<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/NCT04500496</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/351/4/19</org_study_id>
    <nct_id>NCT04500496</nct_id>
  </id_info>
  <brief_title>Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy</brief_title>
  <official_title>Vaginal Dinoprostone Versus Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: 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 compare the effectiveness of vaginal dinoprostone and vaginal Isonicotinic acid hydrazide&#xD;
      in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce&#xD;
      hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the&#xD;
      hysteroscopist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as&#xD;
      polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during&#xD;
      the removal of an intrauterine device or foreign body. Cervical ripening is made possible by&#xD;
      the use of medication through different routes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">January 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <phase>N/A</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>open label randomized controlled study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>open label randomized controlled study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of pain</measure>
    <time_frame>10 minutes</time_frame>
    <description>Pain intensity will be assessed by visual analogue scale during the procedure. Visual analogue scale ranging from 0 to 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>15 minutes</time_frame>
    <description>From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity will be assessed by visual analogue scale</measure>
    <time_frame>30 minutes after the procedure</time_frame>
    <description>Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Postmenopausal Bleeding</condition>
  <arm_group>
    <arm_group_label>INH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 tablet of INH 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dinoprostone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia &amp; Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INH</intervention_name>
    <description>3 tablet of INH inserted by the patient 12 hours before the scheduled office hysteroscopy</description>
    <arm_group_label>INH</arm_group_label>
    <other_name>Isonicotinic acid hydrazide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dinoprostone</intervention_name>
    <description>1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia &amp; Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.</description>
    <arm_group_label>dinoprostone</arm_group_label>
    <other_name>prostin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding&#xD;
             or abnormal ultrasound ﬁndings)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nulliparous patients&#xD;
&#xD;
          -  patients with cervical pathology&#xD;
&#xD;
          -  retroverted uterus (detected by transvaginal ultrasound)&#xD;
&#xD;
          -  previous cervical surgery&#xD;
&#xD;
          -  patients with severe vaginal bleeding&#xD;
&#xD;
          -  allergy or contraindications to dinoprostone or INH therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Menopausal patients with an indication for ofﬁce hysteroscopy</gender_description>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>60 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>
  <overall_contact>
    <last_name>hany f Sallam, md</last_name>
    <phone>+20102435461</phone>
    <phone_ext>002</phone_ext>
    <email>hany.farouk@aswu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>nahla w Shady, md</last_name>
    <phone>+201022336052</phone>
    <phone_ext>002</phone_ext>
    <email>hanygyne@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aswan University Hospital</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hany F Sallam, MD</last_name>
      <phone>0122336052</phone>
      <phone_ext>002</phone_ext>
      <email>hany.farouk@aswu.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Nahla W Shady, MD</last_name>
      <phone>01092440504</phone>
      <phone_ext>002</phone_ext>
      <email>nahla.elsayed@aswu.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Isoniazid</mesh_term>
    <mesh_term>Dinoprostone</mesh_term>
  </intervention_browse>
  <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/NCT04500496
org study id: aswu/351/4/19
nct id: NCT04500496
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the effectiveness of vaginal dinoprostone and vaginal Isonicotinic acid hydrazide
      in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce
      hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the
      hysteroscopist.
hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as
      polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during
      the removal of an intrauterine device or foreign body. Cervical ripening is made possible by
      the use of medication through different routes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: open label randomized controlled study
primary purpose: Prevention
masking: None (Open Label)
masking description: open label randomized controlled study
measure: Intensity of pain
time frame: 10 minutes
description: Pain intensity will be assessed by visual analogue scale during the procedure. Visual analogue scale ranging from 0 to 10
measure: Operative time
time frame: 15 minutes
description: From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
measure: Pain intensity will be assessed by visual analogue scale
time frame: 30 minutes after the procedure
description: Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10
arm group label: INH
arm group type: Experimental
description: 3 tablet of INH 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.
arm group label: dinoprostone
arm group type: Active Comparator
description: 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
intervention type: Drug
intervention name: INH
description: 3 tablet of INH inserted by the patient 12 hours before the scheduled office hysteroscopy
arm group label: INH
other name: Isonicotinic acid hydrazide
intervention type: Drug
intervention name: dinoprostone
description: 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
arm group label: dinoprostone
other name: prostin
criteria: 
gender: Female
gender based: Yes
gender description: Menopausal patients with an indication for ofﬁce hysteroscopy
minimum age: 45 Years
maximum age: 60 Years
healthy volunteers: No
last name: nahla w Shady, md
role: Study Chair
affiliation: Aswan universirty
last name: hany f Sallam, md
phone: +20102435461
phone ext: 002
email: hany.farouk@aswu.edu.eg
last name: nahla w Shady, md
phone: +201022336052
phone ext: 002
email: hanygyne@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: A Professor
mesh term: Isoniazid
mesh term: Dinoprostone
sharing ipd: No