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Psychometric Properties of the German Translation of the Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF)

Conditions
E29.1
Testicular hypofunction
Registration Number
DRKS00013092
Lead Sponsor
Klinik für Psychosomatik und Psychotherapie UKM
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Male
Target Recruitment
174
Inclusion Criteria

adult male patients of the Center of Reproductive Medicine and Andrology, at least 18 years old, who present themselves with different conditions possibly related to hypogonadism

Exclusion Criteria

Exclusion criteria will be current testosterone replacement therapy, current malignancies or severe somatic conditions and Klinefelter syndrome.

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
In order to assess the validity of the HIS-Q-SF, German Version, the 2 Primary endpoints are: <br>1) The correlation between the German version of the HIS-Q-SF total score and the AMS ; <br>2) The correlation between the German version of the HIS-Q-SF total score and free testosterone. <br><br>Two primary hypotheses will be tested in a confirmatory sense:<br>H1: The correlation between the German version of the HIS-Q-SF total score and the AMS total score is greater than 0.5.<br>H2: The correlation between the German version of the HIS-Q-SF total score and free testosterone is negative. <br><br>In order to check the reliability of the HIS-Q-SF (further primary endpoint), the correlation between the first completed HIS-Q-SF and ist repetition within 1 week will be assessed.
Secondary Outcome Measures
NameTimeMethod
Further secondary objectives will be to assess the following correlations: HIS-Q-SF-D-Sexual with AMS-Sexual; HIS-Q-SF-D-Energy with AMS-Somatovegetative; HIS-Q-SF-D-Energy with SF-12-item Vitality; HIS-Q-SF-D-Sleep with AMS-items 04 and 05; HIS-Q-SF-D-mood with AMS-Psychological and PHQ-9 sum score; each particular HIS-Q-SF-D subscale with testosterone; HIS-Q-SF-D-total score and testosterone / CAGn-AR.
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