NCT01690013|Completed
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Sponsor study identifier
observational
452
1 country
1
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2013
Actual (reported)Study Completion
July 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 11, 2012
Actual (reported)September 21, 2012
Actual (reported)January 2013
Actual (reported)July 2014
Actual (reported)Quality of life
Quality of life score is measured with the WHOQOL-Brief questionnaire
3 month
Satisfaction with life
Satisfaction with life is measured with the SWLS - Satisfaction with Life Scale
3 month
ADHD symptoms
ADHD symptoms are measured by Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist
3 month
General health
General health is measured by SF-36 questionnaire
3 month
Housing
3 month
Fatherhood
3 month
School and educational
3 month
Men with Klinefelter syndrome
Men from the general population, matched by age, education and zipcode.
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
Medical Department M, Aarhus Universityhospital
Aarhus, 8000, Denmark
Claus H Gravholt, MD, Dr.med.
Medical Department M, Aarhus Universityhospital, Aarhus
452 participants (actual enrollment reported by the registry).
First Submitted
September 11, 2012
First Posted
September 21, 2012
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
X-chromosome Inactivation, Epigenetics and the Transcriptome
Erectile function
Erectile function is measured by the International index of erectile function (IIEF-5) as a diagnostic tool for erectile function.
3 month
Contact the study team to confirm eligibility.
Primary Completion
January 2013
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
June 2, 2015
Record last verified: 2012-09
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Source: ClinicalTrials.gov.
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