<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/NCT04500015</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/354/4/19</org_study_id>
    <nct_id>NCT04500015</nct_id>
  </id_info>
  <brief_title>Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion</brief_title>
  <official_title>Benefits of Self-administered Vaginal Isonicotinic Acid Hydrazide (INH) Administration 12 Hours Prior to Intrauterine Device Insertion in Adolescent and Young Women: a Randomized Controlled 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 administered before the&#xD;
      levonorgestrel-releasing intrauterine system insertion reduces IUD insertion pain and&#xD;
      difficulty in insertion in adolescents and young women.&#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">September 1, 2020</start_date>
  <completion_date type="Actual">August 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 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 study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind randomized controlled study</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>
  <secondary_outcome>
    <measure>Provider ease of insertion</measure>
    <time_frame>10 minutes</time_frame>
    <description>Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</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 self-inserted by the patient 12 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>3 tablet of placebo self-administered by the patient 12 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 self-inserted by the patient 12 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 self-inserted by the patient 12 hours before IUD insertion.</description>
    <arm_group_label>Placebo Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  nulliparous adolescent and young women requesting levonorgestrel-releasing&#xD;
             intrauterine device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy and&#xD;
&#xD;
          -  contraindication or allergy to or contraindication to IUD insertion,&#xD;
&#xD;
          -  chronic pelvic pain,&#xD;
&#xD;
          -  pelvic inflammatory disease,&#xD;
&#xD;
          -  analgesic intake 24 hours prior to IUD insertion.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>adolescents and young women.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 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>September 2021</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>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</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/NCT04500015
org study id: aswu/354/4/19
nct id: NCT04500015
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate whether vaginal isonicotinic acid hydrazide administered before the
      levonorgestrel-releasing intrauterine system insertion reduces IUD insertion pain and
      difficulty in insertion in adolescents and young women.
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 study
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blind randomized controlled study
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
measure: Provider ease of insertion
time frame: 10 minutes
description: Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.
arm group label: INH
arm group type: Experimental
description: 3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.
arm group label: Placebo Comparator
arm group type: Placebo Comparator
description: 3 tablet of placebo self-administered by the patient 12 hours before IUD insertion
intervention type: Drug
intervention name: INH
description: 3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.
arm group label: INH
intervention type: Drug
intervention name: Placebo Comparator
description: 3 tablet of placebo self-inserted by the patient 12 hours before IUD insertion.
arm group label: Placebo Comparator
criteria: 
gender: Female
gender based: Yes
gender description: adolescents and young women.
minimum age: 18 Years
maximum age: 25 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