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Gastro intestinal disorders
time frame: 6 months
measure: number of cycles in 6 months of therapy
time frame: 6 months
measure: insulin levels
time frame: 6 months
measure: hirsutism score
time frame: 6 months
measure: androstenedione levels
time frame: 6 months
measure: testosterone levels
time frame: 6 months
measure: free androgen index
time frame: 6 months
measure: dheas levels
time frame: 6 months
measure: ovarian volume
time frame: 6 months
measure: total cholesterol
time frame: 6 months
measure: tryglycerides levels
time frame: 6 months
arm group label: 1
arm group type: Experimental
description: PCOS women treated with 1500 mg/die of extended-release metformin
arm group label: 2
arm group type: Experimental
description: PCOS women treated with 1500 mg/die of immediate-release metformin
intervention type: Drug
intervention name: Metformin
arm group label: 1
arm group label: 2
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Catholic University of the Sacred Heart
investigator full name: Rosanna Apa
investigator title: Professor
mesh term: Polycystic Ovary Syndrome
mesh term: Metformin