<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/NCT02967055</url>
  </required_header>
  <id_info>
    <org_study_id>16-0614</org_study_id>
    <nct_id>NCT02967055</nct_id>
  </id_info>
  <brief_title>The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant</brief_title>
  <official_title>The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</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 Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of&#xD;
      isotretinoin on the etonogestrel (ENG) contraceptive implant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Investigators will enroll only women with an etonogestrel contraceptive implant in place&#xD;
      who are initiating isotretinoin therapy through their dermatologist. The Investigators will&#xD;
      monitor the subjects serum etonogestrel concentration during isotretinoin therapy but no&#xD;
      medications will be provided through this study. No medical devices will be inserted as part&#xD;
      of this study either.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Etonogestrel (ENG) Level</measure>
    <time_frame>Baseline (enrollment)</time_frame>
    <description>ENG levels will be measured prior to initiation of isotretinoin therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Etonogestrel (ENG) Level</measure>
    <time_frame>4 weeks</time_frame>
    <description>ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Etonogestrel (ENG) Level</measure>
    <time_frame>9 weeks</time_frame>
    <description>ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.</description>
  </primary_outcome>
  <enrollment type="Actual">9</enrollment>
  <condition>Contraception</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Reproductive-aged women (18-45) who are under the care of a dermatologist for treatment of&#xD;
        acne and planning to initiate therapy with isotretinoin. The women must have chosen an ENG&#xD;
        contraceptive implant for their primary mechanism of birth control, placed at least four&#xD;
        weeks prior to study enrollment, but in place no longer than three years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a secondary form of non-hormonal contraception or abstain during isotretinoin&#xD;
             therapy and four weeks afterwards&#xD;
&#xD;
          -  Have at least two negative pregnancy tests at least 19 days apart prior to initiating&#xD;
             isotretinoin therapy&#xD;
&#xD;
          -  Have normal baseline laboratory evaluation including liver function tests, basic&#xD;
             metabolic panel, and complete blood count&#xD;
&#xD;
          -  Willing to abstain from taking any Vitamin A supplement during the study period&#xD;
&#xD;
          -  Have a Body Mass Index (BMI) &gt;= 18.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently breastfeeding&#xD;
&#xD;
          -  Known contraindications to isotretinoin&#xD;
&#xD;
          -  Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Lazorwitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <results_first_submitted>July 7, 2020</results_first_submitted>
  <results_first_submitted_qc>July 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 11, 2020</results_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>September 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT02967055/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Enrolled Participants</title>
          <description>Participants meeting all inclusion/exclusion criteria and enrolled into the study</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="54">Assessed for eligibility</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>In-person Screening</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Enrolled</title>
              <participants_list>
                <participants group_id="P1" count="9">Enrolled</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 4 Week Follow-up Visit</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Excluded</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen fail</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Stopped due to side effects</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Stopped due to drug cost</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Enrolled Participants</title>
          <description>Participants meeting all inclusion/exclusion criteria and enrolled into the study</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </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="21" lower_limit="18" upper_limit="26"/>
                  </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="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body-mass index</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="27.4" lower_limit="21.1" upper_limit="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Serum Etonogestrel (ENG) Level</title>
        <description>ENG levels will be measured prior to initiation of isotretinoin therapy.</description>
        <time_frame>Baseline (enrollment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled Participants</title>
            <description>Participants meeting all inclusion/exclusion criteria and enrolled into the study</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Etonogestrel (ENG) Level</title>
          <description>ENG levels will be measured prior to initiation of isotretinoin therapy.</description>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="243.3" lower_limit="166.14" upper_limit="294.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serum Etonogestrel (ENG) Level</title>
        <description>ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled Participants</title>
            <description>Participants meeting all inclusion/exclusion criteria and enrolled into the study</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Etonogestrel (ENG) Level</title>
          <description>ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.</description>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="234.0" lower_limit="185.0" upper_limit="256.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serum Etonogestrel (ENG) Level</title>
        <description>ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.</description>
        <time_frame>9 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled Participants</title>
            <description>Participants meeting all inclusion/exclusion criteria and enrolled into the study</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Etonogestrel (ENG) Level</title>
          <description>ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.</description>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.4" lower_limit="138.6" upper_limit="235.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>20 weeks from onset of isotretinoin therapy</time_frame>
      <desc>Collected primarily any pregnancies</desc>
      <group_list>
        <group group_id="E1">
          <title>Enrolled Participants</title>
          <description>Participants meeting all inclusion/exclusion criteria and enrolled into the study</description>
        </group>
      </group_list>
      <serious_events>
        <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="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Aaron Lazorwitz</name_or_title>
      <organization>University of Colorado Anschutz Medical Campus</organization>
      <phone>3037242019</phone>
      <email>aaron.lazorwitz@cuanschutz.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/NCT02967055
org study id: 16-0614
nct id: NCT02967055
lead sponsor: 
collaborator: 
has dmc: No
This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of
      isotretinoin on the etonogestrel (ENG) contraceptive implant.
The Investigators will enroll only women with an etonogestrel contraceptive implant in place
      who are initiating isotretinoin therapy through their dermatologist. The Investigators will
      monitor the subjects serum etonogestrel concentration during isotretinoin therapy but no
      medications will be provided through this study. No medical devices will be inserted as part
      of this study either.
observational model: Cohort
time perspective: Prospective
measure: Serum Etonogestrel (ENG) Level
time frame: Baseline (enrollment)
description: ENG levels will be measured prior to initiation of isotretinoin therapy.
measure: Serum Etonogestrel (ENG) Level
time frame: 4 weeks
description: ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.
measure: Serum Etonogestrel (ENG) Level
time frame: 9 weeks
description: ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aaron Lazorwitz, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 