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/NCT05967819</url>
    </required_header>
    <id_info>
      <org_study_id>CRCW FHA</org_study_id>
      <nct_id>NCT05967819</nct_id>
    </id_info>
    <brief_title>Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women</brief_title>
    <acronym>FHA</acronym>
    <official_title>Independent and Synergistic Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Colorado, Colorado Springs</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Colorado, Colorado Springs</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to determine how changes in exercise and psychosocial&#xD;
        stress may influence the risk of menstrual cycle irregularities in female runners. The main&#xD;
        questions it aims to answer are:&#xD;
  &#xD;
          -  Does the implementation of exercise or psychosocial stress effect circulating&#xD;
             reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual&#xD;
             cycle length?&#xD;
  &#xD;
          -  Is there an additive effect of combined exercise and psychosocial on circulating&#xD;
             reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual&#xD;
             cycle length?&#xD;
  &#xD;
        Participants will be asked to do the following over the ~3 month enrollment period:&#xD;
  &#xD;
          -  attend a laboratory visit at the beginning and end of the study to have their resting&#xD;
             metabolic rate, aerobic fitness, and body composition tested&#xD;
  &#xD;
          -  monitor their menstrual cycle length, daily perceived stress levels, physical activity,&#xD;
             and diet each month&#xD;
  &#xD;
          -  provide several urine and saliva samples each month&#xD;
  &#xD;
          -  either maintain their usual physical activity and lifestyle habits (control group),&#xD;
             increase the duration of their weekly running mileage by 30% (exercise stress group),&#xD;
             complete cognitive function tasks designed to be stressful (psychosocial stress group),&#xD;
             or increase the duration of their weekly running mileage by 30% and complete cognitive&#xD;
             function tasks designed to be stressful (exercise + psychosocial stress group) during&#xD;
             the final month of enrollment.&#xD;
  &#xD;
        Researchers will compare control, exercise stress, psychosocial stress, and exercise +&#xD;
        psychosocial stress groups to see if there is an effect on circulating reproductive hormones&#xD;
        (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Factorial Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Urinary estrone-3-glucuronide (E3G)</measure>
      <time_frame>3 months</time_frame>
      <description>ng/mL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Urinary pregnanediol glucuronide (PdG)</measure>
      <time_frame>3 months</time_frame>
      <description>ug/mL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Urinary luteinizing hormone (LH)</measure>
      <time_frame>3 months</time_frame>
      <description>MIU/mL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Menstrual cycle length</measure>
      <time_frame>3 months</time_frame>
      <description>days</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Amenorrhea Secondary</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants will be asked to maintain their usual physical activity and lifestyle habits.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exercise Stress</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The duration of participant's weekly running mileage will be increased by 30% while intensity is maintained.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Psychosocial Stress</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be asked to complete cognitive function tasks designed to be stressful while maintaining their usual physical activity habits.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exercise + Psychosocial Stress</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be asked to complete cognitive function tasks designed to be stressful while the duration of their weekly running mileage is increased by 30% and intensity maintained.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exercise Stress</intervention_name>
      <description>Increased exercise volume</description>
      <arm_group_label>Exercise + Psychosocial Stress</arm_group_label>
      <arm_group_label>Exercise Stress</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Psychosocial Stress</intervention_name>
      <description>cognitive tasks</description>
      <arm_group_label>Exercise + Psychosocial Stress</arm_group_label>
      <arm_group_label>Psychosocial Stress</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  have participated in structured running exercise at least 4 days per week, completing&#xD;
               at least 30 miles per week, for the past 12 months&#xD;
  &#xD;
            -  can complete a 5-km race in less than 25:00&#xD;
  &#xD;
            -  have regular periods every 21 to 35 days&#xD;
  &#xD;
            -  have not used hormonal contraceptives for at least the past 6 months&#xD;
  &#xD;
            -  are not currently or trying to become pregnant or are breastfeeding, and have not been&#xD;
               pregnant or breastfeeding for the past 12 months&#xD;
  &#xD;
            -  have never been diagnosed with a menstrual cycle disorder (e.g., menorrhagia,&#xD;
               amenorrhea, dysmenorrhea, polycystic ovary syndrome [PCOS], endometriosis,&#xD;
               premenstrual dysphoric disorder [PMDD], menstrual migraines, ovarian cancer, ovarian&#xD;
               insufficiency, uterine or endometrial cancer)&#xD;
  &#xD;
            -  have never been diagnosed with a metabolic disease (e.g., hypothyroidism,&#xD;
               hyperthyroidism, Cushing disease, Addison's disease, diabetes)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  missing &gt; 4 consecutive days of structured running exercise&#xD;
  &#xD;
            -  they indicate they &quot;Could not participate at all due to a health problem&quot; or have had&#xD;
               to modify their exercise training, felt their injury, illness, or other health problem&#xD;
               has affected their exercise performance, or experienced symptoms/ health complaints&#xD;
               greater than &quot;To a minor extent&quot; on the Oslo Sports Trauma Research Center&#xD;
               Questionnaire (exercise training intervention group)&#xD;
  &#xD;
            -  demonstrate clinical low energy availability as defined as energy availability &lt;30&#xD;
               Kcal/kg fat free mass in the first two months of at-home monitoring&#xD;
  &#xD;
            -  report menstrual cycle lengths &lt;21 days or &gt;35 days in the first two months of at-home&#xD;
               monitoring&#xD;
  &#xD;
            -  do not demonstrate an anticipated rise in progesterone levels during the latter half&#xD;
               of their cycle or luteinizing hormone levels at mid-cycle compared to tests taken&#xD;
               during the first few days after menses in the first two months of at-home monitoring&#xD;
  &#xD;
            -  begin taking a hormonal contraceptive&#xD;
  &#xD;
            -  become pregnant&#xD;
  &#xD;
            -  are diagnosed with a menstrual cycle disorder (e.g., menorrhagia, amenorrhea,&#xD;
               dysmenorrhea, polycystic ovary syndrome [PCOS], endometriosis, premenstrual dysphoric&#xD;
               disorder [PMDD], menstrual migraines, ovarian cancer, ovarian insufficiency, uterine&#xD;
               or endometrial cancer)&#xD;
  &#xD;
            -  are diagnosed with a metabolic disease (e.g., hypothyroidism, hyperthyroidism, Cushing&#xD;
               disease, Addison's disease, diabetes), 10) are diagnosed with a major cardiovascular&#xD;
               disease, respiratory disease, or musculoskeletal injury&#xD;
  &#xD;
            -  are unable to follow instructions for any of the procedures&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Marissa Baranauskas, PhD</last_name>
      <phone>719-255-4475</phone>
      <email>mbaranau@uccs.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kristen Rudd, PhD</last_name>
      <email>krudd@uccs.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Colorado Colorado Springs</name>
        <address>
          <city>Colorado Springs</city>
          <state>Colorado</state>
          <zip>80918</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marissa Baranauskas, PhD</last_name>
        <phone>719-255-4475</phone>
        <email>mbaranau@uccs.edu</email>
      </contact>
      <contact_backup>
        <last_name>Kristen Rudd, PhD</last_name>
        <email>krudd@uccs.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Marissa Baranauskas, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kristen Rudd, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Colorado, Colorado Springs</investigator_affiliation>
      <investigator_full_name>Marissa Baranauskas</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>functional hypothalamic amenorrhea</keyword>
    <keyword>menstrual cycle</keyword>
    <keyword>female athlete</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Amenorrhea</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05967819
  org study id: CRCW FHA
  nct id: NCT05967819
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to determine how changes in exercise and psychosocial
        stress may influence the risk of menstrual cycle irregularities in female runners. The main
        questions it aims to answer are:
  
          -  Does the implementation of exercise or psychosocial stress effect circulating
             reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual
             cycle length?
  
          -  Is there an additive effect of combined exercise and psychosocial on circulating
             reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual
             cycle length?
  
        Participants will be asked to do the following over the ~3 month enrollment period:
  
          -  attend a laboratory visit at the beginning and end of the study to have their resting
             metabolic rate, aerobic fitness, and body composition tested
  
          -  monitor their menstrual cycle length, daily perceived stress levels, physical activity,
             and diet each month
  
          -  provide several urine and saliva samples each month
  
          -  either maintain their usual physical activity and lifestyle habits (control group),
             increase the duration of their weekly running mileage by 30% (exercise stress group),
             complete cognitive function tasks designed to be stressful (psychosocial stress group),
             or increase the duration of their weekly running mileage by 30% and complete cognitive
             function tasks designed to be stressful (exercise + psychosocial stress group) during
             the final month of enrollment.
  
        Researchers will compare control, exercise stress, psychosocial stress, and exercise +
        psychosocial stress groups to see if there is an effect on circulating reproductive hormones
        (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length.
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Urinary estrone-3-glucuronide (E3G)
  time frame: 3 months
  description: ng/mL
  measure: Urinary pregnanediol glucuronide (PdG)
  time frame: 3 months
  description: ug/mL
  measure: Urinary luteinizing hormone (LH)
  time frame: 3 months
  description: MIU/mL
  measure: Menstrual cycle length
  time frame: 3 months
  description: days
  arm group label: Control
  arm group type: No Intervention
  description: Participants will be asked to maintain their usual physical activity and lifestyle habits.
  arm group label: Exercise Stress
  arm group type: Experimental
  description: The duration of participant's weekly running mileage will be increased by 30% while intensity is maintained.
  arm group label: Psychosocial Stress
  arm group type: Experimental
  description: Participants will be asked to complete cognitive function tasks designed to be stressful while maintaining their usual physical activity habits.
  arm group label: Exercise + Psychosocial Stress
  arm group type: Experimental
  description: Participants will be asked to complete cognitive function tasks designed to be stressful while the duration of their weekly running mileage is increased by 30% and intensity maintained.
  intervention type: Behavioral
  intervention name: Exercise Stress
  description: Increased exercise volume
  arm group label: Exercise + Psychosocial Stress
  arm group label: Exercise Stress
  intervention type: Behavioral
  intervention name: Psychosocial Stress
  description: cognitive tasks
  arm group label: Exercise + Psychosocial Stress
  arm group label: Psychosocial Stress
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marissa Baranauskas, PhD
  phone: 719-255-4475
  email: mbaranau@uccs.edu
  last name: Kristen Rudd, PhD
  email: krudd@uccs.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Colorado, Colorado Springs
  investigator full name: Marissa Baranauskas
  investigator title: Assistant Professor
  mesh term: Amenorrhea
  sharing ipd: No