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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01690013
Other study ID # 2012-41-0666
Secondary ID
Status Completed
Phase N/A
First received September 11, 2012
Last updated May 31, 2015
Start date September 2012
Est. completion date July 2014

Study information

Verified date September 2012
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 452
Est. completion date July 2014
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility For the Klinefelter group:

Inclusion Criteria:

- Verified Klinefelter syndrome

Exclusion Criteria:

For the control group:

Inclusion Criteria:

- age-,educational,and residence-matched

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
Denmark Medical Department M, Aarhus Universityhospital Aarhus

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Housing 3 month No
Other Fatherhood 3 month No
Other School and educational Information about school and education 3 month No
Other Income 3 month No
Other Attachment to the labor working position, working hour, period of sick leave 3 month No
Other Marital status 3 month No
Other Medication 3 month No
Other Chronic disease 3 month No
Primary Quality of life Quality of life score is measured with the WHOQOL-Brief questionnaire 3 month No
Primary Satisfaction with life Satisfaction with life is measured with the SWLS - Satisfaction with Life Scale 3 month No
Primary ADHD symptoms ADHD symptoms are measured by Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist 3 month No
Primary General health General health is measured by SF-36 questionnaire 3 month No
Primary Erectile function Erectile function is measured by the International index of erectile function (IIEF-5) as a diagnostic tool for erectile function. 3 month No
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