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/NCT05988983</url>
    </required_header>
    <id_info>
      <org_study_id>OHSU IRB 14123</org_study_id>
      <nct_id>NCT05988983</nct_id>
    </id_info>
    <brief_title>The Over The Counter Pill National Study</brief_title>
    <official_title>The Over The Counter Pill National Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oregon Health and Science University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Oregon Health and Science University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective cohort study of individuals purchasing the oral contraceptive pill over&#xD;
        the counter (OTC) in pharmacies in 32 US states. The comparison group is people receiving a&#xD;
        prescription (Rx) for oral contraception. Both groups will be followed for one year to&#xD;
        examine contraceptive continuation rates. This study will also identify who is using the pill&#xD;
        OTC and why and evaluate differences in pregnancy intention and measures of contraceptive&#xD;
        agency between the two groups.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2025</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>12 month contraceptive continuation rates</measure>
      <time_frame>12 months</time_frame>
      <description>Difference in proportion of participants using contraception 12 months after starting between over the counter and prescription groups.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">900</enrollment>
    <condition>Contraception</condition>
    <condition>Contraception Behavior</condition>
    <condition>Contraceptive Usage</condition>
    <condition>Health Care Utilization</condition>
    <arm_group>
      <arm_group_label>OTC users</arm_group_label>
      <description>Participants using the oral contraceptive pill purchased over the counter</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Rx users</arm_group_label>
      <description>Participants using the oral contraceptive pill received by a prescription</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Availability of OTC contraceptive pill</intervention_name>
      <description>Over the counter contraceptive pill</description>
      <arm_group_label>OTC users</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Individuals aged 12 to 51 who are obtaining the oral contraceptive pill at a pharmacy for&#xD;
          the purposes of pregnancy prevention.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Capable of pregnancy&#xD;
  &#xD;
            -  Purchasing oral contraception at a participating pharmacy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Using the pill for non contraceptive indications&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>51 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Maria I Rodriguez, MD</last_name>
      <phone>503-494-7921</phone>
      <email>rodrigma@ohsu.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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>Maria Rodriguez, MD, MPH</investigator_full_name>
      <investigator_title>Professor of Obstetrics and Gynecology</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Contraceptive Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05988983
  org study id: OHSU IRB 14123
  nct id: NCT05988983
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective cohort study of individuals purchasing the oral contraceptive pill over
        the counter (OTC) in pharmacies in 32 US states. The comparison group is people receiving a
        prescription (Rx) for oral contraception. Both groups will be followed for one year to
        examine contraceptive continuation rates. This study will also identify who is using the pill
        OTC and why and evaluate differences in pregnancy intention and measures of contraceptive
        agency between the two groups.
  observational model: Cohort
  time perspective: Prospective
  measure: 12 month contraceptive continuation rates
  time frame: 12 months
  description: Difference in proportion of participants using contraception 12 months after starting between over the counter and prescription groups.
  arm group label: OTC users
  description: Participants using the oral contraceptive pill purchased over the counter
  arm group label: Rx users
  description: Participants using the oral contraceptive pill received by a prescription
  intervention type: Other
  intervention name: Availability of OTC contraceptive pill
  description: Over the counter contraceptive pill
  arm group label: OTC users
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 12 Years
  maximum age: 51 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maria I Rodriguez, MD
  phone: 503-494-7921
  email: rodrigma@ohsu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Oregon Health and Science University
  investigator full name: Maria Rodriguez, MD, MPH
  investigator title: Professor of Obstetrics and Gynecology
  mesh term: Contraceptive Agents
  sharing ipd: Undecided