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/NCT05972928</url>
    </required_header>
    <id_info>
      <org_study_id>Sitagliptin PCO</org_study_id>
      <nct_id>NCT05972928</nct_id>
    </id_info>
    <brief_title>Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients</brief_title>
    <official_title>Effect of Sitagliptin on Clinical, Metabolic and Hormonal Parameters in Polycystic Ovarian Syndrome Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The Study aims to determine the proposed positive influence of Sitagliptin in manipulating&#xD;
        hormonal , metabolic and inflammatory parameters in the treatment of Polycystic ovary&#xD;
        syndrome and subsequent infertility&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study Design : a Prospective Randomized Controlled Trial.&#xD;
  &#xD;
        A Total of 80 infertile Adult Females aged between 18 and 45 years currently diagnosed with&#xD;
        Polycystic ovary syndrome , Meeting the Diagnosis of Rotterdam criteria be diagnosed if any&#xD;
        two of the following are present: (1) clinical or biochemical hyperandrogenism, (2) evidence&#xD;
        of oligo-anovulation, (3) polycystic appearing-ovarian morphology on ultrasound are to be&#xD;
        included in the study.&#xD;
  &#xD;
        The study will include two groups; each group consists of 40 patients:- Group A : Control&#xD;
        Group Group B : Test Group ( will Receive Sitagliptin at a dose of 100 mg every 24 hours&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Body weight loss in Kilograms</measure>
      <time_frame>3 months</time_frame>
      <description>Body weight before - Body weight after</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Polycystic Ovary Syndrome</condition>
    <arm_group>
      <arm_group_label>Sitagliptin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sitagliptin at a dose of 100 mg every 24 hours for 3 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>patient won't receive medication</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sitagliptin 100mg</intervention_name>
      <description>Sitagliptin at a dose of 100 mg every 24 hours for 3 months</description>
      <arm_group_label>Sitagliptin</arm_group_label>
      <other_name>Januvia 100 mg tab</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          polycystic ovary syndrome usually diagnosed based on the Rotterdam criteria if 2 of 3&#xD;
          criteria are present:&#xD;
  &#xD;
            1. oligo- and/or anovulation&#xD;
  &#xD;
            2. hyperandrogenism (HA) (clinical and/or biochemical)&#xD;
  &#xD;
            3. polycystic ovary morphology (PCOM) on ultrasonography (either 12 or more follicles&#xD;
               measuring 2-9 mm in diameter and/or an increased ovarian volume &gt;10 cm3).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. congenital adrenal hyperplasia&#xD;
  &#xD;
            2. Brittle control of a thyroid disorder&#xD;
  &#xD;
            3. Diabetic on Metformin or any another antidiabetic drugs affecting insulin resistance&#xD;
  &#xD;
            4. chronic kidney disease&#xD;
  &#xD;
            5. liver dysfunction&#xD;
  &#xD;
            6. documented use of oral hormonal contraceptives and hormone-releasing implants in the&#xD;
               past 6 months prior to study entry 7.Lipid lowering Consumption&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Beni-suef University</last_name>
      <phone>082 2318605</phone>
      <phone_ext>02</phone_ext>
      <email>fom@med.bsu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beni-suef university Hospital</name>
        <address>
          <city>Banī Suwayf</city>
          <state>Beni Suef</state>
          <zip>62521</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>Sara Abdallah Mohamed Salem</investigator_full_name>
      <investigator_title>Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University</investigator_title>
    </responsible_party>
    <keyword>Polycystic Ovary Syndrome</keyword>
    <keyword>Sitagliptin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polycystic Ovary Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sitagliptin Phosphate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05972928
  org study id: Sitagliptin PCO
  nct id: NCT05972928
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The Study aims to determine the proposed positive influence of Sitagliptin in manipulating
        hormonal , metabolic and inflammatory parameters in the treatment of Polycystic ovary
        syndrome and subsequent infertility
  Study Design : a Prospective Randomized Controlled Trial.
  
        A Total of 80 infertile Adult Females aged between 18 and 45 years currently diagnosed with
        Polycystic ovary syndrome , Meeting the Diagnosis of Rotterdam criteria be diagnosed if any
        two of the following are present: (1) clinical or biochemical hyperandrogenism, (2) evidence
        of oligo-anovulation, (3) polycystic appearing-ovarian morphology on ultrasound are to be
        included in the study.
  
        The study will include two groups; each group consists of 40 patients:- Group A : Control
        Group Group B : Test Group ( will Receive Sitagliptin at a dose of 100 mg every 24 hours
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Body weight loss in Kilograms
  time frame: 3 months
  description: Body weight before - Body weight after
  arm group label: Sitagliptin
  arm group type: Experimental
  description: Sitagliptin at a dose of 100 mg every 24 hours for 3 months
  arm group label: control
  arm group type: No Intervention
  description: patient won't receive medication
  intervention type: Drug
  intervention name: Sitagliptin 100mg
  description: Sitagliptin at a dose of 100 mg every 24 hours for 3 months
  arm group label: Sitagliptin
  other name: Januvia 100 mg tab
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Beni-suef University
  phone: 082 2318605
  phone ext: 02
  email: fom@med.bsu.edu.eg
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: Sara Abdallah Mohamed Salem
  investigator title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
  mesh term: Polycystic Ovary Syndrome
  mesh term: Syndrome
  mesh term: Sitagliptin Phosphate
  sharing ipd: Undecided