<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/NCT03774745</url>
  </required_header>
  <id_info>
    <org_study_id>1353650</org_study_id>
    <nct_id>NCT03774745</nct_id>
  </id_info>
  <brief_title>Blocking Mifepristone Action With Progesterone</brief_title>
  <official_title>A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society of Family Planning</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Double-blind randomized trial to evaluate the potential impact of progesterone treatment on&#xD;
      early pregnancies exposed to mifepristone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medical abortion commonly refers to early pregnancy termination (usually before 10 weeks'&#xD;
      gestation) performed without primary surgical intervention and resulting from the use of&#xD;
      abortion-inducing medications. The use of medications to cause abortion has been around for&#xD;
      almost 70 years but the modern era of medical abortion treatment evolved with the development&#xD;
      of mifepristone, a progesterone-receptor blocker with an affinity for the receptor greater&#xD;
      than progesterone itself.&#xD;
&#xD;
      Medical abortion with mifepristone and misoprostol is highly effective; however, the risk of&#xD;
      continuing pregnancy is still present, especially as gestation advances. While most women opt&#xD;
      for further treatment in these scenarios, such as surgical aspiration, there are some who&#xD;
      decide to continue the pregnancy. Thus, even following treatment, some women do change their&#xD;
      mind.&#xD;
&#xD;
      No well-done study has evaluated whether such treatment works. Poorly controlled case series&#xD;
      are not evidence and systematic reviews of continuing pregnancy rates after&#xD;
      mifepristone/prostaglandin analogue treatment failure do not reflect real life outcomes. This&#xD;
      study is also a first step to understanding if large studies evaluating mifepristone&#xD;
      antagonization with high-dose progesterone are indicated and if placebo-controlled randomized&#xD;
      trials can be successfully completed when evaluating this question.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Safety&#xD;
  </why_stopped>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Actual">August 15, 2019</completion_date>
  <primary_completion_date type="Actual">July 29, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Randomized, double blind, placebo controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>placebo pills in opaque bottle</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Continuing Pregnancy Based on Ultrasound Examination</measure>
    <time_frame>at 14-16 days after mifepristone administration</time_frame>
    <description>Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Expulsion During Follow-up Evaluation</measure>
    <time_frame>up to 16 days after mifepristone administration</time_frame>
    <description>Pregnancy expulsion following mifepristone treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events During Follow-up Evaluation</measure>
    <time_frame>up to 16 days after mifepristone administration</time_frame>
    <description>Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Safety During Treatment and Follow-up</measure>
    <time_frame>up to 16 days after mifepristone administration</time_frame>
    <description>Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Change in Serum Progesterone and hCG During Follow-up</measure>
    <time_frame>up to 16 days after mifepristone administration</time_frame>
    <description>Change in serum progesterone and hCG during follow-up evaluation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Pregnancy, Unwanted</condition>
  <arm_group>
    <arm_group_label>Progesterone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).&#xD;
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo oral capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mifepristone 200 MG</intervention_name>
    <description>All subjects receive mifepristone tablet on treatment day 1.</description>
    <arm_group_label>Placebo oral capsule</arm_group_label>
    <arm_group_label>Progesterone</arm_group_label>
    <other_name>Mifeprex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>micronized Progesterone</intervention_name>
    <description>Subjects randomized to progesterone receive treatment starting day 2.</description>
    <arm_group_label>Progesterone</arm_group_label>
    <other_name>Prometrium</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Subjects randomized to placebo receive treatment starting day 2.</description>
    <arm_group_label>Placebo oral capsule</arm_group_label>
    <other_name>Placebo (for micronized progesterone)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant females 18 years and older at enrollment.&#xD;
&#xD;
          2. Seeking surgical abortion at 44-63 days' gestation on Study day 1.&#xD;
&#xD;
          3. Have received counseling and signed informed consent per UCD standard procedures for&#xD;
             surgical abortion.&#xD;
&#xD;
          4. Presence of embryonic gestational cardiac activity on transvaginal ultrasonography.&#xD;
&#xD;
          5. English-speaking&#xD;
&#xD;
          6. Willing to sign informed consent and follow study protocol.&#xD;
&#xD;
          7. Willing to experience potential expulsion of the pregnancy with mifepristone&#xD;
             treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical contraindications to medical abortion.&#xD;
&#xD;
               1. Poorly controlled hypertension (systolic BP &gt;160 or diastolic BP &gt;95)&#xD;
&#xD;
               2. Significant anemia - known recent hemoglobin &lt;9.5 gm/dL&#xD;
&#xD;
               3. Clinically significant cardiovascular disease (angina, valvular disease,&#xD;
                  arrhythmia, or congestive heart failure)&#xD;
&#xD;
               4. Breastfeeding&#xD;
&#xD;
               5. Coagulopathy or therapeutic coagulation&#xD;
&#xD;
               6. Ultrasound evidence of molar or ectopic pregnancy&#xD;
&#xD;
               7. Chronic systemic corticosteroid use&#xD;
&#xD;
               8. Adrenal disease&#xD;
&#xD;
               9. Sickle cell anemia with frequent/recent crises&#xD;
&#xD;
              10. Glaucoma&#xD;
&#xD;
          2. IUD in place during conception, even if removed.&#xD;
&#xD;
          3. Peanut allergy.&#xD;
&#xD;
          4. Known intolerance of mifepristone or progesterone.&#xD;
&#xD;
          5. Any other condition, that in the opinion of the clinician, would contraindicate&#xD;
             mifepristone, progesterone or medical abortion.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Biologic females who are pregnant</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mitchell D Creinin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Planned Parenthood Mar Monte</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Planning Associates</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <results_first_submitted>December 30, 2019</results_first_submitted>
  <results_first_submitted_qc>January 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 22, 2020</results_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mifepristone</keyword>
  <keyword>progesterone</keyword>
  <keyword>abortion</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mifepristone</mesh_term>
    <mesh_term>Progesterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Sharing de-identified data will be considered upon individual request</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03774745/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Progesterone</title>
          <description>Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).&#xD;
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.</description>
        </group>
        <group group_id="P2">
          <title>Placebo Oral Capsule</title>
          <description>Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Follow-Up 1</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Follow-up 2</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intended to enroll 40 total - study stopped after 12 enrolled due to safety concerns</population>
      <group_list>
        <group group_id="B1">
          <title>Progesterone</title>
          <description>Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).&#xD;
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.</description>
        </group>
        <group group_id="B2">
          <title>Placebo Oral Capsule</title>
          <description>Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.8" lower_limit="24.6" upper_limit="39.6"/>
                    <measurement group_id="B2" value="24.1" lower_limit="20.9" upper_limit="33.8"/>
                    <measurement group_id="B3" value="27.3" lower_limit="20.9" upper_limit="39.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational Age</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.5" lower_limit="47" upper_limit="56"/>
                    <measurement group_id="B2" value="55" lower_limit="48" upper_limit="61"/>
                    <measurement group_id="B3" value="52.5" lower_limit="47" upper_limit="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.8" lower_limit="19.0" upper_limit="36.4"/>
                    <measurement group_id="B2" value="24.6" lower_limit="22.7" upper_limit="52.3"/>
                    <measurement group_id="B3" value="24.6" lower_limit="19.0" upper_limit="52.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Obesity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gravidity</title>
          <units>number of pregnancies</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.5" lower_limit="1" upper_limit="10"/>
                    <measurement group_id="B2" value="3.5" lower_limit="1" upper_limit="12"/>
                    <measurement group_id="B3" value="4" lower_limit="1" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity</title>
          <units>number of deliveries</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.5" lower_limit="0" upper_limit="6"/>
                    <measurement group_id="B2" value="0.5" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B3" value="1" lower_limit="0" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Past mifepristone use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior progesterone use (n, %)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Continuing Pregnancy Based on Ultrasound Examination</title>
        <description>Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination</description>
        <time_frame>at 14-16 days after mifepristone administration</time_frame>
        <population>Intention to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone</title>
            <description>Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).&#xD;
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Continuing Pregnancy Based on Ultrasound Examination</title>
          <description>Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination</description>
          <population>Intention to treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expulsion During Follow-up Evaluation</title>
        <description>Pregnancy expulsion following mifepristone treatment</description>
        <time_frame>up to 16 days after mifepristone administration</time_frame>
        <population>intention to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone</title>
            <description>Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).&#xD;
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Expulsion During Follow-up Evaluation</title>
          <description>Pregnancy expulsion following mifepristone treatment</description>
          <population>intention to treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events During Follow-up Evaluation</title>
        <description>Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed</description>
        <time_frame>up to 16 days after mifepristone administration</time_frame>
        <population>increased to severe at any time during follow-up</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone</title>
            <description>Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).&#xD;
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events During Follow-up Evaluation</title>
          <description>Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed</description>
          <population>increased to severe at any time during follow-up</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mastalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tiredness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mood changes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reflux</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dizziness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spotting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cramping</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medical Safety During Treatment and Follow-up</title>
        <description>Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures</description>
        <time_frame>up to 16 days after mifepristone administration</time_frame>
        <population>intent to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone</title>
            <description>Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).&#xD;
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Medical Safety During Treatment and Follow-up</title>
          <description>Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures</description>
          <population>intent to treat</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemorrhage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emergency Room Visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transfusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emergent D&amp;C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Side effects - request D&amp;C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Change in Serum Progesterone and hCG During Follow-up</title>
        <description>Change in serum progesterone and hCG during follow-up evaluation</description>
        <time_frame>up to 16 days after mifepristone administration</time_frame>
        <population>intent to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Progesterone</title>
            <description>Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).&#xD;
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change in Serum Progesterone and hCG During Follow-up</title>
          <description>Change in serum progesterone and hCG during follow-up evaluation</description>
          <population>intent to treat</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Progesterone increase from baseline at FU 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progesterone decrease from baseline at FU 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hCG increase from baseline at FU 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hCG decrease from baseline at FU 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Two weeks</time_frame>
      <desc>Adverse event included hemorrhage, emergency room visit, transfusion, emergent D&amp;C</desc>
      <group_list>
        <group group_id="E1">
          <title>Progesterone</title>
          <description>Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).&#xD;
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
micronized Progesterone: Subjects randomized to progesterone receive treatment starting day 2.</description>
        </group>
        <group group_id="E2">
          <title>Placebo Oral Capsule</title>
          <description>Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.&#xD;
Mifepristone 200 MG: All subjects receive mifepristone tablet on treatment day 1.&#xD;
Placebo oral capsule: Subjects randomized to placebo receive treatment starting day 2.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Transfusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Emergency D&amp;C</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Emergency Room Visit</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Side effects requesting study discontinuation</sub_title>
                <description>Requested D&amp;C for abortion because could not tolerate medications/pregnancy</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination for safety reasons leading to small numbers of subjects analyzed for efficacy outcomes. Imbalance in participant characteristics due to early termination.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Mitchell Creinin</name_or_title>
      <organization>University of California, Davis</organization>
      <phone>916-734-6670</phone>
      <email>mdcreinin@ucdavis.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03774745
org study id: 1353650
nct id: NCT03774745
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Double-blind randomized trial to evaluate the potential impact of progesterone treatment on
      early pregnancies exposed to mifepristone.
Medical abortion commonly refers to early pregnancy termination (usually before 10 weeks'
      gestation) performed without primary surgical intervention and resulting from the use of
      abortion-inducing medications. The use of medications to cause abortion has been around for
      almost 70 years but the modern era of medical abortion treatment evolved with the development
      of mifepristone, a progesterone-receptor blocker with an affinity for the receptor greater
      than progesterone itself.

      Medical abortion with mifepristone and misoprostol is highly effective; however, the risk of
      continuing pregnancy is still present, especially as gestation advances. While most women opt
      for further treatment in these scenarios, such as surgical aspiration, there are some who
      decide to continue the pregnancy. Thus, even following treatment, some women do change their
      mind.

      No well-done study has evaluated whether such treatment works. Poorly controlled case series
      are not evidence and systematic reviews of continuing pregnancy rates after
      mifepristone/prostaglandin analogue treatment failure do not reflect real life outcomes. This
      study is also a first step to understanding if large studies evaluating mifepristone
      antagonization with high-dose progesterone are indicated and if placebo-controlled randomized
      trials can be successfully completed when evaluating this question.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double blind, placebo controlled trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: placebo pills in opaque bottle
measure: Continuing Pregnancy Based on Ultrasound Examination
time frame: at 14-16 days after mifepristone administration
description: Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination
measure: Expulsion During Follow-up Evaluation
time frame: up to 16 days after mifepristone administration
description: Pregnancy expulsion following mifepristone treatment
measure: Number of Participants With Adverse Events During Follow-up Evaluation
time frame: up to 16 days after mifepristone administration
description: Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed
measure: Medical Safety During Treatment and Follow-up
time frame: up to 16 days after mifepristone administration
description: Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures
measure: Number of Participants With Change in Serum Progesterone and hCG During Follow-up
time frame: up to 16 days after mifepristone administration
description: Change in serum progesterone and hCG during follow-up evaluation
arm group label: Progesterone
arm group type: Experimental
description: Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
arm group label: Placebo oral capsule
arm group type: Placebo Comparator
description: Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
intervention type: Drug
intervention name: Mifepristone 200 MG
description: All subjects receive mifepristone tablet on treatment day 1.
arm group label: Placebo oral capsule
arm group label: Progesterone
other name: Mifeprex
intervention type: Drug
intervention name: micronized Progesterone
description: Subjects randomized to progesterone receive treatment starting day 2.
arm group label: Progesterone
other name: Prometrium
intervention type: Drug
intervention name: Placebo oral capsule
description: Subjects randomized to placebo receive treatment starting day 2.
arm group label: Placebo oral capsule
other name: Placebo (for micronized progesterone)
criteria: 
gender: Female
gender based: Yes
gender description: Biologic females who are pregnant
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mitchell D Creinin, MD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mifepristone
mesh term: Progesterone
sharing ipd: No
ipd description: Sharing de-identified data will be considered upon individual request
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination for safety reasons leading to small numbers of subjects analyzed for efficacy outcomes. Imbalance in participant characteristics due to early termination.
point of contact: 