<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/NCT03299179</url>
  </required_header>
  <id_info>
    <org_study_id>EC/2016/0757</org_study_id>
    <nct_id>NCT03299179</nct_id>
  </id_info>
  <brief_title>The Effects of the Female Hormones on Cerebral Perfusion</brief_title>
  <official_title>The Effects of the Female Sex Hormones and Hormonal Contraception on Cerebral Perfusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Ghent</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>
      Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by&#xD;
      physiological and lifestyle factors. In this study, the investigators want to investigate the&#xD;
      variations in cerebral perfusion and other brain parameters (grey matter, resting-state brain&#xD;
      activity, brain connectivity and white matter diffusion) caused by the female sex hormones&#xD;
      and hormonal contraception.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 3, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Regional cerebral perfusion (ml/100g/min): natural versus contraception</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Differences in regional perfusion between volunteers of the natural cycle group versus the volunteers using contraception</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Regional cerebral perfusion (ml/100g/min) variations during natural menstrual cycle</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Variations in cerebral perfusion during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Regional cerebral perfusion (ml/100g/min) variations during menstrual cycle using contraception</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Variations in cerebral perfusion during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Regional grey matter volume (mm³): natural versus contraception</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Differences in regional grey matter volume between volunteers of the natural cycle group versus the volunteers using contraception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional grey matter volume (mm³) variations during natural menstrual cycle</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Variations during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional grey matter volume (mm³) variations during menstrual cycle using contraception</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Variations in grey matter volume during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting state brain activity: natural versus contraception</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Differences in resting state brain activity between volunteers of the natural cycle group versus the volunteers using contraception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting state brain activity variations during natural menstrual cycle</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Variations in resting state brain activity during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting state brain activity variations during menstrual cycle using contraception</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Variations in resting state brain activity during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral diffusion properties: natural versus contraception</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Differences in diffusion properties (Mean Diffusivity(MD)/Apparent Diffusion Coefficient (ADC)/fractional Anisotropy(FA)) between volunteers of the natural cycle group versus the volunteers using contraception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral diffusion properties variations during natural menstrual cycle</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Variations in diffusion properties (MD/ADC/FA) during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral diffusion properties variations during menstrual cycle using contraception</measure>
    <time_frame>measured during scan-session</time_frame>
    <description>Variations in diffusion properties (MD/ADC/FA) during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Cerebral Perfusion</condition>
  <condition>Contraception</condition>
  <condition>Menstrual Cycle</condition>
  <arm_group>
    <arm_group_label>Natural cycle</arm_group_label>
    <description>15 female volunteers, not using hormonal contraception, will be scanned during 3 menstrual cycles. During each cycle, the volunteers will be scanned 3 times: during the follicular phase, during ovulation and during luteal phase.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anti-conception</arm_group_label>
    <description>15 female volunteers, using hormonal contraception pill Deso 20, will be scanned during 3 menstrual cycles. During each cycle, the volunteers will be scanned 2 times: during the pill-week and during the pill-free week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI scan</intervention_name>
    <description>Several MRI scan modalities: MPRAGE (structural scan), arterial spin labeling (cerebral perfusion), resting state functional-MRI (fMRI, cerebral activity) and diffusion MRI (white matter diffusion and white matter tracts).</description>
    <arm_group_label>Anti-conception</arm_group_label>
    <arm_group_label>Natural cycle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Physiological monitoring</intervention_name>
    <description>During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance</description>
    <arm_group_label>Anti-conception</arm_group_label>
    <arm_group_label>Natural cycle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.</description>
    <arm_group_label>Anti-conception</arm_group_label>
    <arm_group_label>Natural cycle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood pressure measurement</intervention_name>
    <description>Measuring blood pressure before and after MRI-scan</description>
    <arm_group_label>Anti-conception</arm_group_label>
    <arm_group_label>Natural cycle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Body temperature</intervention_name>
    <description>Measuring body temperature before and after MRI-scan</description>
    <arm_group_label>Anti-conception</arm_group_label>
    <arm_group_label>Natural cycle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Questionnaires at the start of the study on lifestyle. Additionally, a questionnaire before each scan session on the actual state of the volunteer (e.g. mood, caffeine consumption, alcohol, medication, etc.)</description>
    <arm_group_label>Anti-conception</arm_group_label>
    <arm_group_label>Natural cycle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pregnancy test</intervention_name>
    <description>Test for pregnancy using a pregnancy dipstick test</description>
    <arm_group_label>Natural cycle</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        30 healthy young volunteers, either using no hormonal anti-conception, either using Deso20&#xD;
        as anti-conception.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bachelor or Master student&#xD;
&#xD;
          -  Minimum of 3 months not using contraception of using Deso20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed consent&#xD;
&#xD;
          -  MRI-contraindications&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Chronic diseases and chronic medication use&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Drug use&#xD;
&#xD;
          -  Abuse of alcohol and caffeine&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Achten, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patricia Clement, Msc</last_name>
    <phone>9 332 1330</phone>
    <phone_ext>+32</phone_ext>
    <email>patricia.clement@ugent.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia Clement, MSc</last_name>
      <phone>477566590</phone>
      <phone_ext>+32</phone_ext>
      <email>patricia.clement@ugent.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03299179
org study id: EC/2016/0757
nct id: NCT03299179
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by
      physiological and lifestyle factors. In this study, the investigators want to investigate the
      variations in cerebral perfusion and other brain parameters (grey matter, resting-state brain
      activity, brain connectivity and white matter diffusion) caused by the female sex hormones
      and hormonal contraception.
observational model: Case-Control
time perspective: Prospective
measure: Regional cerebral perfusion (ml/100g/min): natural versus contraception
time frame: measured during scan-session
description: Differences in regional perfusion between volunteers of the natural cycle group versus the volunteers using contraception
measure: Regional cerebral perfusion (ml/100g/min) variations during natural menstrual cycle
time frame: measured during scan-session
description: Variations in cerebral perfusion during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample
measure: Regional cerebral perfusion (ml/100g/min) variations during menstrual cycle using contraception
time frame: measured during scan-session
description: Variations in cerebral perfusion during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample
measure: Regional grey matter volume (mm³): natural versus contraception
time frame: measured during scan-session
description: Differences in regional grey matter volume between volunteers of the natural cycle group versus the volunteers using contraception
measure: Regional grey matter volume (mm³) variations during natural menstrual cycle
time frame: measured during scan-session
description: Variations during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample
measure: Regional grey matter volume (mm³) variations during menstrual cycle using contraception
time frame: measured during scan-session
description: Variations in grey matter volume during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample
measure: Resting state brain activity: natural versus contraception
time frame: measured during scan-session
description: Differences in resting state brain activity between volunteers of the natural cycle group versus the volunteers using contraception
measure: Resting state brain activity variations during natural menstrual cycle
time frame: measured during scan-session
description: Variations in resting state brain activity during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample
measure: Resting state brain activity variations during menstrual cycle using contraception
time frame: measured during scan-session
description: Variations in resting state brain activity during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample
measure: Cerebral diffusion properties: natural versus contraception
time frame: measured during scan-session
description: Differences in diffusion properties (Mean Diffusivity(MD)/Apparent Diffusion Coefficient (ADC)/fractional Anisotropy(FA)) between volunteers of the natural cycle group versus the volunteers using contraception
measure: Cerebral diffusion properties variations during natural menstrual cycle
time frame: measured during scan-session
description: Variations in diffusion properties (MD/ADC/FA) during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample
measure: Cerebral diffusion properties variations during menstrual cycle using contraception
time frame: measured during scan-session
description: Variations in diffusion properties (MD/ADC/FA) during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample
arm group label: Natural cycle
description: 15 female volunteers, not using hormonal contraception, will be scanned during 3 menstrual cycles. During each cycle, the volunteers will be scanned 3 times: during the follicular phase, during ovulation and during luteal phase.
arm group label: Anti-conception
description: 15 female volunteers, using hormonal contraception pill Deso 20, will be scanned during 3 menstrual cycles. During each cycle, the volunteers will be scanned 2 times: during the pill-week and during the pill-free week.
intervention type: Device
intervention name: MRI scan
description: Several MRI scan modalities: MPRAGE (structural scan), arterial spin labeling (cerebral perfusion), resting state functional-MRI (fMRI, cerebral activity) and diffusion MRI (white matter diffusion and white matter tracts).
arm group label: Anti-conception
arm group label: Natural cycle
intervention type: Device
intervention name: Physiological monitoring
description: During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
arm group label: Anti-conception
arm group label: Natural cycle
intervention type: Biological
intervention name: Blood sample
description: Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
arm group label: Anti-conception
arm group label: Natural cycle
intervention type: Device
intervention name: Blood pressure measurement
description: Measuring blood pressure before and after MRI-scan
arm group label: Anti-conception
arm group label: Natural cycle
intervention type: Device
intervention name: Body temperature
description: Measuring body temperature before and after MRI-scan
arm group label: Anti-conception
arm group label: Natural cycle
intervention type: Other
intervention name: Questionnaires
description: Questionnaires at the start of the study on lifestyle. Additionally, a questionnaire before each scan session on the actual state of the volunteer (e.g. mood, caffeine consumption, alcohol, medication, etc.)
arm group label: Anti-conception
arm group label: Natural cycle
intervention type: Diagnostic Test
intervention name: Pregnancy test
description: Test for pregnancy using a pregnancy dipstick test
arm group label: Natural cycle
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Achten, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Ghent
last name: Patricia Clement, Msc
phone: 9 332 1330
phone ext: +32
email: patricia.clement@ugent.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
sharing ipd: Undecided