<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/NCT01720459</url>
  </required_header>
  <id_info>
    <org_study_id>681/10</org_study_id>
    <nct_id>NCT01720459</nct_id>
  </id_info>
  <brief_title>Effects of Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients</brief_title>
  <official_title>Effects of Micronized Trans-resveratrol Treatment on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Placebo-controlled Randomized Single-blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poznan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Poznan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether micronized trans-resveratrol improves&#xD;
      clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids,&#xD;
      markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>testosterone serum concentration</measure>
    <time_frame>3 month therapy</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Polycystic Ovary Syndrome (PCOS)</condition>
  <arm_group>
    <arm_group_label>Micronized trans-resveratrol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Micronized trans-resveratrol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Micronized trans-resveratrol</intervention_name>
    <arm_group_label>Micronized trans-resveratrol</arm_group_label>
    <other_name>Micronized trans-resveratrol 500 (Rev Genetics LLC - Miami, FL, USA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PCO - Androgen Excess Society criteria: hyperandrogenism (hirsutism) /&#xD;
             hyperandrogenemia (testosterone &gt;70ng/dl) and/or oligomenorrhea (&lt;8 spontaneous menses&#xD;
             per year) and/or polycystic ovarian morphology on ultrasound&#xD;
&#xD;
          -  Normal prolactin, TSH, 17-OH progesterone&#xD;
&#xD;
          -  No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly&#xD;
&#xD;
          -  Age 18-40&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of oral contraceptives and/or other steroid hormones 3 months prior to the 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>Leszek A Pawelczyk, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Poznan University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antoni J Duleba, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Beata Banaszewska, MD PhD</last_name>
    <phone>+48 61 8419412</phone>
    <email>bbeata48@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert Z Spaczynski, MD PhD</last_name>
    <phone>+48 61 8419412</phone>
    <email>rspaczynski@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Poznan University of Medical Sciences</name>
      <address>
        <city>Poznan</city>
        <zip>60-535</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>November 1, 2012</last_update_submitted>
  <last_update_submitted_qc>November 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poznan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Beata Banaszewska</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Resveratrol</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/NCT01720459
org study id: 681/10
nct id: NCT01720459
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether micronized trans-resveratrol improves
      clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids,
      markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: testosterone serum concentration
time frame: 3 month therapy
arm group label: Micronized trans-resveratrol
arm group type: Active Comparator
description: Micronized trans-resveratrol
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Micronized trans-resveratrol
arm group label: Micronized trans-resveratrol
other name: Micronized trans-resveratrol 500 (Rev Genetics LLC - Miami, FL, USA)
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Leszek A Pawelczyk, MD PhD
role: Study Chair
affiliation: Poznan University of Medical Sciences
last name: Antoni J Duleba, MD
role: Study Director
affiliation: University of California, Davis
last name: Beata Banaszewska, MD PhD
phone: +48 61 8419412
email: bbeata48@gmail.com
last name: Robert Z Spaczynski, MD PhD
phone: +48 61 8419412
email: rspaczynski@yahoo.com
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Poznan University of Medical Sciences
investigator full name: Beata Banaszewska
investigator title: MD PhD
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
mesh term: Resveratrol