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NCT Number: NCT01690013

Life Quality and Health in Patients With Klinefelter Syndrome

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.

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Key information

Conditions

Klinefelter Syndrome Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Hypogonadism Male Urogenital Diseases Mental Disorders Physical Disorders Quality of Life Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Urogenital Abnormalities Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Medical Department M, Aarhus Universityhospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

Life Quality and Health in Patients With Klinefelter Syndrome - a Questionnaire Survey

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Sep 21, 2012
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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