E29.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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: Exclusion criteria will be current testosterone replacement therapy, current malignancies or severe somatic conditions and Klinefelter syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In order to assess the validity of the HIS-Q-SF, German Version, the 2 Primary endpoints are: 1) The correlation between the German version of the HIS-Q-SF total score and the AMS ; 2) The correlation between the German version of the HIS-Q-SF total score and free testosterone. Two primary hypotheses will be tested in a confirmatory sense: H1: The correlation between the German version of the HIS-Q-SF total score and the AMS total score is greater than 0.5. H2: The correlation between the German version of the HIS-Q-SF total score and free testosterone is negative. 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Klinik für Psychosomatik und Psychotherapie UKM