<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/NCT03229057</url>
  </required_header>
  <id_info>
    <org_study_id>827819</org_study_id>
    <secondary_id>5R01HD091350-05</secondary_id>
    <nct_id>NCT03229057</nct_id>
  </id_info>
  <brief_title>Comparing the Effects of Oral Contraceptive Pills Versus Metformin</brief_title>
  <acronym>COMET-PCOS</acronym>
  <official_title>Comparing the Effects of Oral Contraceptive Pills Versus Metformin in the Medical Management of Overweight/Obese Women With Polycystic Ovary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anuja Dokras</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the effect of Oral Contraceptive Pills (OCP) verses Metformin verses OCP and&#xD;
      Metformin on the prevalence of Metabolic Syndrome (MetS) and its components in&#xD;
      overweight/obese women with Polycystic Ovary Syndrome (PCOS).&#xD;
&#xD;
      The combination of OCP and metformin (OCP, through lowering androgens, and metformin, through&#xD;
      improvement in insulin sensitivity) will affect the prevalence of MetS, thereby altering the&#xD;
      risk profile for the development of diabetes and possible cardiovascular disease (CVD) in&#xD;
      young women with PCOS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention will consist of randomizing subjects to one of three arms. Subjects will&#xD;
      either be assigned to OCP + Placebo, Metformin + Placebo or OCP + Metformin. Metformin will&#xD;
      be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses.&#xD;
      Extended release pills will be utilized as they are associated with fewer gastrointestinal&#xD;
      side effects. Subjects will begin with one tablet of metformin every night for 5 days,&#xD;
      eventually building up to 4 tablets every night, with the maximum dose of metformin being&#xD;
      2000 mg. In regards to OCP, previous randomized clinical trials (RCTs) have shown that 20mcg&#xD;
      ethinyl estradiol/norethindrone 1.0 mg was well tolerated. The study will utilize a 20mcg OCP&#xD;
      but a less androgenic third generation progestin (desogestrel 0.15mg) with potentially lesser&#xD;
      impact on lipids and insulin sensitivity. The OCP will be started on the first Sunday after&#xD;
      spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization&#xD;
      will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce&#xD;
      menses). Placebo pills will be administered to individuals randomized to OCP or metformin&#xD;
      only in order to maintain study blinding. Subjects will undergo 6 in person study visits and&#xD;
      life style modification counseling regarding diet and exercise. Phone contact will be made 2&#xD;
      weeks after randomization and at the end of each month when there is no in person visit to&#xD;
      ensure study compliance with medications, keeping study logs and to review side effects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 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>
    <intervention_model_description>This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits. No longer term follow-up is planned.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of metabolic syndrome after randomizing to low dose OCP, metformin or OCP+metformin for 6 months.</measure>
    <time_frame>6 months</time_frame>
    <description>Our primary goal is to determine the effect of 6 months' treatment with OCP vs. metformin vs. OCP + metformin on prevalence of MetS and its components in overweight / obese women. Implicit in the primary aim is clearly defining MetS, by NCEP ATPIII criteria as the presence of at least 3 of the following 5 criteria: TG≥150mg/dl, HDL-C&lt;50mg/dl, BP≥130/≥85mmHg, WC&gt;88cm and fasting glucose≥100mg/dl; and the goal of tracking safety of our interventions at all Phases of the study (through safety lab evaluations, vital signs and diaries)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HDL-C function</measure>
    <time_frame>6 months</time_frame>
    <description>This will be assessed by measuring reverse cholesterol efflux capacity using validated ex vivo system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum apoliproteins</measure>
    <time_frame>6 months</time_frame>
    <description>This will be measured by NMR spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum adipokines in the 3 arms</measure>
    <time_frame>6 months</time_frame>
    <description>Serum adipokines to be measured are adiponectin and leptin. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in total and visceral body fat distribution in the 3 arms</measure>
    <time_frame>6 months</time_frame>
    <description>Body fat distribution will be measured by DXA. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in lipid particle size and number</measure>
    <time_frame>6 months</time_frame>
    <description>This will be measured by NMR spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum markers of inflammation and free fatty acids.</measure>
    <time_frame>6 months</time_frame>
    <description>Markers of inflammation to be measured are hsCRP, TNF α and IL6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life parameters in all 3 arms as assessed by PCOSQ</measure>
    <time_frame>6 months</time_frame>
    <description>QOL will be measured by the Polycystic Ovary Syndrome Questionnaire (PCOSQ)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>PCOS</condition>
  <arm_group>
    <arm_group_label>OCP + Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metformin + Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OCP + Metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OCP + Metformin</intervention_name>
    <description>This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.</description>
    <arm_group_label>OCP + Metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OCP + Placebo</intervention_name>
    <description>This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.</description>
    <arm_group_label>OCP + Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin + Placebo</intervention_name>
    <description>This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.</description>
    <arm_group_label>Metformin + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women ≥ 18 to ≤ 40 years of age (at the time of screening), with hyperandrogenic PCOS.&#xD;
&#xD;
          2. Subjects will be diagnosed with PCOS defined by the most recent Rotterdam criteria&#xD;
             based on:&#xD;
&#xD;
               1. androgen excess (defined as an elevated serum T level or hirsutism, based on a&#xD;
                  Ferriman Gallwey score &gt; 8 (note: &gt; 2 for women of Asian descent)&#xD;
&#xD;
                  AND either:&#xD;
&#xD;
               2. history of chronic anovulation (8 or fewer periods per year)&#xD;
&#xD;
                  AND/OR&#xD;
&#xD;
               3. polycystic ovaries.&#xD;
&#xD;
          3. BMI ≥ 25 kg/m² to ≤ 48 kg/m² obtained at screening visit.&#xD;
&#xD;
          4. In good general health.&#xD;
&#xD;
          5. Willing to avoid pregnancy for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current pregnancy or desire of pregnancy during course of study&#xD;
&#xD;
          2. Currently breastfeeding&#xD;
&#xD;
          3. Known 21 hydroxylase deficiency&#xD;
&#xD;
          4. Untreated thyroid disease (TSH &lt;0.45 mlU/mL and &gt; 4.5 mlU/mL)&#xD;
&#xD;
          5. Untreated hyperprolactinemia (2 Levels&gt;30 ng/ml at least one week apart)&#xD;
&#xD;
          6. Type 1 or type 2 Diabetes Mellitus (elevated fasting serum glucose &gt;126mg/dL on two&#xD;
             occasions, poorly controlled diabetes (HgbA1C&gt;6.5%), currently receiving anti-diabetic&#xD;
             agents, or currently receiving metformin for treatment of diabetes&#xD;
&#xD;
          7. Liver disease (AST/ALT&gt;2 times normal or a total bilirubin &gt;2.5 mg/dL)&#xD;
&#xD;
          8. Renal disease (BUN&gt;30 mg/dL or serum creatinine &gt;1.4 mg/dL)&#xD;
&#xD;
          9. Anemia (hemoglobin &lt;10 mg/dL)&#xD;
&#xD;
         10. History of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident&#xD;
&#xD;
         11. Current history of alcohol abuse (&gt;14drinks/week)&#xD;
&#xD;
         12. Poorly controlled hypertension defined as average systolic blood pressure &gt;= 150 mm Hg&#xD;
             or average diastolic &gt;=100 mm Hg obtained on three measurements obtained 5 minutes&#xD;
             apart. If treated, average systolic blood pressure &gt;=140 mm Hg or average diastolic&#xD;
             &gt;=90 mm Hg&#xD;
&#xD;
         13. Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or&#xD;
             breast carcinoma&#xD;
&#xD;
         14. TG&gt;200mg/dl&#xD;
&#xD;
         15. Use of lipid lowering or weight loss agents (subjects may wash out from weight loss&#xD;
             agents)&#xD;
&#xD;
         16. Current use of oral contraceptives, depo progestin, or hormonal implants&#xD;
&#xD;
         17. Participation in any study of an investigational drug or device or biological agent&#xD;
             within 30 days&#xD;
&#xD;
         18. Suspected adrenal or ovarian tumor secreting androgens&#xD;
&#xD;
         19. Suspected Cushing's syndrome&#xD;
&#xD;
         20. Bariatric surgery procedure in the recent past (&lt;12 months)&#xD;
&#xD;
         21. Absolute contraindications to the use of hormonal contraceptives or metformin,&#xD;
&#xD;
        23. Subjects who are unable to comply with the study procedures, for instance due to mental&#xD;
        illness, substance abuse, or participation in other studies.&#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>Anuja Dokras, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State/ Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://pennhealth.com/fertility/</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://whcrc.upenn.edu/</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Anuja Dokras</investigator_full_name>
    <investigator_title>Professor of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</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/NCT03229057
org study id: 827819
secondary id: 5R01HD091350-05
nct id: NCT03229057
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To determine the effect of Oral Contraceptive Pills (OCP) verses Metformin verses OCP and
      Metformin on the prevalence of Metabolic Syndrome (MetS) and its components in
      overweight/obese women with Polycystic Ovary Syndrome (PCOS).

      The combination of OCP and metformin (OCP, through lowering androgens, and metformin, through
      improvement in insulin sensitivity) will affect the prevalence of MetS, thereby altering the
      risk profile for the development of diabetes and possible cardiovascular disease (CVD) in
      young women with PCOS.
The intervention will consist of randomizing subjects to one of three arms. Subjects will
      either be assigned to OCP + Placebo, Metformin + Placebo or OCP + Metformin. Metformin will
      be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses.
      Extended release pills will be utilized as they are associated with fewer gastrointestinal
      side effects. Subjects will begin with one tablet of metformin every night for 5 days,
      eventually building up to 4 tablets every night, with the maximum dose of metformin being
      2000 mg. In regards to OCP, previous randomized clinical trials (RCTs) have shown that 20mcg
      ethinyl estradiol/norethindrone 1.0 mg was well tolerated. The study will utilize a 20mcg OCP
      but a less androgenic third generation progestin (desogestrel 0.15mg) with potentially lesser
      impact on lipids and insulin sensitivity. The OCP will be started on the first Sunday after
      spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization
      will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce
      menses). Placebo pills will be administered to individuals randomized to OCP or metformin
      only in order to maintain study blinding. Subjects will undergo 6 in person study visits and
      life style modification counseling regarding diet and exercise. Phone contact will be made 2
      weeks after randomization and at the end of each month when there is no in person visit to
      ensure study compliance with medications, keeping study logs and to review side effects
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits. No longer term follow-up is planned.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Prevalence of metabolic syndrome after randomizing to low dose OCP, metformin or OCP+metformin for 6 months.
time frame: 6 months
description: Our primary goal is to determine the effect of 6 months' treatment with OCP vs. metformin vs. OCP + metformin on prevalence of MetS and its components in overweight / obese women. Implicit in the primary aim is clearly defining MetS, by NCEP ATPIII criteria as the presence of at least 3 of the following 5 criteria: TG≥150mg/dl, HDL-C<50mg/dl, BP≥130/≥85mmHg, WC>88cm and fasting glucose≥100mg/dl; and the goal of tracking safety of our interventions at all Phases of the study (through safety lab evaluations, vital signs and diaries)
measure: Change in HDL-C function
time frame: 6 months
description: This will be assessed by measuring reverse cholesterol efflux capacity using validated ex vivo system
measure: Changes in serum apoliproteins
time frame: 6 months
description: This will be measured by NMR spectroscopy
measure: Changes in serum adipokines in the 3 arms
time frame: 6 months
description: Serum adipokines to be measured are adiponectin and leptin. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity
measure: Changes in total and visceral body fat distribution in the 3 arms
time frame: 6 months
description: Body fat distribution will be measured by DXA. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity
measure: Changes in lipid particle size and number
time frame: 6 months
description: This will be measured by NMR spectroscopy
measure: Changes in serum markers of inflammation and free fatty acids.
time frame: 6 months
description: Markers of inflammation to be measured are hsCRP, TNF α and IL6
measure: Changes in quality of life parameters in all 3 arms as assessed by PCOSQ
time frame: 6 months
description: QOL will be measured by the Polycystic Ovary Syndrome Questionnaire (PCOSQ)
arm group label: OCP + Placebo
arm group type: Active Comparator
description: The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
arm group label: Metformin + Placebo
arm group type: Active Comparator
description: Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
arm group label: OCP + Metformin
arm group type: Experimental
description: The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.
intervention type: Drug
intervention name: OCP + Metformin
description: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
arm group label: OCP + Metformin
intervention type: Drug
intervention name: OCP + Placebo
description: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
arm group label: OCP + Placebo
intervention type: Drug
intervention name: Metformin + Placebo
description: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
arm group label: Metformin + Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Anuja Dokras, MD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
facility: 
country: United States
url: http://pennhealth.com/fertility/
description: Related Info
url: http://whcrc.upenn.edu/
description: Related Info
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Anuja Dokras
investigator title: Professor of Obstetrics and Gynecology
mesh term: Metformin
sharing ipd: No