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Life Quality and Health in Patients With Klinefelter Syndrome

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ClinicalTrials.gov Identifier: NCT01690013
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : June 2, 2015
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:

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.


Condition or disease
Klinefelter Syndrome Quality of Life Physical Disorders Mental Disorders

Study Design
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Study Type : Observational
Actual Enrollment : 452 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Life Quality and Health in Patients With Klinefelter Syndrome - a Questionnaire Survey
Study Start Date : September 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Klinefelter
Men with Klinefelter syndrome
Control
Men from the general population, matched by age, education and zipcode.


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life [ Time Frame: 3 month ]
    Quality of life score is measured with the WHOQOL-Brief questionnaire

  2. Satisfaction with life [ Time Frame: 3 month ]
    Satisfaction with life is measured with the SWLS - Satisfaction with Life Scale

  3. ADHD symptoms [ Time Frame: 3 month ]
    ADHD symptoms are measured by Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist

  4. General health [ Time Frame: 3 month ]
    General health is measured by SF-36 questionnaire

  5. Erectile function [ Time Frame: 3 month ]
    Erectile function is measured by the International index of erectile function (IIEF-5) as a diagnostic tool for erectile function.


Other Outcome Measures:
  1. Housing [ Time Frame: 3 month ]
  2. Fatherhood [ Time Frame: 3 month ]
  3. School and educational [ Time Frame: 3 month ]
    Information about school and education

  4. Income [ Time Frame: 3 month ]
  5. Attachment to the labor [ Time Frame: 3 month ]
    working position, working hour, period of sick leave

  6. Marital status [ Time Frame: 3 month ]
  7. Medication [ Time Frame: 3 month ]
  8. Chronic disease [ Time Frame: 3 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Klinefelter patients is recruited from endocrinology, genetics and fertility clinics in Denmark.

An age-, educational, and zipcode-matched control group was created from Statistics Denmark by extracting five randomly selected men for each KS subject

Criteria

For the Klinefelter group:

Inclusion Criteria:

  • Verified Klinefelter syndrome

Exclusion Criteria:

  • none

For the control group:

Inclusion Criteria:

  • age-,educational,and residence-matched

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690013


Locations
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Denmark
Medical Department M, Aarhus Universityhospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Principal Investigator: Claus H Gravholt, MD, Dr.med. Medical Department M, Aarhus Universityhospital, Aarhus
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01690013     History of Changes
Other Study ID Numbers: 2012-41-0666
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: September 2012
Additional relevant MeSH terms:
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Klinefelter Syndrome
Disease
Syndrome
Mental Disorders
Pathologic Processes
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
 Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism