<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/NCT02985229</url>
  </required_header>
  <id_info>
    <org_study_id>1028</org_study_id>
    <nct_id>NCT02985229</nct_id>
  </id_info>
  <brief_title>Acceptability and Feasibility of Medical Abortion in Singapore</brief_title>
  <official_title>Acceptability and Feasibility of Medical Abortion in Singapore: A Study of 800 μg Buccal Misoprostol Following 200 mg Mifepristone for Abortion Through 70 Days Gestation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gynuity Health Projects</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gynuity Health Projects</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home&#xD;
      administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70&#xD;
      days LMP will be feasible and acceptable in Singapore.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of successful abortion</measure>
    <time_frame>7-10 days after mifepristone administration</time_frame>
    <description>Proportion of abortions that are complete without surgical intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the medical abortion method</measure>
    <time_frame>7-10 days after mifepristone administration</time_frame>
    <description>Proportion of women who are satisfied with the medical abortion method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preferred location of mifepristone administration</measure>
    <time_frame>The day of enrollment</time_frame>
    <description>Proportion of women who select home use of mifepristone</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Medical Abortion</condition>
  <arm_group>
    <arm_group_label>All participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in the study will be given the option of home administration of 200 mg oral mifepristone and 800 μg buccal misoprostol for medical abortion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mifepristone</intervention_name>
    <description>The option of home or clinic administration of 200 mg oral mifepristone</description>
    <arm_group_label>All participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>800 μg buccal misoprostol through 70 days LMP following administration of mifepristone</description>
    <arm_group_label>All participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have an intrauterine pregnancy consistent wit gestational age ≤ 70 days&#xD;
&#xD;
          -  Be 21 years of age or over&#xD;
&#xD;
          -  Be willing and able to sign consent forms&#xD;
&#xD;
          -  Be eligible for abortion according to current hospital guidelines&#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, email and/or telephone number for purposes of&#xD;
             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 inherited porphyrias&#xD;
&#xD;
          -  IUD in place (must be removed after mifepristone is administered).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beverly Winikoff, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynuity Health Projects</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KK Women's and Children's Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 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>
  <!-- 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/NCT02985229
org study id: 1028
nct id: NCT02985229
lead sponsor: 
has dmc: No
To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home
      administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70
      days LMP will be feasible and acceptable in Singapore.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of successful abortion
time frame: 7-10 days after mifepristone administration
description: Proportion of abortions that are complete without surgical intervention
measure: Satisfaction with the medical abortion method
time frame: 7-10 days after mifepristone administration
description: Proportion of women who are satisfied with the medical abortion method
measure: Preferred location of mifepristone administration
time frame: The day of enrollment
description: Proportion of women who select home use of mifepristone
arm group label: All participants
arm group type: Experimental
description: All participants in the study will be given the option of home administration of 200 mg oral mifepristone and 800 μg buccal misoprostol for medical abortion.
intervention type: Drug
intervention name: Mifepristone
description: The option of home or clinic administration of 200 mg oral mifepristone
arm group label: All participants
intervention type: Drug
intervention name: Misoprostol
description: 800 μg buccal misoprostol through 70 days LMP following administration of mifepristone
arm group label: All participants
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Beverly Winikoff, MD, MPH
role: Principal Investigator
affiliation: Gynuity Health Projects
facility: 
facility: 
country: Singapore
country: United States
responsible party type: Sponsor
mesh term: Misoprostol
mesh term: Mifepristone