<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/NCT04463693</url>
  </required_header>
  <id_info>
    <org_study_id>20-0574</org_study_id>
    <nct_id>NCT04463693</nct_id>
  </id_info>
  <brief_title>Shoulder Contraceptive Implant Study</brief_title>
  <official_title>Pilot Study of Etonogestrel Contraceptive Implant Insertion at an Alternative Subdermal Scapular Site</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study will be the first to establish pharmacokinetic curves for the etonogestrel&#xD;
      contraceptive implant with scapular subdermal insertion. By obtaining this pharmacokinetic&#xD;
      data, the investigators can compare this data to already published pharmacokinetic data with&#xD;
      conventional implant insertion. This comparison can provide some reassurance that the&#xD;
      absorption and distribution of etonogestrel from the contraceptive implant with scapular&#xD;
      insertion is similar to that found with conventional insertion. With similar pharmacokinetic&#xD;
      properties, the investigators would expect scapular insertion of the implant to maintain&#xD;
      similar contraceptive efficacy for the populations of women that may benefit from this&#xD;
      alternative insertion site. Preliminary safety data will also enrich the understanding of any&#xD;
      potential insertion site side effects with subdermal scapular implant insertion, as the&#xD;
      investigators currently only have a single case report with side effect outcomes. The&#xD;
      investigators can then use this pilot data to support future larger investigations on&#xD;
      subdermal scapular implant insertion given its complete avoidance of the neurovascular&#xD;
      complications associated with arm insertion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The etonogestrel contraceptive implant (Nexplanon®) remains the most effective hormonal&#xD;
      contraceptive method available in the U.S. The contraceptive implant is routinely inserted&#xD;
      just beneath the skin on the inner-side of the non-dominant arm, but insertion at this site&#xD;
      has resulted in rare, yet potentially morbid complications. These complications are due to&#xD;
      the close proximity of major neurovascular structures (e.g. basilic vein, ulnar nerve) in the&#xD;
      sulcus between the biceps and triceps muscles. Insertion of the implant deep in the arm has&#xD;
      resulted in severe complications including migration of the implant into the pulmonary&#xD;
      vasculature and neurological injury at the time of implant removal. Though these&#xD;
      complications are rare, their report directly led to changes in the manufacturer's mandatory&#xD;
      insertion training to move the implant insertion site inferiorly, though it is unlikely that&#xD;
      this change will completely remove the risk of these rare insertion complications.&#xD;
&#xD;
      In addition to the rare complications of deep implant insertion in the arm, patients with&#xD;
      specific medical conditions are also not ideal candidates for this standard insertion site.&#xD;
      Patients with psychotic illnesses or development delays often require reliable contraception,&#xD;
      but the arm insertion site for the implant is easily accessible and injuries can result from&#xD;
      self-removal attempts among these patients. Furthermore, patients with muscular dystrophy&#xD;
      disorders may not have adequate tissue in this region of the arm to buffer the implant from&#xD;
      the underlying neurovascular structures. In order to address the needs of these patient&#xD;
      populations, insertion of the contraceptive implant at an alternative subdermal scapular site&#xD;
      has been reported in the literature. This insertion just beneath the skin overlying the&#xD;
      inferior edge of the scapula represents an ideal alternative location for the contraceptive&#xD;
      implant due to its location far from danger zones of neurovascular structures,&#xD;
      inaccessibility to patients with mental illnesses, and underlying bony structure preventing&#xD;
      unintentional deep insertion. However, more data are needed regarding the rate of drug&#xD;
      absorption and overall safety with etonogestrel implant insertion at this alternative site.&#xD;
&#xD;
      The study will address this knowledge gap by piloting contraceptive implant insertion at this&#xD;
      alternative scapular site among five healthy, reproductive aged women. The investigators will&#xD;
      insert contraceptive implants at this alternative scapular site and conduct serial&#xD;
      measurements of the amount of drug (etonogestrel) circulating in each participant's system&#xD;
      over the course of one year. These measurements will allow us to compare the amount of&#xD;
      circulating drug from the contraceptive implant between this alternative insertion site and&#xD;
      the already published amounts found with standard insertion in the arm. The investigators&#xD;
      will also ask participants about any insertion site related side effects and also general&#xD;
      implant-related side effects (e.g. abnormal bleeding, headaches, weight gain) during the&#xD;
      course of the study. This will provide preliminary side effect data to help us better&#xD;
      understand patient experience with this alternative insertion site. Ultimately, the&#xD;
      investigators hypothesize that this study will provide reassuring data that can support&#xD;
      future larger investigations on this alternative scapular insertion site for the implant.&#xD;
      This alternative insertion site may allow patients who otherwise are not currently candidates&#xD;
      for the most effective hormonal contraceptive method to uptake contraceptive implants in a&#xD;
      safe manner. This research will also allow healthcare providers to discuss an alternative&#xD;
      site for the contraceptive implant for those patients concerned about the potential risks of&#xD;
      deep arm insertion, thus improving patient-centered options for contraceptive implant&#xD;
      provision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 14, 2020</start_date>
  <completion_date type="Actual">February 15, 2022</completion_date>
  <primary_completion_date type="Actual">February 15, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics in the Form of Serum Etonogestrel Concentrations</measure>
    <time_frame>1 week and 12 months</time_frame>
    <description>Serum etonogestrel concentration curves measured over the first year of implant use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Side Effects</measure>
    <time_frame>One and two weeks for &quot;post-insertion site discomfort&quot;, over 12 months for &quot;Amenorrhea&quot;, &quot;Persistent bleeding&quot;, and &quot;Intermittent bleeding&quot;</time_frame>
    <description>Local and systematic side effects associated with etonogestrel contraceptive implant use</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etonogestrel implant</intervention_name>
    <description>Insertion of the contraceptive implant at an alternative insertion site located over the scapula</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindications to etonogestrel implant use based on the US Medical Eligibility&#xD;
             Criteria for Contraceptive use (defined as class 3 or 4 recommendation)18&#xD;
&#xD;
          -  Any known liver conditions that could affect drug metabolism (e.g. cirrhosis,&#xD;
             hepatitis)&#xD;
&#xD;
          -  Currently taking any medications or supplements known to be CYP3A4&#xD;
             inducers/inhibitors19&#xD;
&#xD;
          -  Body-mass index less than 18.5kg/m2 or greater than 30kg/m2&#xD;
&#xD;
          -  Currently pregnant or planning to become pregnant in the next 12 months&#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>
  <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>May 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <results_first_submitted>April 18, 2023</results_first_submitted>
  <results_first_submitted_qc>May 11, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 8, 2023</results_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2023</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>Etonogestrel</mesh_term>
  </intervention_browse>
  <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>June 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT04463693/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Etonogestrel Implant</title>
          <description>Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula&#xD;
Etonogestrel implant: Insertion of the contraceptive implant at an alternative insertion site located over the scapula</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </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="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Etonogestrel Implant</title>
          <description>Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula&#xD;
Etonogestrel implant: Insertion of the contraceptive implant at an alternative insertion site located over the scapula</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </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="26.0" lower_limit="19.6" upper_limit="30.3"/>
                  </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="5"/>
                  </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="1"/>
                  </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="4"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </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="25.0" lower_limit="22.0" upper_limit="28.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics in the Form of Serum Etonogestrel Concentrations</title>
        <description>Serum etonogestrel concentration curves measured over the first year of implant use</description>
        <time_frame>1 week and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Etonogestrel Implant</title>
            <description>Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula&#xD;
Etonogestrel implant: Insertion of the contraceptive implant at an alternative insertion site located over the scapula</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics in the Form of Serum Etonogestrel Concentrations</title>
          <description>Serum etonogestrel concentration curves measured over the first year of implant use</description>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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>
              <title>One-week post insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="511.7" spread="168.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months post-insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136.6" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Side Effects</title>
        <description>Local and systematic side effects associated with etonogestrel contraceptive implant use</description>
        <time_frame>One and two weeks for &quot;post-insertion site discomfort&quot;, over 12 months for &quot;Amenorrhea&quot;, &quot;Persistent bleeding&quot;, and &quot;Intermittent bleeding&quot;</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Etonogestrel Implant</title>
            <description>Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula&#xD;
Etonogestrel implant: Insertion of the contraceptive implant at an alternative insertion site located over the scapula</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Side Effects</title>
          <description>Local and systematic side effects associated with etonogestrel contraceptive implant use</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <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>
              <title>One-week post insertion site discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two-week post insertion site discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amenorrhea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistent bothersome bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intermittent bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Etonogestrel Implant</title>
          <description>Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula&#xD;
Etonogestrel implant: Insertion of the contraceptive implant at an alternative insertion site located over the scapula</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="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="4" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Persistent bothersome uterine bleeding</sub_title>
                <description>One participant reported persistent bothersome bleeding over the course of 12 months after etonogestrel implant insertion. This was an anticipated adverse event</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Intermittent uterine bleeding</sub_title>
                <description>3 out of 5 participants reported intermittent uterine bleeding over the course of 12 months after etonogestrel implant insertion. This was an anticipated adverse event</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>One week post-insertion site discomfort</sub_title>
                <description>4 out 5 participants reported some insertion site discomfort one week after insertion of the etonogestrel implant. This is an anticipated adverse event</description>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="5"/>
              </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/NCT04463693
org study id: 20-0574
nct id: NCT04463693
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will be the first to establish pharmacokinetic curves for the etonogestrel
      contraceptive implant with scapular subdermal insertion. By obtaining this pharmacokinetic
      data, the investigators can compare this data to already published pharmacokinetic data with
      conventional implant insertion. This comparison can provide some reassurance that the
      absorption and distribution of etonogestrel from the contraceptive implant with scapular
      insertion is similar to that found with conventional insertion. With similar pharmacokinetic
      properties, the investigators would expect scapular insertion of the implant to maintain
      similar contraceptive efficacy for the populations of women that may benefit from this
      alternative insertion site. Preliminary safety data will also enrich the understanding of any
      potential insertion site side effects with subdermal scapular implant insertion, as the
      investigators currently only have a single case report with side effect outcomes. The
      investigators can then use this pilot data to support future larger investigations on
      subdermal scapular implant insertion given its complete avoidance of the neurovascular
      complications associated with arm insertion.
The etonogestrel contraceptive implant (Nexplanon®) remains the most effective hormonal
      contraceptive method available in the U.S. The contraceptive implant is routinely inserted
      just beneath the skin on the inner-side of the non-dominant arm, but insertion at this site
      has resulted in rare, yet potentially morbid complications. These complications are due to
      the close proximity of major neurovascular structures (e.g. basilic vein, ulnar nerve) in the
      sulcus between the biceps and triceps muscles. Insertion of the implant deep in the arm has
      resulted in severe complications including migration of the implant into the pulmonary
      vasculature and neurological injury at the time of implant removal. Though these
      complications are rare, their report directly led to changes in the manufacturer's mandatory
      insertion training to move the implant insertion site inferiorly, though it is unlikely that
      this change will completely remove the risk of these rare insertion complications.

      In addition to the rare complications of deep implant insertion in the arm, patients with
      specific medical conditions are also not ideal candidates for this standard insertion site.
      Patients with psychotic illnesses or development delays often require reliable contraception,
      but the arm insertion site for the implant is easily accessible and injuries can result from
      self-removal attempts among these patients. Furthermore, patients with muscular dystrophy
      disorders may not have adequate tissue in this region of the arm to buffer the implant from
      the underlying neurovascular structures. In order to address the needs of these patient
      populations, insertion of the contraceptive implant at an alternative subdermal scapular site
      has been reported in the literature. This insertion just beneath the skin overlying the
      inferior edge of the scapula represents an ideal alternative location for the contraceptive
      implant due to its location far from danger zones of neurovascular structures,
      inaccessibility to patients with mental illnesses, and underlying bony structure preventing
      unintentional deep insertion. However, more data are needed regarding the rate of drug
      absorption and overall safety with etonogestrel implant insertion at this alternative site.

      The study will address this knowledge gap by piloting contraceptive implant insertion at this
      alternative scapular site among five healthy, reproductive aged women. The investigators will
      insert contraceptive implants at this alternative scapular site and conduct serial
      measurements of the amount of drug (etonogestrel) circulating in each participant's system
      over the course of one year. These measurements will allow us to compare the amount of
      circulating drug from the contraceptive implant between this alternative insertion site and
      the already published amounts found with standard insertion in the arm. The investigators
      will also ask participants about any insertion site related side effects and also general
      implant-related side effects (e.g. abnormal bleeding, headaches, weight gain) during the
      course of the study. This will provide preliminary side effect data to help us better
      understand patient experience with this alternative insertion site. Ultimately, the
      investigators hypothesize that this study will provide reassuring data that can support
      future larger investigations on this alternative scapular insertion site for the implant.
      This alternative insertion site may allow patients who otherwise are not currently candidates
      for the most effective hormonal contraceptive method to uptake contraceptive implants in a
      safe manner. This research will also allow healthcare providers to discuss an alternative
      site for the contraceptive implant for those patients concerned about the potential risks of
      deep arm insertion, thus improving patient-centered options for contraceptive implant
      provision.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics in the Form of Serum Etonogestrel Concentrations
time frame: 1 week and 12 months
description: Serum etonogestrel concentration curves measured over the first year of implant use
measure: Number of Participants With Side Effects
time frame: One and two weeks for "post-insertion site discomfort", over 12 months for "Amenorrhea", "Persistent bleeding", and "Intermittent bleeding"
description: Local and systematic side effects associated with etonogestrel contraceptive implant use
arm group label: Intervention
arm group type: Experimental
description: Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula
intervention type: Drug
intervention name: Etonogestrel implant
description: Insertion of the contraceptive implant at an alternative insertion site located over the scapula
arm group label: Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Etonogestrel
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 