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/NCT05981742</url>
    </required_header>
    <id_info>
      <org_study_id>AR2023101</org_study_id>
      <nct_id>NCT05981742</nct_id>
    </id_info>
    <brief_title>Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS</brief_title>
    <official_title>Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Rasheed University College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Rasheed University College</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this interventional Randomized clinical is to compare the effect of Metformin&#xD;
        alone, Cabergoline alone and Metformin and Cabergoline in combination in a sample of Iraqi&#xD;
        female patients with polycystic ovary syndrome. The main questions to answer are:&#xD;
  &#xD;
          1. What are the effects of the tested regimens on Body mass index (BMI)?&#xD;
  &#xD;
          2. What are the effects of the tested regimens on hormonal status?&#xD;
  &#xD;
          3. What are the effects of the tested regimens on uterine artery resistive index ?&#xD;
  &#xD;
          4. What are the effects of the tested regimens on some inflammatory markers?&#xD;
  &#xD;
        Participants will be separated into two groups:&#xD;
  &#xD;
          1. Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days&#xD;
             duration.&#xD;
  &#xD;
          2. Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose&#xD;
             per/week).&#xD;
  &#xD;
          3. Group 3 (MD): 25 Pateins, Received metformin 500 mg per oral twice daily for 90 days&#xD;
             duration and Dostinex (Pergolin) as 0.5 mg per oral (single dose per/week).&#xD;
  &#xD;
        Researchers will compare Group 1 (M), Group 2 (D), Group 3 (MD) to observe the effect of the&#xD;
        tested treatment regimens on Body Mass Index, Hormonal status, uterine artery resistive&#xD;
        index, and some inflammatory markers that are IL-18, Anti-GAD Antibody and GnRH Antibody.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 21, 2022</start_date>
    <completion_date type="Actual">March 31, 2023</completion_date>
    <primary_completion_date type="Actual">March 31, 2023</primary_completion_date>
    <phase>Phase 2</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 Mass Index (BMI)</measure>
      <time_frame>at Baseline, and after 90 days</time_frame>
      <description>Measured in Kg/m² as a part of hormone status changes analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum Anti-Müllerian hormone (AMH)</measure>
      <time_frame>at Baseline, and after 90 days</time_frame>
      <description>Measured in ng/mL as a part of hormone status changes analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum Testosterone</measure>
      <time_frame>at Baseline, and after 90 days</time_frame>
      <description>Measured in ng/mL as a part of hormone status changes analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum Luteinizing hormone (LH)</measure>
      <time_frame>at Baseline, and after 90 days</time_frame>
      <description>Measured in mIU/mL as a part of hormone status changes analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum Follicular Stimulating Hormone (FSH)</measure>
      <time_frame>at Baseline, and after 90 days</time_frame>
      <description>Measured in mIU/mL as a part of hormone status changes analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum Prolactin (PRL)</measure>
      <time_frame>at Baseline, and after 90 days</time_frame>
      <description>Measured in ng/mL as a part of hormone status changes analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean number of dominant follicles (DF)</measure>
      <time_frame>at Baseline, and after 90 days</time_frame>
      <description>Calculated by ultrasonography as a part of the ultrasonic analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean Resistive Index (RI)</measure>
      <time_frame>at Baseline, and after 90 days</time_frame>
      <description>Calculated by ultrasonography as a part of the ultrasonic analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum Anti-GAD antibody</measure>
      <time_frame>at Baseline, and after 90 days</time_frame>
      <description>Measured in ng/mL as a part of inflammatory markers analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum Anti-GnRH antibody</measure>
      <time_frame>at Baseline, and after 90 days</time_frame>
      <description>Measured in pg/mL as a part of inflammatory markers analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum IL-18 Level</measure>
      <time_frame>at Baseline, and after 90 days</time_frame>
      <description>Measured in pg/mL as a part of inflammatory markers analysis</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">75</enrollment>
    <condition>Polycystic Ovary Syndrome</condition>
    <arm_group>
      <arm_group_label>Group 1 (M)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 (D)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3 (MD)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily and Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Metformin Hydrochloride 500 MG</intervention_name>
      <description>Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration</description>
      <arm_group_label>Group 1 (M)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cabergoline 0.5 MG</intervention_name>
      <description>Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration</description>
      <arm_group_label>Group 2 (D)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG</intervention_name>
      <description>Metformin Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration&#xD;
  Cabergoline Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration</description>
      <arm_group_label>Group 3 (MD)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 - 40 years&#xD;
  &#xD;
            -  Diagnosed with Polycystic Ovarian Syndrome based on Rotterdam criteria&#xD;
  &#xD;
            -  Body Mass Index (BMI) &lt; 40 Kg/m²&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age less than 18 years or more than 40 years&#xD;
  &#xD;
            -  Co-morbid conditions including (diabetes mellitus, essential hypertension, and thyroid&#xD;
               disease)&#xD;
  &#xD;
            -  Patients planning for conception.&#xD;
  &#xD;
            -  Body Mass Index &gt; 40 Kg/m²&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Inas Naser Hamad, B.Sc. Pharmacy</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Al-Qadisiyah</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sinaa Abdul Amir Kadhim, Ph.D Pharmacology</last_name>
      <role>Study Director</role>
      <affiliation>University of Al-Qadisiyah</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hayder Adnan Fawzi, Ph.D Clinical Pharmacy</last_name>
      <role>Study Chair</role>
      <affiliation>Al-Mustafa University College</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Maternity and Pediatric Teaching Hospital</name>
        <address>
          <city>Al Qādisīyah</city>
          <state>Al-Qādisiyyah Governorate</state>
          <zip>58001</zip>
          <country>Iraq</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Rasheed University College</investigator_affiliation>
      <investigator_full_name>Hayder Adnan Fawzi</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>polycystic ovary syndrom</keyword>
    <keyword>hormones</keyword>
    <keyword>endometrial resistive index</keyword>
    <keyword>metformin</keyword>
    <keyword>Cabergoline</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>Cabergoline</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05981742
  org study id: AR2023101
  nct id: NCT05981742
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this interventional Randomized clinical is to compare the effect of Metformin
        alone, Cabergoline alone and Metformin and Cabergoline in combination in a sample of Iraqi
        female patients with polycystic ovary syndrome. The main questions to answer are:
  
          1. What are the effects of the tested regimens on Body mass index (BMI)?
  
          2. What are the effects of the tested regimens on hormonal status?
  
          3. What are the effects of the tested regimens on uterine artery resistive index ?
  
          4. What are the effects of the tested regimens on some inflammatory markers?
  
        Participants will be separated into two groups:
  
          1. Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days
             duration.
  
          2. Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose
             per/week).
  
          3. Group 3 (MD): 25 Pateins, Received metformin 500 mg per oral twice daily for 90 days
             duration and Dostinex (Pergolin) as 0.5 mg per oral (single dose per/week).
  
        Researchers will compare Group 1 (M), Group 2 (D), Group 3 (MD) to observe the effect of the
        tested treatment regimens on Body Mass Index, Hormonal status, uterine artery resistive
        index, and some inflammatory markers that are IL-18, Anti-GAD Antibody and GnRH Antibody.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Body Mass Index (BMI)
  time frame: at Baseline, and after 90 days
  description: Measured in Kg/m² as a part of hormone status changes analysis
  measure: Serum Anti-Müllerian hormone (AMH)
  time frame: at Baseline, and after 90 days
  description: Measured in ng/mL as a part of hormone status changes analysis
  measure: Serum Testosterone
  time frame: at Baseline, and after 90 days
  description: Measured in ng/mL as a part of hormone status changes analysis
  measure: Serum Luteinizing hormone (LH)
  time frame: at Baseline, and after 90 days
  description: Measured in mIU/mL as a part of hormone status changes analysis
  measure: Serum Follicular Stimulating Hormone (FSH)
  time frame: at Baseline, and after 90 days
  description: Measured in mIU/mL as a part of hormone status changes analysis
  measure: Serum Prolactin (PRL)
  time frame: at Baseline, and after 90 days
  description: Measured in ng/mL as a part of hormone status changes analysis
  measure: Mean number of dominant follicles (DF)
  time frame: at Baseline, and after 90 days
  description: Calculated by ultrasonography as a part of the ultrasonic analysis
  measure: Mean Resistive Index (RI)
  time frame: at Baseline, and after 90 days
  description: Calculated by ultrasonography as a part of the ultrasonic analysis
  measure: Serum Anti-GAD antibody
  time frame: at Baseline, and after 90 days
  description: Measured in ng/mL as a part of inflammatory markers analysis
  measure: Serum Anti-GnRH antibody
  time frame: at Baseline, and after 90 days
  description: Measured in pg/mL as a part of inflammatory markers analysis
  measure: Serum IL-18 Level
  time frame: at Baseline, and after 90 days
  description: Measured in pg/mL as a part of inflammatory markers analysis
  arm group label: Group 1 (M)
  arm group type: Active Comparator
  description: 25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration.
  arm group label: Group 2 (D)
  arm group type: Active Comparator
  description: 25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.
  arm group label: Group 3 (MD)
  arm group type: Active Comparator
  description: 25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily and Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.
  intervention type: Drug
  intervention name: Metformin Hydrochloride 500 MG
  description: Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration
  arm group label: Group 1 (M)
  intervention type: Drug
  intervention name: Cabergoline 0.5 MG
  description: Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration
  arm group label: Group 2 (D)
  intervention type: Drug
  intervention name: Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG
  description: Metformin Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration
  Cabergoline Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration
  arm group label: Group 3 (MD)
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Inas Naser Hamad, B.Sc. Pharmacy
  role: Principal Investigator
  affiliation: University of Al-Qadisiyah
  last name: Sinaa Abdul Amir Kadhim, Ph.D Pharmacology
  role: Study Director
  affiliation: University of Al-Qadisiyah
  last name: Hayder Adnan Fawzi, Ph.D Clinical Pharmacy
  role: Study Chair
  affiliation: Al-Mustafa University College
  facility: 
  country: Iraq
  responsible party type: Principal Investigator
  investigator affiliation: Al-Rasheed University College
  investigator full name: Hayder Adnan Fawzi
  investigator title: Associate Professor
  mesh term: Polycystic Ovary Syndrome
  mesh term: Metformin
  mesh term: Cabergoline