<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/NCT01723917</url>
  </required_header>
  <id_info>
    <org_study_id>AG033288</org_study_id>
    <secondary_id>R01AG033288</secondary_id>
    <nct_id>NCT01723917</nct_id>
  </id_info>
  <brief_title>Phytoserms for Menopause Symptoms and Age-Associated Memory Decline</brief_title>
  <acronym>phytoSERM</acronym>
  <official_title>Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of a soy based dietary&#xD;
      supplement (phytoSERM) for hot flashes and age associated memory loss.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>safety and tolerability</measure>
    <time_frame>12 weeks</time_frame>
    <description>as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>efficacy</measure>
    <time_frame>12 weeks</time_frame>
    <description>change from baseline in neuropsychological (cognitive, functional) test results</description>
  </primary_outcome>
  <primary_outcome>
    <measure>efficacy</measure>
    <time_frame>12 weeks</time_frame>
    <description>change from baseline in vasomotor symptoms</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Hot Flashes</condition>
  <condition>Memory Loss</condition>
  <arm_group>
    <arm_group_label>PhytoSERM 50 mg tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PhytoSERM 100 mg tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dietary supplement: placebo tablet to be taken once per day for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>PhytoSERM tablet</intervention_name>
    <arm_group_label>PhytoSERM 100 mg tablet</arm_group_label>
    <arm_group_label>PhytoSERM 50 mg tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  post-menopausal women&#xD;
&#xD;
          -  ages 45 - 60 (inclusive)&#xD;
&#xD;
          -  must have a vasomotor symptom (e.g., hot flash) and a memory complaint&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of clinically significant stroke&#xD;
&#xD;
          -  current evidence or history in past 2 years of epilepsy, seizure, focal brain lesion,&#xD;
             head injury with loss of consciousness or any major psychiatric disorder including&#xD;
             psychosis, major depression, bipolar disorder, alcohol or substance abuse&#xD;
&#xD;
          -  Known allergy to soy derived products; hypersensitivity to estrogens or progestins&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lon S Schneider, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC Keck School of Medicine</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Lon Schneider</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Memory Disorders</mesh_term>
    <mesh_term>Hot Flashes</mesh_term>
  </condition_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/NCT01723917
org study id: AG033288
secondary id: R01AG033288
nct id: NCT01723917
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the safety and efficacy of a soy based dietary
      supplement (phytoSERM) for hot flashes and age associated memory loss.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: safety and tolerability
time frame: 12 weeks
description: as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance
measure: efficacy
time frame: 12 weeks
description: change from baseline in neuropsychological (cognitive, functional) test results
measure: efficacy
time frame: 12 weeks
description: change from baseline in vasomotor symptoms
arm group label: PhytoSERM 50 mg tablet
arm group type: Experimental
description: Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
arm group label: PhytoSERM 100 mg tablet
arm group type: Experimental
description: Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
arm group label: Placebo tablet
arm group type: Placebo Comparator
description: Dietary supplement: placebo tablet to be taken once per day for 12 weeks
intervention type: Dietary Supplement
intervention name: PhytoSERM tablet
arm group label: PhytoSERM 100 mg tablet
arm group label: PhytoSERM 50 mg tablet
intervention type: Dietary Supplement
intervention name: placebo
arm group label: Placebo tablet
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 60 Years
healthy volunteers: No
last name: Lon S Schneider, MD
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Lon Schneider
investigator title: Professor
mesh term: Memory Disorders
mesh term: Hot Flashes