<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/NCT01718314</url>
  </required_header>
  <id_info>
    <org_study_id>HEK 11/33-21</org_study_id>
    <nct_id>NCT01718314</nct_id>
  </id_info>
  <brief_title>Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy</brief_title>
  <official_title>Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Sami Ulus Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. Sami Ulus Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables&#xD;
      the doctor to do minor operative procedures. Although it causes little discomfort, sometimes&#xD;
      it may be disturbing for the patient. This pain is usually perceived during the passage of&#xD;
      the instrument through the cervix (neck of the womb). The investigators would like to&#xD;
      minimize this pain by two drugs: Misoprotol and lidocaine&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Outpatient or office hysteroscopy has become the 'gold standard' for the investigation of the&#xD;
      intrauterine abnormalities. This minimal invasive modality provides brilliant and clear&#xD;
      visualization of the entire uterine cavity and besides this, by the operative channel, minor&#xD;
      procedures may easily be performed in the office setting which is priceless for the&#xD;
      gynecologist. However, pain related to the procedure may make the procedure uncomfortable for&#xD;
      the patient and the physician. Together with the operative time, hysteroscope diameter is&#xD;
      considered as the main factor influencing pain. The pain perceived during hysteroscopy may be&#xD;
      reduced by using a smaller diameter hysteroscope or by using anesthesia, which decreases pain&#xD;
      perception.&#xD;
&#xD;
      In this prospective, randomized, double blind, placebo controlled study, we aim to compare&#xD;
      the effectiveness of sublingual misoprostol versus lidocaine pump spray for pain relief&#xD;
      during office hysteroscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2008</start_date>
  <completion_date type="Actual">March 2010</completion_date>
  <primary_completion_date type="Actual">December 2009</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient VAS score immediately after the procedure</measure>
    <time_frame>Immediately after the procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient VAS score 10 minutes after the procedure</measure>
    <time_frame>10 minutes after the procedure</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Need for cervical dilation</measure>
    <time_frame>During the procedure</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Pain During Hysteroscopy</condition>
  <arm_group>
    <arm_group_label>Sublingual Misoprostol &amp; Lidocaine placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine Pump Spray &amp; Misoprostol placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sublingual Misoprostol</intervention_name>
    <arm_group_label>Sublingual Misoprostol &amp; Lidocaine placebo</arm_group_label>
    <other_name>Cytotec</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine pump spray</intervention_name>
    <arm_group_label>Lidocaine Pump Spray &amp; Misoprostol placebo</arm_group_label>
    <other_name>Xylocaine %10 pump spray</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for Misoprostol)</intervention_name>
    <description>Lactose filler, the pharmacy-produced pills identical to original misoprostol pill</description>
    <arm_group_label>Lidocaine Pump Spray &amp; Misoprostol placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for Lidocaine)</intervention_name>
    <description>The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray</description>
    <arm_group_label>Sublingual Misoprostol &amp; Lidocaine placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premenopausal women in the proliferative phase of the menstrual cycle with no&#xD;
             contraindication for hysteroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vaginal bleeding at the time of the procedure&#xD;
&#xD;
          -  known sensitivity to lidocaine (amide group local anesthetics) or prostaglandins&#xD;
&#xD;
          -  epilepsy&#xD;
&#xD;
          -  significantly impaired respiratory or cardiac conduction functions&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  glaucoma&#xD;
&#xD;
          -  renal failure&#xD;
&#xD;
          -  acute liver disease&#xD;
&#xD;
          -  uncontrolled diabetes mellitus&#xD;
&#xD;
          -  pregnancy or suspicion of pregnancy&#xD;
&#xD;
          -  pelvic inflammatory disease&#xD;
&#xD;
          -  cervical operation history&#xD;
&#xD;
          -  vaginismus.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>51 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tuncay Kucukozkan, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Sami Ulus Maternity and Childrens Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr Sami Ulus Maternity and Children Training and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06090</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.</citation>
    <PMID>17516956</PMID>
  </results_reference>
  <results_reference>
    <citation>De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.</citation>
    <PMID>10648742</PMID>
  </results_reference>
  <results_reference>
    <citation>Mulayim B, Celik NY, Onalan G, Bagis T, Zeyneloglu HB. Sublingual misoprostol for cervical ripening before diagnostic hysteroscopy in premenopausal women: a randomized, double blind, placebo-controlled trial. Fertil Steril. 2010 May 1;93(7):2400-4. doi: 10.1016/j.fertnstert.2009.01.073. Epub 2009 Feb 24.</citation>
    <PMID>19243750</PMID>
  </results_reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 30, 2012</last_update_submitted>
  <last_update_submitted_qc>October 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr. Sami Ulus Children's Hospital</investigator_affiliation>
    <investigator_full_name>Sertac ESIN</investigator_full_name>
    <investigator_title>Obstetrician and Gynecologist</investigator_title>
  </responsible_party>
  <keyword>Hysteroscopy</keyword>
  <keyword>Misoprostol</keyword>
  <keyword>Lidocaine</keyword>
  <keyword>Visual analogue score</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Misoprostol</mesh_term>
  </intervention_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/NCT01718314
org study id: HEK 11/33-21
nct id: NCT01718314
lead sponsor: 
has dmc: No
Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables
      the doctor to do minor operative procedures. Although it causes little discomfort, sometimes
      it may be disturbing for the patient. This pain is usually perceived during the passage of
      the instrument through the cervix (neck of the womb). The investigators would like to
      minimize this pain by two drugs: Misoprotol and lidocaine
Outpatient or office hysteroscopy has become the 'gold standard' for the investigation of the
      intrauterine abnormalities. This minimal invasive modality provides brilliant and clear
      visualization of the entire uterine cavity and besides this, by the operative channel, minor
      procedures may easily be performed in the office setting which is priceless for the
      gynecologist. However, pain related to the procedure may make the procedure uncomfortable for
      the patient and the physician. Together with the operative time, hysteroscope diameter is
      considered as the main factor influencing pain. The pain perceived during hysteroscopy may be
      reduced by using a smaller diameter hysteroscope or by using anesthesia, which decreases pain
      perception.

      In this prospective, randomized, double blind, placebo controlled study, we aim to compare
      the effectiveness of sublingual misoprostol versus lidocaine pump spray for pain relief
      during office hysteroscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Patient VAS score immediately after the procedure
time frame: Immediately after the procedure
measure: Patient VAS score 10 minutes after the procedure
time frame: 10 minutes after the procedure
measure: Need for cervical dilation
time frame: During the procedure
arm group label: Sublingual Misoprostol & Lidocaine placebo
arm group type: Experimental
description: Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo
arm group label: Lidocaine Pump Spray & Misoprostol placebo
arm group type: Experimental
description: Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo
intervention type: Drug
intervention name: Sublingual Misoprostol
arm group label: Sublingual Misoprostol & Lidocaine placebo
other name: Cytotec
intervention type: Drug
intervention name: Lidocaine pump spray
arm group label: Lidocaine Pump Spray & Misoprostol placebo
other name: Xylocaine %10 pump spray
intervention type: Drug
intervention name: Placebo (for Misoprostol)
description: Lactose filler, the pharmacy-produced pills identical to original misoprostol pill
arm group label: Lidocaine Pump Spray & Misoprostol placebo
intervention type: Drug
intervention name: Placebo (for Lidocaine)
description: The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray
arm group label: Sublingual Misoprostol & Lidocaine placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 51 Years
healthy volunteers: No
last name: Tuncay Kucukozkan, Professor
role: Study Chair
affiliation: Sami Ulus Maternity and Childrens Hospital
facility: 
country: Turkey
citation: van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.
PMID: 17516956
citation: De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.
PMID: 10648742
citation: Mulayim B, Celik NY, Onalan G, Bagis T, Zeyneloglu HB. Sublingual misoprostol for cervical ripening before diagnostic hysteroscopy in premenopausal women: a randomized, double blind, placebo-controlled trial. Fertil Steril. 2010 May 1;93(7):2400-4. doi: 10.1016/j.fertnstert.2009.01.073. Epub 2009 Feb 24.
PMID: 19243750
responsible party type: Principal Investigator
investigator affiliation: Dr. Sami Ulus Children's Hospital
investigator full name: Sertac ESIN
investigator title: Obstetrician and Gynecologist
mesh term: Lidocaine
mesh term: Misoprostol