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/NCT05999123</url>
    </required_header>
    <id_info>
      <org_study_id>GH-FH-001</org_study_id>
      <nct_id>NCT05999123</nct_id>
    </id_info>
    <brief_title>Menstrual Cycle Study</brief_title>
    <official_title>Study for the Development of Biometrics-informed Menstrual Cycle Algorithms</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fitbit LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fitbit LLC</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
    </oversight_info>
    <brief_summary>
      <textblock>
        A data collection study to develop algorithms to estimate menstrual cycle phases.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 25, 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</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>Ovulation Day Estimation</measure>
      <time_frame>6 months</time_frame>
      <description>The algorithm's estimated ovulation day compared to the reference urinary ovulation predictor kits (OPK).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Menstruation Day Estimation</measure>
      <time_frame>6 months</time_frame>
      <description>The algorithm's estimated menstruation date(s) compared to participants' self-reported menstruation date(s).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Menstruation</condition>
    <condition>Ovulation</condition>
    <arm_group>
      <arm_group_label>All Participants</arm_group_label>
      <description>Up to 150 participants will be enrolled at one or more clinical research sites in the United States. Participants will be healthy, menstruating individuals between 18 to 42 years of age who meet all eligibility criteria.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy, menstruating individuals between 18 to 42 years of age who meet eligibility&#xD;
          criteria from one or more clinical research sites in the United States.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion:&#xD;
  &#xD;
            -  Adults who are between 18 - 42 years old at enrollment and menstruate&#xD;
  &#xD;
            -  Capable of giving informed consent in Spanish or English&#xD;
  &#xD;
            -  Menstrual cycle lengths between 21- 45 days&#xD;
  &#xD;
            -  Have tracked menstruation for at least 3 menstrual cycles out of the prior 6 months&#xD;
  &#xD;
            -  Willing to wear a wrist-worn wearable device continuously for 6 months&#xD;
  &#xD;
            -  Willing to use an ovulation predictor kit for 6 months&#xD;
  &#xD;
            -  Willing to report vaccine history&#xD;
  &#xD;
            -  Owns a smartphone compatible with the study and has access to wi-fi&#xD;
  &#xD;
          Exclusion:&#xD;
  &#xD;
            -  A citizen of the European Union or United Kingdom&#xD;
  &#xD;
            -  Trying to conceive during the six-month study period&#xD;
  &#xD;
            -  Have used specific forms of birth control in the 3 months prior to the study or&#xD;
               planning on using specific birth control methods during the study duration&#xD;
  &#xD;
            -  Participant has undergone hormonal treatment in the past 3 months or planning to do so&#xD;
               during the study&#xD;
  &#xD;
            -  Known history of health-related issues that affect their menstrual cycle, history of&#xD;
               pelvic radiation, vasomotor symptoms, endometriosis, fibroids, polyps, ovarian cysts&#xD;
               or known history of health-related issues that affect the physiology&#xD;
  &#xD;
            -  Currently (or within the past 3 months) engaged in health impacting behaviors&#xD;
  &#xD;
            -  Have been breastfeeding or pregnant in the past 6 months prior to the study&#xD;
  &#xD;
            -  On medications or taking substances that could affect their menstrual cycle or&#xD;
               physiology&#xD;
  &#xD;
            -  Travel frequently such as crossing more than two time zones at least once every 2&#xD;
               weeks&#xD;
  &#xD;
            -  Have a known sleeping disorder or consistently work night shifts&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>42 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel Johnson, DO</last_name>
      <role>Principal Investigator</role>
      <affiliation>Artemis Institute for Clinical Research</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Artemis Research</last_name>
      <phone>855-367-8834</phone>
      <email>recruitment@artemis-research.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Artemis Headlands LLC (Artemis Institute for Clinical Research)</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92103</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniel Johnson, DO</last_name>
        <phone>858-867-3024</phone>
        <email>Djohnson@artemis-research.com</email>
      </contact>
      <contact_backup>
        <last_name>Emma Thomsen</last_name>
        <phone>858-867-3024</phone>
        <email>ethomsen@artemis-research.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT05999123
  org study id: GH-FH-001
  nct id: NCT05999123
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  A data collection study to develop algorithms to estimate menstrual cycle phases.
  observational model: Cohort
  time perspective: Prospective
  measure: Ovulation Day Estimation
  time frame: 6 months
  description: The algorithm's estimated ovulation day compared to the reference urinary ovulation predictor kits (OPK).
  measure: Menstruation Day Estimation
  time frame: 6 months
  description: The algorithm's estimated menstruation date(s) compared to participants' self-reported menstruation date(s).
  arm group label: All Participants
  description: Up to 150 participants will be enrolled at one or more clinical research sites in the United States. Participants will be healthy, menstruating individuals between 18 to 42 years of age who meet all eligibility criteria.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 42 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Daniel Johnson, DO
  role: Principal Investigator
  affiliation: Artemis Institute for Clinical Research
  last name: Artemis Research
  phone: 855-367-8834
  email: recruitment@artemis-research.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor