<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/NCT03794895</url>
  </required_header>
  <id_info>
    <org_study_id>Yasmine's Protocol</org_study_id>
    <nct_id>NCT03794895</nct_id>
  </id_info>
  <brief_title>Prediction of Response to IUCD Associated Menorrhagia Using Doppler</brief_title>
  <official_title>Assessment of Efficacy of Uterine Artery Doppler in Predicting the Response to Mefenamic Acid During Treatment of Women With IUCD Associated Menorrhagia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in&#xD;
      women having IUCD associated menorrhagia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resistance index and Pulsitality index (Predicting the response to IUCD associated menorrhagia)</measure>
    <time_frame>1 year</time_frame>
    <description>Base line uterine artery doppler is done to the patient complaining of IUCD related menorrhagia prior to treatment , parameters of doppler are: resistance index and pulsitality index, then the patient takes mefenamic acid tablets 500 mg three times daily for five days, assessment of response whether the patient is responder or not is done using pictorial blood loss assessment chart then base line doppler parameters in responders and non responders are compared to correlate the response to base line doppler parameters</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Women's Health: Amenorrhea/Dysmenorrhea</condition>
  <arm_group>
    <arm_group_label>Single arm clinical trial</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Doppler</intervention_name>
    <description>Doing doppler for women having IUCD associated menorrhagia</description>
    <arm_group_label>Single arm clinical trial</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women in chile bearing period (age 20-35 yrs ) with history of regular menstrual cycle&#xD;
             presenting with recent onset of more then three months menorrhagia after IUCD &quot;copper&#xD;
             T 380 A&quot; insertion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of bleeding tendency&#xD;
&#xD;
          -  history of abnormal uterine bleeding due to other causes&#xD;
&#xD;
          -  history of active liver disease&#xD;
&#xD;
          -  history of antiplatelet or anticoagulant intake in the last month&#xD;
&#xD;
          -  history of thyroid disease&#xD;
&#xD;
          -  history of endometritis&#xD;
&#xD;
          -  history of allergy to NSAIDs&#xD;
&#xD;
          -  Adenomyosis&#xD;
&#xD;
          -  women having contraindications to use NSAIDs e.g. peptic ulcer&#xD;
&#xD;
          -  Insulin dependant diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female having menorrhagia due to IUCD</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yasmine Es Ismail, Bachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AinshamsU</name>
      <address>
        <city>Cairo</city>
        <state>Abbaseya</state>
        <zip>11511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Yasmine Essam Eldin Mohamed Mohamed Ismail</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menorrhagia</mesh_term>
    <mesh_term>Dysmenorrhea</mesh_term>
    <mesh_term>Amenorrhea</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/NCT03794895
org study id: Yasmine's Protocol
nct id: NCT03794895
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in
      women having IUCD associated menorrhagia
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Resistance index and Pulsitality index (Predicting the response to IUCD associated menorrhagia)
time frame: 1 year
description: Base line uterine artery doppler is done to the patient complaining of IUCD related menorrhagia prior to treatment , parameters of doppler are: resistance index and pulsitality index, then the patient takes mefenamic acid tablets 500 mg three times daily for five days, assessment of response whether the patient is responder or not is done using pictorial blood loss assessment chart then base line doppler parameters in responders and non responders are compared to correlate the response to base line doppler parameters
arm group label: Single arm clinical trial
arm group type: Experimental
intervention type: Device
intervention name: Doppler
description: Doing doppler for women having IUCD associated menorrhagia
arm group label: Single arm clinical trial
criteria: 
gender: Female
gender based: Yes
gender description: female having menorrhagia due to IUCD
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
last name: Yasmine Es Ismail, Bachelor
role: Principal Investigator
affiliation: Ain Shams University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Yasmine Essam Eldin Mohamed Mohamed Ismail
investigator title: Principal investigator
mesh term: Menorrhagia
mesh term: Dysmenorrhea
mesh term: Amenorrhea