<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/NCT03305120</url>
  </required_header>
  <id_info>
    <org_study_id>ENDOMETRI-OS</org_study_id>
    <nct_id>NCT03305120</nct_id>
  </id_info>
  <brief_title>Musculo-scrawny Manifestation Associated With the Endometriosis</brief_title>
  <official_title>Musculo-scrawny Manifestation Associated With the Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The endometriosis is defined by the presence of endometriosic tissue outside of the womb and&#xD;
      the prevalence is estimated to be 10% of women.Here is a project aimed to compare&#xD;
      musculo-scrawny pains between patients with endometriosis and whose don't suffer of this&#xD;
      pathology;&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2016</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">October 16, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>VAS of musculo-scrawny pain</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <enrollment type="Actual">41</enrollment>
  <condition>Endometriosis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pain VAS evaluation</intervention_name>
    <description>each patient has to answer to a questionnaire about pain</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient consulting in gynecologic service of GHPSJ&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 45&#xD;
&#xD;
          -  consulting in Service of gynecology&#xD;
&#xD;
          -  First trimester of pregnancy or for pap smears&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  endometriosis diagnostic already done&#xD;
&#xD;
          -  rhumalogic disease known&#xD;
&#xD;
          -  age &lt; 18 and &gt; 50&#xD;
&#xD;
          -  menopause&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>only women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</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/NCT03305120
org study id: ENDOMETRI-OS
nct id: NCT03305120
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The endometriosis is defined by the presence of endometriosic tissue outside of the womb and
      the prevalence is estimated to be 10% of women.Here is a project aimed to compare
      musculo-scrawny pains between patients with endometriosis and whose don't suffer of this
      pathology;
observational model: Case-Control
time perspective: Prospective
measure: VAS of musculo-scrawny pain
time frame: Day 1
intervention type: Other
intervention name: pain VAS evaluation
description: each patient has to answer to a questionnaire about pain
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: only women
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Endometriosis