Text Size

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

September 11, 2012
September 21, 2012
September 2012
January 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01690013 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • 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 ]
  • Housing [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Fatherhood [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • School and eduational [ 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 ]
 
Life Quality and Health in Patients With Klinefelter Syndrome
Life Quality and Health in Patients With Klinefelter Syndrome - a Questionnaire Survey

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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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
  • Klinefelter Syndrome
  • Quality of Life
  • Physical Disorders
  • Mental Disorders
Not Provided
  • Klinefelter
    Men with Klinefelter syndrome
  • Control
    Men from the general population, matched by age, education and zipcode.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1350
July 2014
January 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01690013
2012-41-0666
No
University of Aarhus
University of Aarhus
Aarhus University Hospital
Principal Investigator: Claus H Gravholt, MD, Dr.med. Medical Department M, Aarhus Universityhospital, Aarhus
University of Aarhus
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP