xml: <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/NCT06000423</url>
    </required_header>
    <id_info>
      <org_study_id>OHSU IRB 25761</org_study_id>
      <nct_id>NCT06000423</nct_id>
    </id_info>
    <brief_title>Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects</brief_title>
    <official_title>Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oregon Health and Science University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bill and Melinda Gates Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Oregon Health and Science University</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This randomized double blinded trial seeks to determine whether tranexamic acid (TXA) is an&#xD;
        efficacious treatment for contraceptive induced menstrual changes (CIMC) including irregular,&#xD;
        bothersome bleeding caused by the etonogestrel subdermal contraceptive implant (ENG implant).&#xD;
        Participants will be randomized into the TXA treatment arm or a placebo. They will begin&#xD;
        taking the medication after three consecutive days of bleeding. Participants will track their&#xD;
        bleeding using an automated text message service&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</primary_completion_date>
    <phase>Phase 4</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>Participants assigned to either the TXA treatment group or the placebo group.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>double-blinded</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Amenorrhea days</measure>
      <time_frame>30 days</time_frame>
      <description>The difference in mean days without bleeding across 30-day reference period between the treatment and placebo groups.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Bleeding</condition>
    <condition>Contraceptive Device; Complications</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After three consecutive days of bleeding, five days of 1300mg TXA three times per day (TID).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>After three consecutive days of bleeding, five days of placebo three times per day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tranexamic acid</intervention_name>
      <description>1300mg TXA taken three times per day for five days</description>
      <arm_group_label>Treatment</arm_group_label>
      <other_name>TXA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo pills taken three times daily for five days.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  English or Spanish speaking&#xD;
  &#xD;
            -  In good general health&#xD;
  &#xD;
            -  Have etonogestrel (ENG) subdermal contraceptive implant (must be palpable to prove&#xD;
               that an ENG implant is in place at time of screening and enrollment)&#xD;
  &#xD;
            -  Experience frequent or prolonged bleeding while using ENG implant (&gt;7 days of&#xD;
               continuous bleeding/spotting in the last 30 days, or 2 or more episodes of&#xD;
               bleeding/spotting in the last 30 days)&#xD;
  &#xD;
            -  Implant use for at least 30 days prior to screening visit&#xD;
  &#xD;
            -  Willing to continue using the implant for at least 30 days from study enrollment&#xD;
  &#xD;
            -  Access to a reliable cell phone and must be willing to receive and respond to a daily&#xD;
               text or email message to assess bleeding and use of study drug&#xD;
  &#xD;
            -  Negative gonorrhea/chlamydia screening performed at screening visit&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Centers for Disease Control Medical Eligibility for Contraceptive use category 3 or 4&#xD;
               for contraceptive usage&#xD;
  &#xD;
            -  Currently pregnant&#xD;
  &#xD;
            -  Less than 6 months postpartum, less than 6 weeks abortion, not breast/chest feeding&#xD;
               (cessation of lactation at least 6 weeks prior to enrollment)&#xD;
  &#xD;
            -  Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant&#xD;
  &#xD;
            -  Bleeding dyscrasia&#xD;
  &#xD;
            -  Anticoagulation use&#xD;
  &#xD;
            -  Active cervicitis&#xD;
  &#xD;
            -  Allergy to Tranexamic Acid&#xD;
  &#xD;
            -  Known renal insufficiency&#xD;
  &#xD;
            -  History of venous thromboembolism&#xD;
  &#xD;
            -  Current or past breast or uterine malignancy&#xD;
  &#xD;
            -  Concurrent use of P450 pathway inducing drug&#xD;
  &#xD;
            -  Implant is due to be switched out in 2 months or less from enrollment&#xD;
  &#xD;
            -  Routine or chronic use of non-steroidal anti-inflammatory drugs (NSAIDs once daily or&#xD;
               &gt;= 14 days per month)&#xD;
  &#xD;
            -  Currently using oral contraceptives in addition to implant (to be eligible, needs to&#xD;
               have 4-6 week washout period)&#xD;
  &#xD;
            -  Prior pregnancy occurred while Nexplanon/Implanon was in place&#xD;
  &#xD;
            -  Chronic use of Cannabidiol, THC, or marijuana (&gt;3 times per week) (patients could have&#xD;
               used Cannabidiol, THC, or marijuana chronically in the past, but must have a washout&#xD;
               time period of no use for at least one month prior to the study)&#xD;
  &#xD;
            -  Chronic use of cigarettes (&gt;1 cigarette per week) (patients could have used cigarettes&#xD;
               chronically in the past, but must have a washout time period of no use for at least&#xD;
               six months prior to the study)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alison Edelman, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Oregon Health and Science University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Leo Han, MD, MCR</last_name>
      <role>Principal Investigator</role>
      <affiliation>Oregon Health and Science University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Women's Health Research Unit Department of Ob/Gyn</last_name>
      <phone>503-494-3666</phone>
      <email>whru@ohsu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Oregon Health &amp; Science University</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97239</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
      <investigator_full_name>Alison Edelman</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Tranexamic Acid</keyword>
    <keyword>Contraceptive Implant</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tranexamic Acid</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000423
  org study id: OHSU IRB 25761
  nct id: NCT06000423
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This randomized double blinded trial seeks to determine whether tranexamic acid (TXA) is an
        efficacious treatment for contraceptive induced menstrual changes (CIMC) including irregular,
        bothersome bleeding caused by the etonogestrel subdermal contraceptive implant (ENG implant).
        Participants will be randomized into the TXA treatment arm or a placebo. They will begin
        taking the medication after three consecutive days of bleeding. Participants will track their
        bleeding using an automated text message service
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants assigned to either the TXA treatment group or the placebo group.
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: double-blinded
  measure: Amenorrhea days
  time frame: 30 days
  description: The difference in mean days without bleeding across 30-day reference period between the treatment and placebo groups.
  arm group label: Treatment
  arm group type: Experimental
  description: After three consecutive days of bleeding, five days of 1300mg TXA three times per day (TID).
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: After three consecutive days of bleeding, five days of placebo three times per day.
  intervention type: Drug
  intervention name: Tranexamic acid
  description: 1300mg TXA taken three times per day for five days
  arm group label: Treatment
  other name: TXA
  intervention type: Other
  intervention name: Placebo
  description: Placebo pills taken three times daily for five days.
  arm group label: Placebo
  criteria: 
  gender: Female
  minimum age: 15 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Alison Edelman, MD, MPH
  role: Principal Investigator
  affiliation: Oregon Health and Science University
  last name: Leo Han, MD, MCR
  role: Principal Investigator
  affiliation: Oregon Health and Science University
  last name: Women's Health Research Unit Department of Ob/Gyn
  phone: 503-494-3666
  email: whru@ohsu.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Oregon Health and Science University
  investigator full name: Alison Edelman
  investigator title: Principal Investigator
  mesh term: Hemorrhage
  mesh term: Tranexamic Acid