<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/NCT04500028</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/355/3/19</org_study_id>
    <nct_id>NCT04500028</nct_id>
  </id_info>
  <brief_title>Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System</brief_title>
  <official_title>Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double Blinded Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aswan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the&#xD;
      levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions,&#xD;
      insertion-related complications, and pain in Women With no Previous Vaginal Delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Long-acting reversible contraception methods are highly effective methods for reduction of&#xD;
      the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that&#xD;
      provides reliable, effective and long term contraception for many women. However, the&#xD;
      insertion procedure can be associated with a troublesome degree of pain that prevent some&#xD;
      women from choosing its use. Different interventions have been described to decrease pain&#xD;
      perception during intrauterine device insertion with no agreement on an effective one.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>double blind randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind randomized controlled trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The difference in pain scores during intrauterine device insertion</measure>
    <time_frame>10 minutes</time_frame>
    <description>The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of IUD insertion</measure>
    <time_frame>10 minutes</time_frame>
    <description>duration of IUD insertion measured in minutes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>IUCD Complication</condition>
  <arm_group>
    <arm_group_label>INH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 vaginal tablet of isonicotinic acid hydrazide (900mg) ( inserted by the study nurse 4 hours before IUD insertion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Comparator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>one tablet of placebo inserted by the study nurse 4 hours before IUD insertion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INH</intervention_name>
    <description>3 vaginal tablet of isonicotinic acid hydrazide (900mg) inserted by the study nurse 4 hours before IUD insertion.</description>
    <arm_group_label>INH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Comparator</intervention_name>
    <description>3 tablet of placebo inserted by the study nurse 4 hours before IUD insertion.</description>
    <arm_group_label>Placebo Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-pregnant women&#xD;
&#xD;
          -  Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to&#xD;
             insertion&#xD;
&#xD;
          -  Women who delivered only by cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with any uterine abnormalities such as congenital anomalies, endometrial&#xD;
             lesions, adenomyosis, or fibroids.&#xD;
&#xD;
          -  Those with a Category 3 or 4 conditions for intrauterine device insertion according to&#xD;
             the WHO Medical Eligibility Criteria for contraceptive use&#xD;
&#xD;
          -  Allergy to isonicotinic acid hydrazide&#xD;
&#xD;
          -  known psychiatric disorders ( anxiety and depression) and chronic use of medications&#xD;
             that could interfere with pain perception (antidepressants and anticonvulsants)&#xD;
&#xD;
          -  Women refuse to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Non-pregnant women who delivered only by cesarean section</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>nahla w Shady, md</last_name>
    <role>Study Chair</role>
    <affiliation>Aswan universirty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aswan University Hospital</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>May 12, 2022</last_update_submitted>
  <last_update_submitted_qc>May 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aswan University Hospital</investigator_affiliation>
    <investigator_full_name>hany farouk</investigator_full_name>
    <investigator_title>A Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04500028
org study id: aswu/355/3/19
nct id: NCT04500028
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the
      levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions,
      insertion-related complications, and pain in Women With no Previous Vaginal Delivery.
Long-acting reversible contraception methods are highly effective methods for reduction of
      the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that
      provides reliable, effective and long term contraception for many women. However, the
      insertion procedure can be associated with a troublesome degree of pain that prevent some
      women from choosing its use. Different interventions have been described to decrease pain
      perception during intrauterine device insertion with no agreement on an effective one.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double blind randomized controlled trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blind randomized controlled trial
measure: The difference in pain scores during intrauterine device insertion
time frame: 10 minutes
description: The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10
measure: duration of IUD insertion
time frame: 10 minutes
description: duration of IUD insertion measured in minutes
arm group label: INH
arm group type: Experimental
description: 3 vaginal tablet of isonicotinic acid hydrazide (900mg) ( inserted by the study nurse 4 hours before IUD insertion.
arm group label: Placebo Comparator
arm group type: Placebo Comparator
description: one tablet of placebo inserted by the study nurse 4 hours before IUD insertion.
intervention type: Drug
intervention name: INH
description: 3 vaginal tablet of isonicotinic acid hydrazide (900mg) inserted by the study nurse 4 hours before IUD insertion.
arm group label: INH
intervention type: Drug
intervention name: Placebo Comparator
description: 3 tablet of placebo inserted by the study nurse 4 hours before IUD insertion.
arm group label: Placebo Comparator
criteria: 
gender: Female
gender based: Yes
gender description: Non-pregnant women who delivered only by cesarean section
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: nahla w Shady, md
role: Study Chair
affiliation: Aswan universirty
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: A Professor
sharing ipd: No