<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/NCT03757923</url>
  </required_header>
  <id_info>
    <org_study_id>DowUHS3</org_study_id>
    <nct_id>NCT03757923</nct_id>
  </id_info>
  <brief_title>Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism</brief_title>
  <acronym>mprmih</acronym>
  <official_title>Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dow University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dow University of Health Sciences</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>
      To compare metformin with pioglitazone in improving menstrual irregularities and&#xD;
      hyperandrogenism in women with PCOS so that an alternate and better treatment option will be&#xD;
      available for hyperinsulinemia in pcos patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a prospective, randomized, open label, multicentre study. It will be&#xD;
      carried out in outpatients department of Obstetrics and gynecology, at the Dow university of&#xD;
      Hospital and mamji hospital Karachi.&#xD;
&#xD;
      The study period will be of 6 months. Polycystic ovarian syndrome PCOS constitute most common&#xD;
      endocrinopathy present in 4-7% women of reproductive age. Rotterdam criteria, diagnosis of&#xD;
      PCOS require two of the three features: oligo and/or anovulation, clinical and/or biochemical&#xD;
      signs of hyperandrogenism and polycystic ovaries by u/s and the absence of other endocrine&#xD;
      conditions such as hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, or&#xD;
      hyperprolactinemia.&#xD;
&#xD;
      Insulin resistance and hyperinsulinemia may play a key role in pathogenesis of this syndrome&#xD;
      by deregulating LH secretion at central level and increased stimulation of cytochrome p450 in&#xD;
      ovary, hyperinsulinemia also decreases the circulating concentration of SHBG and contribute&#xD;
      to greater concentration of free androgens in blood, cut off of insulin level for insulin&#xD;
      resistance in Pakistani population is 9.25U/ml. On basis of evidence, Insulin sensitizing&#xD;
      agents has been recently proposed as a useful treatment option in women with pcos, which by&#xD;
      reducing insulin resistance and hyperinsulinemia, reduce the insulin driven ovarian and&#xD;
      adrenal hyperandrogenism usually restoring normal LH and FSH secretion and ovulatory cycles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 18, 2018</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">December 17, 2018</primary_completion_date>
  <phase>Phase 1/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>
    <intervention_model_description>randomized controlled trail</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HIRSUTISM</measure>
    <time_frame>3 months</time_frame>
    <description>Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>POLYCYSTIC OVARIES</measure>
    <time_frame>3 months</time_frame>
    <description>assessment on ultrasound (qualitative-present/not present)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MENSTRUAL IRREGULARITIES</measure>
    <time_frame>3 months</time_frame>
    <description>assessment on history(qualitative-present/not present)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>3 months</time_frame>
    <description>weight and height will be combined to report BMI in kg/m2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SERUM FASTING INSULIN</measure>
    <time_frame>3 months</time_frame>
    <description>unit of measure: uIU/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FASTING BLOOD SUGAR</measure>
    <time_frame>3 months</time_frame>
    <description>unit of measure:mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FREE TESTOSTERONE</measure>
    <time_frame>3 months</time_frame>
    <description>unit of measure :nmol/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FREE ANDROGEN INDEX</measure>
    <time_frame>3 months</time_frame>
    <description>numerical</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Menstrual Irregularities</condition>
  <condition>Hyperandrogenism</condition>
  <arm_group>
    <arm_group_label>metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAB METFORMIN 500mg TDS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pioglitazone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAB PIOGLITAZONE 30 mg OD</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAB METFORMIN</intervention_name>
    <description>INSULIN SENSITIZING AGENTS</description>
    <arm_group_label>metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAB PIOGLITAZONE</intervention_name>
    <description>INSULIN SENSITIZING AGENT</description>
    <arm_group_label>pioglitazone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. women of age 18-40 with primary or secondary infertility.&#xD;
&#xD;
          2. Polycystic ovarian syndrome daignosed using rotterdam criteria.&#xD;
&#xD;
          3. Not taken any medication before for PCOS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women having type 1 or type 2 diabetes mellitus.&#xD;
&#xD;
          2. Abnormal kidney or liver function.&#xD;
&#xD;
          3. Hypertension or heart disease.&#xD;
&#xD;
          4. Gonadotrophin induction or ovarian drilling before will not be included in this study.&#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>Bader F Zuberi, FCPS</last_name>
    <role>Study Director</role>
    <affiliation>Dow University of Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jahan A Ainuddin</last_name>
    <phone>03012530961</phone>
    <email>jahanaraainuddin@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dow University Hospital OJHA</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>75270</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dow University of Health Sciences</investigator_affiliation>
    <investigator_full_name>Jahan Ara Ainuddin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>PCO</keyword>
  <keyword>Metformin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperandrogenism</mesh_term>
    <mesh_term>Menstruation Disturbances</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Pioglitazone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03757923
org study id: DowUHS3
nct id: NCT03757923
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
To compare metformin with pioglitazone in improving menstrual irregularities and
      hyperandrogenism in women with PCOS so that an alternate and better treatment option will be
      available for hyperinsulinemia in pcos patients.
This study will be a prospective, randomized, open label, multicentre study. It will be
      carried out in outpatients department of Obstetrics and gynecology, at the Dow university of
      Hospital and mamji hospital Karachi.

      The study period will be of 6 months. Polycystic ovarian syndrome PCOS constitute most common
      endocrinopathy present in 4-7% women of reproductive age. Rotterdam criteria, diagnosis of
      PCOS require two of the three features: oligo and/or anovulation, clinical and/or biochemical
      signs of hyperandrogenism and polycystic ovaries by u/s and the absence of other endocrine
      conditions such as hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, or
      hyperprolactinemia.

      Insulin resistance and hyperinsulinemia may play a key role in pathogenesis of this syndrome
      by deregulating LH secretion at central level and increased stimulation of cytochrome p450 in
      ovary, hyperinsulinemia also decreases the circulating concentration of SHBG and contribute
      to greater concentration of free androgens in blood, cut off of insulin level for insulin
      resistance in Pakistani population is 9.25U/ml. On basis of evidence, Insulin sensitizing
      agents has been recently proposed as a useful treatment option in women with pcos, which by
      reducing insulin resistance and hyperinsulinemia, reduce the insulin driven ovarian and
      adrenal hyperandrogenism usually restoring normal LH and FSH secretion and ovulatory cycles.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled trail
primary purpose: Treatment
masking: None (Open Label)
measure: HIRSUTISM
time frame: 3 months
description: Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)
measure: POLYCYSTIC OVARIES
time frame: 3 months
description: assessment on ultrasound (qualitative-present/not present)
measure: MENSTRUAL IRREGULARITIES
time frame: 3 months
description: assessment on history(qualitative-present/not present)
measure: BMI
time frame: 3 months
description: weight and height will be combined to report BMI in kg/m2
measure: SERUM FASTING INSULIN
time frame: 3 months
description: unit of measure: uIU/ml
measure: FASTING BLOOD SUGAR
time frame: 3 months
description: unit of measure:mg/dl
measure: FREE TESTOSTERONE
time frame: 3 months
description: unit of measure :nmol/l
measure: FREE ANDROGEN INDEX
time frame: 3 months
description: numerical
arm group label: metformin
arm group type: Experimental
description: TAB METFORMIN 500mg TDS
arm group label: pioglitazone
arm group type: Experimental
description: TAB PIOGLITAZONE 30 mg OD
intervention type: Drug
intervention name: TAB METFORMIN
description: INSULIN SENSITIZING AGENTS
arm group label: metformin
intervention type: Drug
intervention name: TAB PIOGLITAZONE
description: INSULIN SENSITIZING AGENT
arm group label: pioglitazone
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Bader F Zuberi, FCPS
role: Study Director
affiliation: Dow University of Health Sciences
last name: Jahan A Ainuddin
phone: 03012530961
email: jahanaraainuddin@yahoo.com
facility: 
status: Recruiting
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Dow University of Health Sciences
investigator full name: Jahan Ara Ainuddin
investigator title: Professor
mesh term: Hyperandrogenism
mesh term: Menstruation Disturbances
mesh term: Metformin
mesh term: Pioglitazone
sharing ipd: No