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Life Quality and Health in Patients With Klinefelter Syndrome

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01690013
First received: September 11, 2012
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Klinefelter Syndrome
Quality of Life
Physical Disorders
Mental Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Life Quality and Health in Patients With Klinefelter Syndrome - a Questionnaire Survey

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Quality of life score is measured with the WHOQOL-Brief questionnaire

  • Satisfaction with life [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Satisfaction with life is measured with the SWLS - Satisfaction with Life Scale

  • ADHD symptoms [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    ADHD symptoms are measured by Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist

  • General health [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    General health is measured by SF-36 questionnaire

  • Erectile function [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Erectile function is measured by the International index of erectile function (IIEF-5) as a diagnostic tool for erectile function.


Other Outcome Measures:
  • Housing [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Fatherhood [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • School and educational [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Information about school and education

  • Income [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Attachment to the labor [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    working position, working hour, period of sick leave

  • Marital status [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Medication [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Chronic disease [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 1350
Study Start Date: September 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Klinefelter
Men with Klinefelter syndrome
Control
Men from the general population, matched by age, education and zipcode.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690013

Locations
Denmark
Medical Department M, Aarhus Universityhospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Claus H Gravholt, MD, Dr.med. Medical Department M, Aarhus Universityhospital, Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01690013     History of Changes
Other Study ID Numbers: 2012-41-0666
Study First Received: September 11, 2012
Last Updated: September 21, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Klinefelter Syndrome
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
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

ClinicalTrials.gov processed this record on May 23, 2013