<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/NCT03770169</url>
  </required_header>
  <id_info>
    <org_study_id>D-FR-52120-252</org_study_id>
    <nct_id>NCT03770169</nct_id>
  </id_info>
  <brief_title>Validation of Patient Reported Outcome Measures for Use in Vulvodynia</brief_title>
  <official_title>Validation of Patient Reported Outcome Measures for Use in Vulvodynia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ipsen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ipsen</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 overall aim of this project is to demonstrate content validity and usability of the&#xD;
      modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function&#xD;
      Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with&#xD;
      Vulvodynia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">September 19, 2019</completion_date>
  <primary_completion_date type="Actual">September 19, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validation of mVPAQ</measure>
    <time_frame>1 week</time_frame>
    <description>Cognitive debrief and usability through interviews and completion of an electronic diary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validation of mFSFI</measure>
    <time_frame>1 week</time_frame>
    <description>Cognitive debrief and usability through interviews and completion of an electronic diary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validation of Pain on Intercourse Numeric Rating Scale (NRS)</measure>
    <time_frame>1 week</time_frame>
    <description>Cognitive debrief and usability through interviews and completion of an electronic diary. Pain on Intercourse NRS that describes pain experienced during this sexual intercourse episode by number. The higher is the number the worse is pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vulvar pain NRS</measure>
    <time_frame>1 week</time_frame>
    <description>Assess understanding of the appropriateness of the vulvar pain NRS through interview and completion of an electronic diary</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Vulvodynia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects referred by clinicians&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fluent in understanding, speaking and reading US-English&#xD;
&#xD;
          -  Have vulvodynia with pain for at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant history of alcohol/drug abuse or dependence within the last 2&#xD;
             years&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ipsen Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Ipsen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Diego Sexual Medicine</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Vulvovaginal Disorders</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omaha OB-GYN Associates, PC</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Vulvovaginal Disorders</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>October 25, 2019</last_update_submitted>
  <last_update_submitted_qc>October 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2019</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>Vulvodynia</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/NCT03770169
org study id: D-FR-52120-252
nct id: NCT03770169
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall aim of this project is to demonstrate content validity and usability of the
      modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function
      Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with
      Vulvodynia
observational model: Case-Only
time perspective: Prospective
measure: Validation of mVPAQ
time frame: 1 week
description: Cognitive debrief and usability through interviews and completion of an electronic diary
measure: Validation of mFSFI
time frame: 1 week
description: Cognitive debrief and usability through interviews and completion of an electronic diary
measure: Validation of Pain on Intercourse Numeric Rating Scale (NRS)
time frame: 1 week
description: Cognitive debrief and usability through interviews and completion of an electronic diary. Pain on Intercourse NRS that describes pain experienced during this sexual intercourse episode by number. The higher is the number the worse is pain.
measure: Vulvar pain NRS
time frame: 1 week
description: Assess understanding of the appropriateness of the vulvar pain NRS through interview and completion of an electronic diary
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ipsen Medical Director
role: Study Director
affiliation: Ipsen
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vulvodynia