<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/NCT02195609</url>
  </required_header>
  <id_info>
    <org_study_id>IP-2013-01</org_study_id>
    <nct_id>NCT02195609</nct_id>
  </id_info>
  <brief_title>Evaluate the Effect of Omega-3 vs Soy Isoflavones in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms</brief_title>
  <acronym>OMEGASI</acronym>
  <official_title>Randomized Open Label Study to Evaluate the Effect of (Omega-3) EPA + Docosahexaenoic Acid (DHA) vs Soy Isoflavones in 100 Postmenopausal Women Between 45-65 Years With Moderate to Severe Vasomotor Symptoms.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Palacios</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ferrer Internacional S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Palacios</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women&#xD;
      treated for 4 months with Omega-3 vs Soy Isoflavones.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a non-inferiority study of Omega 3 versus Soy Isoflavones, being each patient its own&#xD;
      control from the baseline.&#xD;
&#xD;
      In order to determine the difference observed in the evolution of intensity, frequency and&#xD;
      the total number of hot flashes in 4 months in patients treated with Omega-3 vs Soy&#xD;
      Isoflavones, is planned to include at least 100 patients, 50 per treatment arm.&#xD;
&#xD;
      It si estimated a standar deviation of 0.5%, and a 10% lost follow-up rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the changes in vasomotor symptoms.</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>To evaluate the changes in vasomotor symptoms in postmenopausal women measured by a hot flushes self-completed diary .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk factors</measure>
    <time_frame>0 and 4 months</time_frame>
    <description>serum cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with treatment</measure>
    <time_frame>at month 1 and 4</time_frame>
    <description>Treatment Satisfaction Questionnaire for Medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood status</measure>
    <time_frame>0, 1 and 4 months</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General health status</measure>
    <time_frame>months 0, 1 and 4</time_frame>
    <description>General health status by Short-Form 36 (SF-36) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rating memory status</measure>
    <time_frame>at 0, 1 and 4 months</time_frame>
    <description>Alteration of the memory test (T@M)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk factors</measure>
    <time_frame>0 amd 4 months</time_frame>
    <description>serum triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk factors</measure>
    <time_frame>0, 1 and 4 months</time_frame>
    <description>Blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk factors</measure>
    <time_frame>0, 1 and 4 months</time_frame>
    <description>Body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk factors</measure>
    <time_frame>0, 1 and 4 months</time_frame>
    <description>abdominal circumference</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Menopause</condition>
  <condition>Hot Flashes</condition>
  <arm_group>
    <arm_group_label>Omega-3</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>600 mg (EPA, DHA and Omega-3) twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Soy Isoflavones</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>54.4mg oral twice a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3</intervention_name>
    <description>600 mg oral twice a day</description>
    <arm_group_label>Omega-3</arm_group_label>
    <other_name>Om3gafort</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Soy Isoflavones</intervention_name>
    <description>54.4 mg oral twice a day</description>
    <arm_group_label>Soy Isoflavones</arm_group_label>
    <other_name>Flavia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ambulatory and can complete all study procedures, which are able to read, understand&#xD;
             and sign an informed consent and willing to come to the center for study visits.&#xD;
&#xD;
          -  Postmenopausal (≥ 1 year of amenorrhea) or 6 months or more of amenorrhea with&#xD;
             follicle stimulating hormone (FSH) ≥ 40 IU / L.&#xD;
&#xD;
          -  BMI ≥ 18 kg/m2 and ≤ 30 kg/m2&#xD;
&#xD;
          -  Flushing of moderate to severe intensity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with surgical menopause.&#xD;
&#xD;
          -  Treatment with hormone replacement therapy (HRT) in the 3 months prior to inclusion&#xD;
&#xD;
          -  Uterine bleeding after menopause with undetermined cause in the 12 months prior to&#xD;
             screening.&#xD;
&#xD;
          -  Presence or history of malignancy in the past 5 years.&#xD;
&#xD;
          -  Malabsorption syndrome.&#xD;
&#xD;
          -  Hype or uncontrolled hypothyroidism.&#xD;
&#xD;
          -  Dyslipidemia (LDL-cholesterol&gt; 189 mg / dl or medical criteria) requiring an specific&#xD;
             treatment of proven effectiveness.&#xD;
&#xD;
          -  Chronic renal disease.&#xD;
&#xD;
          -  Uncontrolled or untreated hypertension.&#xD;
&#xD;
          -  Treatment with isoflavones, tibolone, Selective Estrogen Receptors Moderators (SERM´s)&#xD;
             in the past 3 months prior to the testing selection period.&#xD;
&#xD;
          -  Hormonal treatment with androgens, estrogens, progestins, alone or combined oral,&#xD;
             transdermal, vaginal (including promestriene) or implant, in the last 3 months prior&#xD;
             to testing selection period.&#xD;
&#xD;
          -  Patients who receive or require treatment with antidepressants or anticonvulsants&#xD;
&#xD;
          -  Patients with mental illness.&#xD;
&#xD;
          -  History of noncompliance with taking medication.&#xD;
&#xD;
          -  Suspected or abuse of alcohol or other drugs during the 12 months preceding the&#xD;
             selection.&#xD;
&#xD;
          -  Use of any experimental drug or device within 30 days prior to the selection.&#xD;
&#xD;
          -  Any other condition or finding that a judgment of the investigator may jeopardise the&#xD;
             tral conduct according to the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Santiago Palacios, MD</last_name>
    <role>Study Director</role>
    <affiliation>President of the European Foundation Woman and Health,Past President and Honorary Member of the Spanish Menopause Society, President of the Council of Affiliated Menopause Societies (CAMS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Palacios</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>September 15, 2016</last_update_submitted>
  <last_update_submitted_qc>September 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vasomotor Symptoms Associated With Menopause</keyword>
  <keyword>Menopause</keyword>
  <keyword>Hot Flashes</keyword>
  <keyword>Postmenopausal Women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02195609
org study id: IP-2013-01
nct id: NCT02195609
lead sponsor: 
collaborator: 
has dmc: Yes
This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women
      treated for 4 months with Omega-3 vs Soy Isoflavones.
This is a non-inferiority study of Omega 3 versus Soy Isoflavones, being each patient its own
      control from the baseline.

      In order to determine the difference observed in the evolution of intensity, frequency and
      the total number of hot flashes in 4 months in patients treated with Omega-3 vs Soy
      Isoflavones, is planned to include at least 100 patients, 50 per treatment arm.

      It si estimated a standar deviation of 0.5%, and a 10% lost follow-up rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Evaluate the changes in vasomotor symptoms.
time frame: 0 to 4 months
description: To evaluate the changes in vasomotor symptoms in postmenopausal women measured by a hot flushes self-completed diary .
measure: Cardiovascular risk factors
time frame: 0 and 4 months
description: serum cholesterol
measure: Satisfaction with treatment
time frame: at month 1 and 4
description: Treatment Satisfaction Questionnaire for Medication
measure: Mood status
time frame: 0, 1 and 4 months
description: Hospital Anxiety and Depression Scale (HADS)
measure: General health status
time frame: months 0, 1 and 4
description: General health status by Short-Form 36 (SF-36) questionnaire
measure: Rating memory status
time frame: at 0, 1 and 4 months
description: Alteration of the memory test (T@M)
measure: Cardiovascular risk factors
time frame: 0 amd 4 months
description: serum triglycerides
measure: Cardiovascular risk factors
time frame: 0, 1 and 4 months
description: Blood pressure
measure: Cardiovascular risk factors
time frame: 0, 1 and 4 months
description: Body mass index
measure: Cardiovascular risk factors
time frame: 0, 1 and 4 months
description: abdominal circumference
arm group label: Omega-3
arm group type: Other
description: 600 mg (EPA, DHA and Omega-3) twice a day
arm group label: Soy Isoflavones
arm group type: Other
description: 54.4mg oral twice a day
intervention type: Dietary Supplement
intervention name: Omega-3
description: 600 mg oral twice a day
arm group label: Omega-3
other name: Om3gafort
intervention type: Dietary Supplement
intervention name: Soy Isoflavones
description: 54.4 mg oral twice a day
arm group label: Soy Isoflavones
other name: Flavia
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Santiago Palacios, MD
role: Study Director
affiliation: President of the European Foundation Woman and Health,Past President and Honorary Member of the Spanish Menopause Society, President of the Council of Affiliated Menopause Societies (CAMS)
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Hot Flashes