<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/NCT03020953</url>
  </required_header>
  <id_info>
    <org_study_id>Estrogen2016</org_study_id>
    <nct_id>NCT03020953</nct_id>
  </id_info>
  <brief_title>The Anabolic Effects of Estrogen on Skeletal Muscles</brief_title>
  <acronym>ESTRO</acronym>
  <official_title>The Anabolic Effects of Estrogen on Skeletal Muscles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: to study the effect of estrogen replacement on muscle hypertrophy in response to 12&#xD;
      weeks resistance training in postmenopausal women Hypothesis: Transdermal administration of&#xD;
      17-β estradiol enhance the anabolic effect of resistance training on muscle mass, strength in&#xD;
      postmenopausal women Primary outcome: Muscle hypertrophy (muscle CSA, muscle fiber type&#xD;
      specific CSA) Secondary outcome: Messenger RiboNucleic Acid (mRNA)(real-time PCR), protein&#xD;
      (western blotting), satellite cell proliferation and activation, Strength, functional test,&#xD;
      muscle protein synthese.&#xD;
&#xD;
      Design: Two groups of healthy postmenopausal women (½-5 years after menopause) who have not&#xD;
      performed regular resistance exercise (&lt;1 times per week) the last two years. Randomized,&#xD;
      controlled intervention study +/- transdermal administration of estrogen (17-β estradiol).&#xD;
      Both groups perform 12 weeks of supervised progressive resistance training (3/week) aiming to&#xD;
      induce muscle hypertrophy in the legs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">February 15, 2018</completion_date>
  <primary_completion_date type="Actual">February 15, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle hypertrophy</measure>
    <time_frame>12 weeks</time_frame>
    <description>muscle cross sectional area measured by Magnetic resonance imaging (MR) -scans</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle fiber hypertrophy</measure>
    <time_frame>12 weeks</time_frame>
    <description>Histology analysis of muscle fiber area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>12 weeks</time_frame>
    <description>Maximal isometric muscle strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tendon size</measure>
    <time_frame>12 weeks</time_frame>
    <description>Tendon cross sectional area measured by MR-scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat cell size</measure>
    <time_frame>12 weeks</time_frame>
    <description>Analysis of fat cell size (diameter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass</measure>
    <time_frame>12 weeks</time_frame>
    <description>Dual-energy X-ray absorptiometry (DXA) scan of total fat mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat free mass</measure>
    <time_frame>12 weeks</time_frame>
    <description>Fat free mass measured by DXA scan</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Estrogen Supplementation</condition>
  <arm_group>
    <arm_group_label>Exercise + Estrogen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Strength training 3 times a week for 12 weeks. Estrogen patches which provide 100 um pr. 24 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise + Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Strength training 3 times a week for 12 weeks. Placebo patches.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise + Estrogen</intervention_name>
    <description>12 weeks resistance training and estrogen patches</description>
    <arm_group_label>Exercise + Estrogen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise + Placebo</intervention_name>
    <description>12 weeks resistance training and placebo patches</description>
    <arm_group_label>Exercise + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women, more than 6 months, but less than 5 years since last&#xD;
             menstruation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 2 hours exercise with moderate to high intensity per week the last year, no&#xD;
             regular resistance exercise the last 2 years (less than 5 exercise bouts during the&#xD;
             last year)&#xD;
&#xD;
          -  No previous or present lower limb injuries which may hinder participation in strength&#xD;
             training&#xD;
&#xD;
          -  No use of medicine which may influence the adaptation to strength training such as&#xD;
             regular use of nonsteroidal anti-inflammatory drugs and use of statins, no muscle&#xD;
&#xD;
          -  Joint or metabolic diseases or other chronic diseases that would affect the results of&#xD;
             the investigation, high blood pressure (&gt;140/90), smoking&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mette Hansen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aarhus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sport Science, Department of Public Health, Aarhus University</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03020953
org study id: Estrogen2016
nct id: NCT03020953
lead sponsor: 
has dmc: Yes
Purpose: to study the effect of estrogen replacement on muscle hypertrophy in response to 12
      weeks resistance training in postmenopausal women Hypothesis: Transdermal administration of
      17-β estradiol enhance the anabolic effect of resistance training on muscle mass, strength in
      postmenopausal women Primary outcome: Muscle hypertrophy (muscle CSA, muscle fiber type
      specific CSA) Secondary outcome: Messenger RiboNucleic Acid (mRNA)(real-time PCR), protein
      (western blotting), satellite cell proliferation and activation, Strength, functional test,
      muscle protein synthese.

      Design: Two groups of healthy postmenopausal women (½-5 years after menopause) who have not
      performed regular resistance exercise (<1 times per week) the last two years. Randomized,
      controlled intervention study +/- transdermal administration of estrogen (17-β estradiol).
      Both groups perform 12 weeks of supervised progressive resistance training (3/week) aiming to
      induce muscle hypertrophy in the legs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Muscle hypertrophy
time frame: 12 weeks
description: muscle cross sectional area measured by Magnetic resonance imaging (MR) -scans
measure: Muscle fiber hypertrophy
time frame: 12 weeks
description: Histology analysis of muscle fiber area
measure: Muscle strength
time frame: 12 weeks
description: Maximal isometric muscle strength
measure: tendon size
time frame: 12 weeks
description: Tendon cross sectional area measured by MR-scan
measure: Fat cell size
time frame: 12 weeks
description: Analysis of fat cell size (diameter)
measure: Fat mass
time frame: 12 weeks
description: Dual-energy X-ray absorptiometry (DXA) scan of total fat mass
measure: Fat free mass
time frame: 12 weeks
description: Fat free mass measured by DXA scan
arm group label: Exercise + Estrogen
arm group type: Experimental
description: Strength training 3 times a week for 12 weeks. Estrogen patches which provide 100 um pr. 24 hours.
arm group label: Exercise + Placebo
arm group type: Active Comparator
description: Strength training 3 times a week for 12 weeks. Placebo patches.
intervention type: Other
intervention name: Exercise + Estrogen
description: 12 weeks resistance training and estrogen patches
arm group label: Exercise + Estrogen
intervention type: Other
intervention name: Exercise + Placebo
description: 12 weeks resistance training and placebo patches
arm group label: Exercise + Placebo
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mette Hansen, PhD
role: Principal Investigator
affiliation: University of Aarhus
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Estrogens