<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/NCT01679795</url>
  </required_header>
  <id_info>
    <org_study_id>TDILA</org_study_id>
    <nct_id>NCT01679795</nct_id>
  </id_info>
  <brief_title>Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Minas Gerais</source>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the vascular effects of tibolone on climateric women&#xD;
      measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound&#xD;
      and compare to placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery</measure>
    <time_frame>30 days</time_frame>
    <description>Flow-mediated dilation will be measured by high resolution ultrasound</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Flow-mediated Dilation Evaluation of the Brachial Artery</condition>
  <arm_group>
    <arm_group_label>Tibolone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patientes will use tibolone 2,5mg/day during 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo use</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will use placebo for 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tibolone</intervention_name>
    <arm_group_label>Tibolone</arm_group_label>
    <other_name>Livial</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo use</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women without menstrual cycles whithin the last 12 months and FSH&gt;30IU/L&#xD;
&#xD;
          -  Healthy women&#xD;
&#xD;
          -  Women that were not using drugs with potential vascular effect whithin the last 1 year&#xD;
&#xD;
          -  Women that never used hormone replacement therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Blood Pressure &gt; 160/90 mm Hg.&#xD;
&#xD;
          -  Breast and or endometrial cancer&#xD;
&#xD;
          -  History of acute myocardial infarction&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Vaginal bleeding of any origin&#xD;
&#xD;
          -  Hepatic disease&#xD;
&#xD;
          -  thrombophlebitis or thromboembolic disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>hospital das Clinicas - Universidade Federal de Minas Gerais</name>
      <address>
        <city>belo Horizonte</city>
        <state>minas Gerais</state>
        <zip>30130100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>April 2, 2015</last_update_submitted>
  <last_update_submitted_qc>April 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
    <investigator_full_name>Selmo Geber</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dilatation, Pathologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tibolone</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/NCT01679795
org study id: TDILA
nct id: NCT01679795
lead sponsor: 
The aim of this study is to evaluate the vascular effects of tibolone on climateric women
      measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound
      and compare to placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery
time frame: 30 days
description: Flow-mediated dilation will be measured by high resolution ultrasound
arm group label: Tibolone
arm group type: Experimental
description: patientes will use tibolone 2,5mg/day during 30 days
arm group label: Placebo use
arm group type: Placebo Comparator
description: Patients will use placebo for 30 days
intervention type: Drug
intervention name: Tibolone
arm group label: Tibolone
other name: Livial
intervention type: Drug
intervention name: Placebo
arm group label: Placebo use
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Minas Gerais
investigator full name: Selmo Geber
investigator title: Associate Professor
mesh term: Dilatation, Pathologic
mesh term: Tibolone