<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/NCT01731132</url>
  </required_header>
  <id_info>
    <org_study_id>16341</org_study_id>
    <secondary_id>MA1213ES</secondary_id>
    <secondary_id>BAY-DIU-2011-01</secondary_id>
    <nct_id>NCT01731132</nct_id>
  </id_info>
  <brief_title>DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.</brief_title>
  <acronym>DIUQoL</acronym>
  <official_title>DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Knowledge about the impact on quality of life of women initiating IUD in the Spanish&#xD;
      population at baseline and after 12 months of use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.</measure>
    <time_frame>After 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">207</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levonorgestrel IUD or Copper IUD</intervention_name>
    <description>Women who initiate the use of an IUD at the time of the study.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women who starts contraception with an IUD.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-49 years old female.&#xD;
&#xD;
          -  Women who is visited by a gynecology or primary care physician and starts&#xD;
             contraception with an IUD/IUS.&#xD;
&#xD;
          -  Women that has not used hormonal contraception in any form in the last 3 months.&#xD;
&#xD;
          -  Women who have no problems listening, reading or writing.&#xD;
&#xD;
          -  Women who gives their written consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who have contraindications to use IUDs.&#xD;
&#xD;
          -  Women with previous experience with IUDs.&#xD;
&#xD;
          -  Women who initiates the use of IUDs for other purposes other than contraception.&#xD;
&#xD;
          -  Woman who is participating in a clinical trial at the time of initiating the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Many Locations</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>July 15, 2015</last_update_submitted>
  <last_update_submitted_qc>July 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HRQoL</keyword>
  <keyword>IUD</keyword>
  <keyword>Contraception</keyword>
  <keyword>SEC-QoL</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Copper</mesh_term>
    <mesh_term>Levonorgestrel</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/NCT01731132
org study id: 16341
secondary id: MA1213ES
secondary id: BAY-DIU-2011-01
nct id: NCT01731132
lead sponsor: 
has dmc: No
Knowledge about the impact on quality of life of women initiating IUD in the Spanish
      population at baseline and after 12 months of use.
observational model: Cohort
time perspective: Prospective
measure: Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.
time frame: After 12 months
measure: Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.
time frame: Baseline
arm group label: Group 1
intervention type: Drug
intervention name: Levonorgestrel IUD or Copper IUD
description: Women who initiate the use of an IUD at the time of the study.
arm group label: Group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Copper
mesh term: Levonorgestrel