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/NCT05965908</url>
    </required_header>
    <id_info>
      <org_study_id>Liraglutide Polycystic Ovary</org_study_id>
      <nct_id>NCT05965908</nct_id>
    </id_info>
    <brief_title>Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome</brief_title>
    <official_title>Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome</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 aim of this study is to compare the hormonal, metabolic and clinical effects of metformin&#xD;
        and liraglutide in infertile women with PCOs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It is a Prospective randomized controlled trial .The study will include 80 randomly selected&#xD;
        infertile women aged between 18 and 45 years, from Gynecology and obstetrics department&#xD;
        Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), The&#xD;
        study will include two groups; each group consists of 40 patients:-&#xD;
  &#xD;
          -  Group1 (n=40) will be treated by liraglutide monotherapy.&#xD;
  &#xD;
          -  Group 2 (n=40) will be treated by metformin monotherapy.&#xD;
  &#xD;
          -  Group 3 (n=40) will be a control group.&#xD;
  &#xD;
        To assess the metabolic effect of each treatment, the following parameters will be assessed&#xD;
        before and after the treatment&#xD;
  &#xD;
          -  To assess the hormonal effect of each treatment, the following tests will be assessed&#xD;
             before and after treatment&#xD;
  &#xD;
          -  Total Testosterone (TT)&#xD;
  &#xD;
          -  Dehydroepiandrosterone (DHEA)&#xD;
  &#xD;
        To assess the clinical effect of the drugs, the following will be assessed before and after&#xD;
        treatment:&#xD;
  &#xD;
        The number of medium size follicles and large size follicles and the endometrium thickness&#xD;
        were assessed on the tenth or eleventh day of menstruation. The chemical and clinical&#xD;
        pregnancy rates were evaluated&#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">September 30, 2023</primary_completion_date>
    <phase>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</measure>
      <time_frame>1 months</time_frame>
      <description>basal body weight - body weight reached after treatment</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Polycystic Ovary</condition>
    <arm_group>
      <arm_group_label>liraglutide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Saxenda® starting dose is 0.6 mg per day for 1 week.1. Patients increase the dose by 0.6 mg each week until the full maintenance dose of 3 mg is reached</description>
    </arm_group>
    <arm_group>
      <arm_group_label>metformin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the patient is given Glucophage 1000 mg tab once daily after lunch for 1month</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>not given any drug</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>liraglutide</intervention_name>
      <description>glucagon-like peptide 1 receptor agonist</description>
      <arm_group_label>liraglutide</arm_group_label>
      <other_name>saxenda ampoules</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Metformin</intervention_name>
      <description>biguanide antihyperglycemic</description>
      <arm_group_label>metformin</arm_group_label>
      <other_name>Glucophage 1000mg</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  aged between 20 and 45 years&#xD;
  &#xD;
            -  PCO&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. congenital adrenal hyperplasia&#xD;
  &#xD;
            2. poorly controlled thyroid disease&#xD;
  &#xD;
            3. Taking antidiabetic drugs which can affect insulin resistance&#xD;
  &#xD;
            4. chronic kidney disease and history of recurrent urinary tract infections&#xD;
  &#xD;
            5. liver dysfunction&#xD;
  &#xD;
            6. documented use of oral hormonal contraceptives and hormone-releasing implants&#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_official>
      <last_name>Beni-Suef University</last_name>
      <role>Study Director</role>
      <affiliation>Clinical Pharmacy Faculty of Pharmacy Beni-Suef University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sara A Salem, MD</last_name>
      <phone>01272842226</phone>
      <phone_ext>02</phone_ext>
      <email>sara_abdallah100@yahoo.com</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>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 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</keyword>
    <keyword>liraglutide</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>
      <mesh_term>Liraglutide</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>all collected data</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    </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/NCT05965908
  org study id: Liraglutide Polycystic Ovary
  nct id: NCT05965908
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin
        and liraglutide in infertile women with PCOs.
  It is a Prospective randomized controlled trial .The study will include 80 randomly selected
        infertile women aged between 18 and 45 years, from Gynecology and obstetrics department
        Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), The
        study will include two groups; each group consists of 40 patients:-
  
          -  Group1 (n=40) will be treated by liraglutide monotherapy.
  
          -  Group 2 (n=40) will be treated by metformin monotherapy.
  
          -  Group 3 (n=40) will be a control group.
  
        To assess the metabolic effect of each treatment, the following parameters will be assessed
        before and after the treatment
  
          -  To assess the hormonal effect of each treatment, the following tests will be assessed
             before and after treatment
  
          -  Total Testosterone (TT)
  
          -  Dehydroepiandrosterone (DHEA)
  
        To assess the clinical effect of the drugs, the following will be assessed before and after
        treatment:
  
        The number of medium size follicles and large size follicles and the endometrium thickness
        were assessed on the tenth or eleventh day of menstruation. The chemical and clinical
        pregnancy rates were evaluated
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Body weight loss
  time frame: 1 months
  description: basal body weight - body weight reached after treatment
  arm group label: liraglutide
  arm group type: Experimental
  description: Saxenda® starting dose is 0.6 mg per day for 1 week.1. Patients increase the dose by 0.6 mg each week until the full maintenance dose of 3 mg is reached
  arm group label: metformin
  arm group type: Active Comparator
  description: the patient is given Glucophage 1000 mg tab once daily after lunch for 1month
  arm group label: control
  arm group type: No Intervention
  description: not given any drug
  intervention type: Drug
  intervention name: liraglutide
  description: glucagon-like peptide 1 receptor agonist
  arm group label: liraglutide
  other name: saxenda ampoules
  intervention type: Drug
  intervention name: Metformin
  description: biguanide antihyperglycemic
  arm group label: metformin
  other name: Glucophage 1000mg
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Beni-Suef University
  role: Study Director
  affiliation: Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
  last name: Sara A Salem, MD
  phone: 01272842226
  phone ext: 02
  email: sara_abdallah100@yahoo.com
  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: Metformin
  mesh term: Liraglutide
  sharing ipd: Yes
  ipd description: all collected data
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)