<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/NCT03832972</url>
  </required_header>
  <id_info>
    <org_study_id>Estrogen2018</org_study_id>
    <nct_id>NCT03832972</nct_id>
  </id_info>
  <brief_title>Performance During Menstrual Cycle</brief_title>
  <official_title>Variation in Performance During Menstrual Cycle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Team Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This project aims to investigate if muscle strength and muscle power fluctuate during the&#xD;
      menstrual cycle.&#xD;
&#xD;
      The hypothesis is that the greatest performance will be measured right before ovulation, and&#xD;
      at it's lowest on day 1 and 2 of the menstrual cycle in women not using any form for hormonal&#xD;
      protection.&#xD;
&#xD;
      And that the performance in women using birth control pills, not will variated in the period&#xD;
      where they are taking pills (day 1-21).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in jumping height</measure>
    <time_frame>8 times per month, 2 to 5 days between measurements</time_frame>
    <description>measuring of change in muscle power</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in grip strength</measure>
    <time_frame>8 times per month, 2 to 5 days between measurements</time_frame>
    <description>measuring of changes in muscle strength</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in hormone levels</measure>
    <time_frame>8 time per month, 2 to 5 days between measurements</time_frame>
    <description>measuring of changes in hormone levels during cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in motivation by questionnaire</measure>
    <time_frame>8 times per month, 2 to 5 days between measurements</time_frame>
    <description>measuring of changes in motivation for performing</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Performance</condition>
  <arm_group>
    <arm_group_label>Women using birth control</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Women not using birthcontrol</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>estrogen level</intervention_name>
    <description>Women are tested at different times in their menstrual cycle, if there is a cohesion between performance and level of estrogen</description>
    <arm_group_label>Women not using birthcontrol</arm_group_label>
    <arm_group_label>Women using birth control</arm_group_label>
    <other_name>Physical tests</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy women, 10 using 2. generations birth control pills and 30 not using any kind of&#xD;
        hormonal protection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  18-35 years of age&#xD;
&#xD;
          -  BMI 18.5-25.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  hormonal or metabolic disorders&#xD;
&#xD;
          -  chronic sickness&#xD;
&#xD;
          -  use of medication&#xD;
&#xD;
          -  breast feeding, vegetarians&#xD;
&#xD;
          -  diet containing a lot of soja based products&#xD;
&#xD;
          -  injuries which make it impossible to do the tests&#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>
  <location>
    <facility>
      <name>Section of Sport Science</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>October 22, 2018</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>menstrual cycle</keyword>
  <keyword>Estrogen</keyword>
  <keyword>performance</keyword>
  <keyword>variation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estrogens</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03832972
org study id: Estrogen2018
nct id: NCT03832972
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project aims to investigate if muscle strength and muscle power fluctuate during the
      menstrual cycle.

      The hypothesis is that the greatest performance will be measured right before ovulation, and
      at it's lowest on day 1 and 2 of the menstrual cycle in women not using any form for hormonal
      protection.

      And that the performance in women using birth control pills, not will variated in the period
      where they are taking pills (day 1-21).
observational model: Cohort
time perspective: Cross-Sectional
measure: Change in jumping height
time frame: 8 times per month, 2 to 5 days between measurements
description: measuring of change in muscle power
measure: Change in grip strength
time frame: 8 times per month, 2 to 5 days between measurements
description: measuring of changes in muscle strength
measure: Change in hormone levels
time frame: 8 time per month, 2 to 5 days between measurements
description: measuring of changes in hormone levels during cycle
measure: Change in motivation by questionnaire
time frame: 8 times per month, 2 to 5 days between measurements
description: measuring of changes in motivation for performing
arm group label: Women using birth control
arm group label: Women not using birthcontrol
intervention type: Other
intervention name: estrogen level
description: Women are tested at different times in their menstrual cycle, if there is a cohesion between performance and level of estrogen
arm group label: Women not using birthcontrol
arm group label: Women using birth control
other name: Physical tests
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Estrogens