<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/NCT02981030</url>
  </required_header>
  <id_info>
    <org_study_id>1037</org_study_id>
    <nct_id>NCT02981030</nct_id>
  </id_info>
  <brief_title>Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine</brief_title>
  <official_title>Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine: A Demonstration Study of 800 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gynuity Health Projects</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Charitable Foundation Women Health &amp; Family Planning</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gynuity Health Projects</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will examine how a simplified outpatient medical abortion procedure using&#xD;
      mifepristone and misoprostol, with the option to take mifepristone at a place of woman's&#xD;
      choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral&#xD;
      administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with&#xD;
      gestations through 70 days, as well as the acceptability of this method.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 23, 2016</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <phase>Phase 4</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of successful abortion</measure>
    <time_frame>2 weeks after mifepristone administration</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Abortion, Therapeutic</condition>
  <arm_group>
    <arm_group_label>Simplified medical abortion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mifepristone</intervention_name>
    <description>Women seeking medical abortion will be offered the option to take mifepristone at home</description>
    <arm_group_label>Simplified medical abortion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Women seeking medical abortion will be offered the option to take misoprostol at home. Misoprostol will be administered buccally.</description>
    <arm_group_label>Simplified medical abortion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have an intrauterine pregnancy consistent with gestational age less than 71 days;&#xD;
&#xD;
          -  Be able to understand and willing to sign a consent form;&#xD;
&#xD;
          -  Be eligible for medical abortion according to the clinician's assessment;&#xD;
&#xD;
          -  Be able to return to the clinic and able to contact study staff or emergency medical&#xD;
             services, if needed;&#xD;
&#xD;
          -  Be willing to provide an address and/or telephone number for purposes of follow-up;&#xD;
&#xD;
          -  Agree to comply with the study procedures and visit schedule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;&#xD;
&#xD;
          -  Chronic renal failure;&#xD;
&#xD;
          -  Concurrent long-term corticosteroid therapy;&#xD;
&#xD;
          -  History of allergy to mifepristone, or misoprostol or another prostaglandin;&#xD;
&#xD;
          -  History of hemorrhagic disorders or concurrent anticoagulant therapy;&#xD;
&#xD;
          -  History of inherited porphyrias;&#xD;
&#xD;
          -  Intrauterine device in place (must be removed before mifepristone is administered).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingrida Platais, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynuity Health Projects</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tamar Tsereteli, MD, MSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynuity Health Projects</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Beverly Winikoff, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynuity Health Projects</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Galyna Maystruk, MD</last_name>
    <role>Study Director</role>
    <affiliation>Charitable Foundation Women Health &amp; Family Planning</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lviv Municipal Women's Consultation No. 2</name>
      <address>
        <city>L'viv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinnitsa Regional Clinical Hospital</name>
      <address>
        <city>Vinnitsa</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ukraine</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>June 14, 2018</last_update_submitted>
  <last_update_submitted_qc>June 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
    <mesh_term>Mifepristone</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/NCT02981030
org study id: 1037
nct id: NCT02981030
lead sponsor: 
collaborator: 
has dmc: No
The study will examine how a simplified outpatient medical abortion procedure using
      mifepristone and misoprostol, with the option to take mifepristone at a place of woman's
      choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral
      administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with
      gestations through 70 days, as well as the acceptability of this method.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Rate of successful abortion
time frame: 2 weeks after mifepristone administration
arm group label: Simplified medical abortion
arm group type: Experimental
description: Women seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home.
intervention type: Drug
intervention name: Mifepristone
description: Women seeking medical abortion will be offered the option to take mifepristone at home
arm group label: Simplified medical abortion
intervention type: Drug
intervention name: Misoprostol
description: Women seeking medical abortion will be offered the option to take misoprostol at home. Misoprostol will be administered buccally.
arm group label: Simplified medical abortion
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ingrida Platais, MS
role: Principal Investigator
affiliation: Gynuity Health Projects
last name: Tamar Tsereteli, MD, MSc, PhD
role: Principal Investigator
affiliation: Gynuity Health Projects
last name: Beverly Winikoff, MD, MPH
role: Principal Investigator
affiliation: Gynuity Health Projects
last name: Galyna Maystruk, MD
role: Study Director
affiliation: Charitable Foundation Women Health & Family Planning
facility: 
facility: 
country: Ukraine
responsible party type: Sponsor
mesh term: Misoprostol
mesh term: Mifepristone
sharing ipd: No