<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/NCT04423055</url>
  </required_header>
  <id_info>
    <org_study_id>1571368</org_study_id>
    <nct_id>NCT04423055</nct_id>
  </id_info>
  <brief_title>Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive</brief_title>
  <acronym>NextOC2</acronym>
  <official_title>Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive: a Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women currently using or starting a combined oral contraceptive (COC) will be offered study&#xD;
      enrollment. Study subjects will have a Nexplanon placed and followed for approximately 12&#xD;
      months to evaluate if they continue the implant, the COC, or both, and to assess bleeding&#xD;
      patterns and adverse events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be conducted at three sites across the United States: University of&#xD;
      California, Davis, University of Colorado and University of Pennsylvania. Investigators will&#xD;
      recruit women currently using COCs or intending to initiate COCs for pregnancy prevention.&#xD;
      Each site will recruit approximately 40 women for a total of 120 subjects.&#xD;
&#xD;
      Visit 1:&#xD;
&#xD;
      Informed consent will be obtained. As part of informed consent, subjects will be educated&#xD;
      that there is little data available on the adverse effects of combined COC and ENG implant&#xD;
      use. The consent form will include a standardized description of the side effects and&#xD;
      bleeding profile of COCs and the implant. Subjects will also need to review the package label&#xD;
      information for Nexplanon and sign the FDA-required Nexplanon consent. After obtaining&#xD;
      informed consent, subjects will be screened for entry criteria. Medical history will be&#xD;
      obtained. A urine pregnancy test will be performed. Eligible subjects will have a Nexplanon&#xD;
      contraceptive implant placed. A diary will be dispensed for the subject to document daily&#xD;
      bleeding, COC use and adverse events.&#xD;
&#xD;
      Follow-up:&#xD;
&#xD;
      Follow up contact will be at approximately 4, 12, 26 and 39 weeks with the exit visit&#xD;
      scheduled at 52 weeks.&#xD;
&#xD;
      At each follow up contact, the diary will be reviewed. Adverse events will be determined by&#xD;
      inquiry and diary review. The subject will inform the study staff if she is using her COC and&#xD;
      if she wants to continue use of her COC and ENG implant. The ENG implant will be removed upon&#xD;
      request at any time during the study.&#xD;
&#xD;
      Study participation will be complete after the 52 week (~ 12 month) exit visit.&#xD;
&#xD;
      No blood draws will occur during this study.&#xD;
&#xD;
      A diary will be used but no surveys will be used.&#xD;
&#xD;
      Data to be collected by study staff include demographics, past medical and gynecologic&#xD;
      history, prior and current contraceptive use.&#xD;
&#xD;
      Because women are being enrolled who are already currently using COCs or who plan to start&#xD;
      COCs, the COC is not a study drug. The study intervention (study drug) is the contraceptive&#xD;
      implant. The systemic hormone exposure with a contraceptive implant is minimal relative to a&#xD;
      COC. The investigators do not expect any increase in side effects by adding a contraceptive&#xD;
      implant to COC users. Of note, the primary risk with COC use is related to the estrogen which&#xD;
      can increase the risk of venous thromboembolic disease. The implant has no estrogen. All&#xD;
      products being used in the study are FDA-approved for contraception.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2024</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Evaluating ENG Implant as Acceptable</measure>
    <time_frame>52 weeks</time_frame>
    <description>Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Evaluating ENG as Tolerable: Tolerability</measure>
    <time_frame>52 weeks</time_frame>
    <description>Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Continuing COC</measure>
    <time_frame>52 weeks</time_frame>
    <description>Continuation of COC over 52 weeks of evaluation regardless of whether or not the implant was still present at 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding Patterns</measure>
    <time_frame>52 weeks</time_frame>
    <description>Bleeding patterns while using a COC concomitantly with ENG implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-study Method Plan</measure>
    <time_frame>52 weeks</time_frame>
    <description>Plan to continue the COC and/or implant after the study based on interview at last visit</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>COC users or new starts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will have an etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users. Women using COC for less than 1 month will be considered new starts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etonogestrel contraceptive implant</intervention_name>
    <description>Place etonogestrel contraceptive implant.</description>
    <arm_group_label>COC users or new starts</arm_group_label>
    <other_name>Nexplanon</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women 18 years and older currently using COCs or who have a COC prescription and are&#xD;
             intending to initiate COCs for contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who have contraindications to using a COC or a contraceptive implant (Category 3&#xD;
             or 4 in the CDC Medical Eligibility Criteria [MEC])&#xD;
&#xD;
          -  Because the CDC MEC are continuously revised, the most updated criteria will be used&#xD;
             (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a3.htm)&#xD;
&#xD;
          -  Women who are currently participating in a clinical trial or have participated within&#xD;
             the past 30 days.&#xD;
&#xD;
          -  Less than 2 weeks from the end of a pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa C Matulich, MD MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Melissa C Matulich, MD MAS</last_name>
    <phone>916-734-6670</phone>
    <email>mcmatulich@ucdavis.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Courtney B Overstreet, BS</last_name>
    <phone>916-734-6846</phone>
    <email>cboverstreet@ucdavis.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California, Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa C Matulich, MD MAS</last_name>
      <phone>916-734-6670</phone>
      <email>mcmatulich@ucdavis.edu</email>
    </contact>
    <contact_backup>
      <last_name>Courtney B Overstreet, BS</last_name>
      <phone>916-734-6846</phone>
      <email>hs-obgynresearch@ucdavis.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Melissa C Matulich, MD MAS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebecca H Cohen, MD MPH</last_name>
      <phone>303-724-2015</phone>
      <email>rebecca.h.cohen@cuanschutz.edu</email>
    </contact>
    <contact_backup>
      <last_name>Eva Dindinger, MPH</last_name>
      <phone>303-724-8482</phone>
      <email>eva.dindinger@cuanschutz.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Rebecca H Cohen, MD MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Roe, MD MPH</last_name>
      <phone>267-254-0225</phone>
      <email>andrea.roe@pennmedicine.upenn.edu</email>
    </contact>
    <contact_backup>
      <last_name>Arden McAllister, MPH</last_name>
      <phone>215-662-3532</phone>
      <email>arden.mcallister@pennmedicine.upenn.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 9, 2023</last_update_submitted>
  <last_update_submitted_qc>June 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Contraceptive implant</keyword>
  <keyword>Nexplanon</keyword>
  <keyword>Combined oral contraceptive</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Contraceptive Agents</mesh_term>
    <mesh_term>Etonogestrel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04423055
org study id: 1571368
nct id: NCT04423055
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Women currently using or starting a combined oral contraceptive (COC) will be offered study
      enrollment. Study subjects will have a Nexplanon placed and followed for approximately 12
      months to evaluate if they continue the implant, the COC, or both, and to assess bleeding
      patterns and adverse events.
This study will be conducted at three sites across the United States: University of
      California, Davis, University of Colorado and University of Pennsylvania. Investigators will
      recruit women currently using COCs or intending to initiate COCs for pregnancy prevention.
      Each site will recruit approximately 40 women for a total of 120 subjects.

      Visit 1:

      Informed consent will be obtained. As part of informed consent, subjects will be educated
      that there is little data available on the adverse effects of combined COC and ENG implant
      use. The consent form will include a standardized description of the side effects and
      bleeding profile of COCs and the implant. Subjects will also need to review the package label
      information for Nexplanon and sign the FDA-required Nexplanon consent. After obtaining
      informed consent, subjects will be screened for entry criteria. Medical history will be
      obtained. A urine pregnancy test will be performed. Eligible subjects will have a Nexplanon
      contraceptive implant placed. A diary will be dispensed for the subject to document daily
      bleeding, COC use and adverse events.

      Follow-up:

      Follow up contact will be at approximately 4, 12, 26 and 39 weeks with the exit visit
      scheduled at 52 weeks.

      At each follow up contact, the diary will be reviewed. Adverse events will be determined by
      inquiry and diary review. The subject will inform the study staff if she is using her COC and
      if she wants to continue use of her COC and ENG implant. The ENG implant will be removed upon
      request at any time during the study.

      Study participation will be complete after the 52 week (~ 12 month) exit visit.

      No blood draws will occur during this study.

      A diary will be used but no surveys will be used.

      Data to be collected by study staff include demographics, past medical and gynecologic
      history, prior and current contraceptive use.

      Because women are being enrolled who are already currently using COCs or who plan to start
      COCs, the COC is not a study drug. The study intervention (study drug) is the contraceptive
      implant. The systemic hormone exposure with a contraceptive implant is minimal relative to a
      COC. The investigators do not expect any increase in side effects by adding a contraceptive
      implant to COC users. Of note, the primary risk with COC use is related to the estrogen which
      can increase the risk of venous thromboembolic disease. The implant has no estrogen. All
      products being used in the study are FDA-approved for contraception.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants Evaluating ENG Implant as Acceptable
time frame: 52 weeks
description: Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
measure: Number of Participants Evaluating ENG as Tolerable: Tolerability
time frame: 52 weeks
description: Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
measure: Number of Participants Continuing COC
time frame: 52 weeks
description: Continuation of COC over 52 weeks of evaluation regardless of whether or not the implant was still present at 52 weeks
measure: Bleeding Patterns
time frame: 52 weeks
description: Bleeding patterns while using a COC concomitantly with ENG implant
measure: Post-study Method Plan
time frame: 52 weeks
description: Plan to continue the COC and/or implant after the study based on interview at last visit
arm group label: COC users or new starts
arm group type: Experimental
description: Subjects will have an etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users. Women using COC for less than 1 month will be considered new starts.
intervention type: Drug
intervention name: Etonogestrel contraceptive implant
description: Place etonogestrel contraceptive implant.
arm group label: COC users or new starts
other name: Nexplanon
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Melissa C Matulich, MD MAS
role: Principal Investigator
affiliation: University of California, Davis
last name: Melissa C Matulich, MD MAS
phone: 916-734-6670
email: mcmatulich@ucdavis.edu
last name: Courtney B Overstreet, BS
phone: 916-734-6846
email: cboverstreet@ucdavis.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Contraceptive Agents
mesh term: Etonogestrel
sharing ipd: No