<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/NCT01690013</url>
  </required_header>
  <id_info>
    <org_study_id>2012-41-0666</org_study_id>
    <nct_id>NCT01690013</nct_id>
  </id_info>
  <brief_title>Life Quality and Health in Patients With Klinefelter Syndrome</brief_title>
  <official_title>Life Quality and Health in Patients With Klinefelter Syndrome - a Questionnaire Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Klinefelter syndrome is the most common sex-chromosome disorder in men with a prevalence of 1&#xD;
      in 660 men. The syndrome is associated with hypogonadism. Many patients with Klinefelter&#xD;
      syndrome have psychological complaints and physical discomfort. Some patients report a&#xD;
      positive effect of testosterone treatment, whereas others do not.&#xD;
&#xD;
      The aim of this study is:&#xD;
&#xD;
      (i) To investigate quality of life in patients with Klinefelter syndrome. (ii) To investigate&#xD;
      functional, physical and mental health in patients with Klinefelter syndrome.&#xD;
&#xD;
      Questionnaire concerning mental and physical health and life quality are sent out to patients&#xD;
      with KS and to age-, educational- and zipcode-matched men from the general population. The&#xD;
      questionnaire include questions about housing, income, marital status, fatherhood,&#xD;
      medication, chronic disease,school and education, attachment to the labor, sexual and&#xD;
      erectile function, life quality, mental and physical health, satisfaction with life and&#xD;
      symptoms of attention deficits hyperactivity disorders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>3 month</time_frame>
    <description>Quality of life score is measured with the WHOQOL-Brief questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with life</measure>
    <time_frame>3 month</time_frame>
    <description>Satisfaction with life is measured with the SWLS - Satisfaction with Life Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ADHD symptoms</measure>
    <time_frame>3 month</time_frame>
    <description>ADHD symptoms are measured by Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General health</measure>
    <time_frame>3 month</time_frame>
    <description>General health is measured by SF-36 questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Erectile function</measure>
    <time_frame>3 month</time_frame>
    <description>Erectile function is measured by the International index of erectile function (IIEF-5) as a diagnostic tool for erectile function.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Housing</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fatherhood</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>School and educational</measure>
    <time_frame>3 month</time_frame>
    <description>Information about school and education</description>
  </other_outcome>
  <other_outcome>
    <measure>Income</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Attachment to the labor</measure>
    <time_frame>3 month</time_frame>
    <description>working position, working hour, period of sick leave</description>
  </other_outcome>
  <other_outcome>
    <measure>Marital status</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Medication</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Chronic disease</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">452</enrollment>
  <condition>Klinefelter Syndrome</condition>
  <condition>Quality of Life</condition>
  <condition>Physical Disorders</condition>
  <condition>Mental Disorders</condition>
  <arm_group>
    <arm_group_label>Klinefelter</arm_group_label>
    <description>Men with Klinefelter syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Men from the general population, matched by age, education and zipcode.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Klinefelter patients is recruited from endocrinology, genetics and fertility clinics in&#xD;
        Denmark.&#xD;
&#xD;
        An age-, educational, and zipcode-matched control group was created from Statistics Denmark&#xD;
        by extracting five randomly selected men for each KS subject&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For the Klinefelter group:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Verified Klinefelter syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
&#xD;
        For the control group:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  age-,educational,and residence-matched&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claus H Gravholt, MD, Dr.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Department M, Aarhus Universityhospital, Aarhus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Department M, Aarhus Universityhospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>May 31, 2015</last_update_submitted>
  <last_update_submitted_qc>May 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Klinefelter Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_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/NCT01690013
org study id: 2012-41-0666
nct id: NCT01690013
lead sponsor: 
collaborator: 
has dmc: No
Klinefelter syndrome is the most common sex-chromosome disorder in men with a prevalence of 1
      in 660 men. The syndrome is associated with hypogonadism. Many patients with Klinefelter
      syndrome have psychological complaints and physical discomfort. Some patients report a
      positive effect of testosterone treatment, whereas others do not.

      The aim of this study is:

      (i) To investigate quality of life in patients with Klinefelter syndrome. (ii) To investigate
      functional, physical and mental health in patients with Klinefelter syndrome.

      Questionnaire concerning mental and physical health and life quality are sent out to patients
      with KS and to age-, educational- and zipcode-matched men from the general population. The
      questionnaire include questions about housing, income, marital status, fatherhood,
      medication, chronic disease,school and education, attachment to the labor, sexual and
      erectile function, life quality, mental and physical health, satisfaction with life and
      symptoms of attention deficits hyperactivity disorders.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Quality of life
time frame: 3 month
description: Quality of life score is measured with the WHOQOL-Brief questionnaire
measure: Satisfaction with life
time frame: 3 month
description: Satisfaction with life is measured with the SWLS - Satisfaction with Life Scale
measure: ADHD symptoms
time frame: 3 month
description: ADHD symptoms are measured by Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist
measure: General health
time frame: 3 month
description: General health is measured by SF-36 questionnaire
measure: Erectile function
time frame: 3 month
description: Erectile function is measured by the International index of erectile function (IIEF-5) as a diagnostic tool for erectile function.
measure: Housing
time frame: 3 month
measure: Fatherhood
time frame: 3 month
measure: School and educational
time frame: 3 month
description: Information about school and education
measure: Income
time frame: 3 month
measure: Attachment to the labor
time frame: 3 month
description: working position, working hour, period of sick leave
measure: Marital status
time frame: 3 month
measure: Medication
time frame: 3 month
measure: Chronic disease
time frame: 3 month
arm group label: Klinefelter
description: Men with Klinefelter syndrome
arm group label: Control
description: Men from the general population, matched by age, education and zipcode.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claus H Gravholt, MD, Dr.med.
role: Principal Investigator
affiliation: Medical Department M, Aarhus Universityhospital, Aarhus
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Klinefelter Syndrome
mesh term: Syndrome
mesh term: Mental Disorders