<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/NCT03236740</url>
  </required_header>
  <id_info>
    <org_study_id>OG/2017/12</org_study_id>
    <nct_id>NCT03236740</nct_id>
  </id_info>
  <brief_title>OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS</brief_title>
  <official_title>Doppler Analysis of Ovarian Stromal Blood Flow Changes After Treatment With Metformin Versus Ethinylestradiol-cyproterone Acetate in Women With Polycystic Ovarian Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>S.C.B. Medical College and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>S.C.B. Medical College and Hospital</source>
  <oversight_info>
    <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>
      This study is undertaken to compare the effects of treatment with commonly used OCP&#xD;
      containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special&#xD;
      attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and&#xD;
      they will be correlated with changes in hormonal parameters post-treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">March 15, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</primary_completion_date>
  <phase>Phase 4</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>Changes in ovarian stromal blood flow by using Doppler</measure>
    <time_frame>6 months</time_frame>
    <description>By means of color and power Doppler flow imaging, color signals will be searched in the ovarian stroma away from the ovarian surface and not adjacent to the wall of a follicle. Areas of maximum color intensity, representing the greatest Doppler frequency shifts, will be chosen for pulsed Doppler examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in BMI as measured in kg/m2</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in hirsutism measured by Modified Ferriman and Gallwey scores</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in menstrual cycle pattern</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference (cm)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood level of luteinizing hormone [LH] (mIU/ml) and follicle stimulating hormone [FSH] (mIU/ml)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood level of Testosterone (nmol/L)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting serum insulin levels (mIU/L)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting serum glucose levels (mg/dL)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>PCOS</condition>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Metformin 500mg bid in morning and evening after meals to be taken for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OCP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>OCP containing 35 microgram ethinylestradiol and 2-milligram cyproterone acetate to taken from the first day of the menstruation, oral administration of one pill daily for 21 days consecutively, then discontinue using the pill for seven days, and on the eighth day, restart taking the pill. OCP to be taken for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethinyl Estradiol-cyprosterone acetate</intervention_name>
    <description>Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.</description>
    <arm_group_label>OCP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin Hydrochloride</intervention_name>
    <description>Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.</description>
    <arm_group_label>Metformin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women diagnosed with PCOS according to the Rotterdam criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or previous use of oral contraceptives, glucocorticoids, antiandrogens,&#xD;
             ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal&#xD;
             drugs.&#xD;
&#xD;
          -  Medical or surgical treatment of PCOS during the previous 3 months&#xD;
&#xD;
          -  Presence of other endocrinopathies; except treated hypothyroidism on stable&#xD;
             replacement doses of thyroid hormone&#xD;
&#xD;
          -  Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months)&#xD;
&#xD;
          -  Inability to understand the proposal of the study precluding effective informed&#xD;
             consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Priyadarshini Tripathy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SCB Medical College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SCB Medical College</name>
      <address>
        <city>Cuttack</city>
        <state>Orissa</state>
        <zip>753007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 29, 2017</study_first_submitted>
  <study_first_submitted_qc>July 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>March 17, 2018</last_update_submitted>
  <last_update_submitted_qc>March 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Ethinyl Estradiol</mesh_term>
    <mesh_term>Estradiol</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/NCT03236740
org study id: OG/2017/12
nct id: NCT03236740
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is undertaken to compare the effects of treatment with commonly used OCP
      containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special
      attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and
      they will be correlated with changes in hormonal parameters post-treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in ovarian stromal blood flow by using Doppler
time frame: 6 months
description: By means of color and power Doppler flow imaging, color signals will be searched in the ovarian stroma away from the ovarian surface and not adjacent to the wall of a follicle. Areas of maximum color intensity, representing the greatest Doppler frequency shifts, will be chosen for pulsed Doppler examination.
measure: Change in BMI as measured in kg/m2
time frame: 6 months
measure: Improvement in hirsutism measured by Modified Ferriman and Gallwey scores
time frame: 6 months
measure: Improvement in menstrual cycle pattern
time frame: 6 months
measure: Change in waist circumference (cm)
time frame: 6 months
measure: Change in blood level of luteinizing hormone [LH] (mIU/ml) and follicle stimulating hormone [FSH] (mIU/ml)
time frame: 6 months
measure: Change in blood level of Testosterone (nmol/L)
time frame: 6 months
measure: Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml)
time frame: 6 months
measure: Change in blood levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)
time frame: 6 months
measure: Changes in fasting serum insulin levels (mIU/L)
time frame: 6 months
measure: Changes in fasting serum glucose levels (mg/dL)
time frame: 6 months
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
time frame: 6 months
arm group label: Metformin
arm group type: Active Comparator
description: Metformin 500mg bid in morning and evening after meals to be taken for 6 months.
arm group label: OCP
arm group type: Active Comparator
description: OCP containing 35 microgram ethinylestradiol and 2-milligram cyproterone acetate to taken from the first day of the menstruation, oral administration of one pill daily for 21 days consecutively, then discontinue using the pill for seven days, and on the eighth day, restart taking the pill. OCP to be taken for 6 months.
intervention type: Drug
intervention name: Ethinyl Estradiol-cyprosterone acetate
description: Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.
arm group label: OCP
intervention type: Drug
intervention name: Metformin Hydrochloride
description: Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.
arm group label: Metformin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Priyadarshini Tripathy, MD
role: Principal Investigator
affiliation: SCB Medical College
facility: 
country: India
responsible party type: Sponsor
mesh term: Metformin
mesh term: Ethinyl Estradiol
mesh term: Estradiol