NCT01690013

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 2, 2015

Status Verified

September 1, 2012

Enrollment Period

4 months

First QC Date

September 11, 2012

Last Update Submit

May 31, 2015

Conditions

Klinefelter SyndromeQuality of LifePhysical DisordersMental Disorders

Outcome Measures

Primary Outcomes (5)

  • 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

  • Erectile function

    Erectile function is measured by the International index of erectile function (IIEF-5) as a diagnostic tool for erectile function.

    3 month

Other Outcomes (8)

  • Housing

    3 month

  • Fatherhood

    3 month

  • School and educational

    3 month

  • +5 more other outcomes

Study Arms (2)

Klinefelter

Men with Klinefelter syndrome

Control

Men from the general population, matched by age, education and zipcode.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Verified Klinefelter syndrome

You may not qualify if:

  • none
  • For the control group:
  • age-,educational,and residence-matched
  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Department M, Aarhus Universityhospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Klinefelter SyndromeMental Disorders

Condition Hierarchy (Ancestors)

Sex Chromosome Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSex Chromosome DisordersChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornGonadal DisordersEndocrine System DiseasesHypogonadism

Study Officials

  • Claus H Gravholt, MD, Dr.med.

    Medical Department M, Aarhus Universityhospital, Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 21, 2012

Study Start

September 1, 2012

Primary Completion

January 1, 2013

Study Completion

July 1, 2014

Last Updated

June 2, 2015

Record last verified: 2012-09

Locations

DK(1)