Hypogonadism
Conditions
Keywords
Hypogonadism, Testosterone, Substitution
Brief summary
The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff.
Detailed description
The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff (TGW). A minimum of 100 patients will be recruited and evenly distributed to two treatment arms. 1st arm: dermal (non-scrotal) application of TGW. 2nd arm: scrotal application of TGW.
Interventions
DRUGTestosterone Gel Wolff
Sponsors
Dr. August Wolff GmbH & Co. KG Arzneimittel
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
men with * hypergonadotropic hypogonadism * hypogonadotropic hypogonadism * late-onset hypogonadism combined with an initial Testosterone serum level of \< 11 nmol/l
Exclusion criteria
* known or suspected carcinoma of the prostate * clinically relevant abnormalities in clinical chemistry or haematology * any severe medical conditions at the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| testosterone levels | — |
Secondary
| Measure | Time frame |
|---|---|
| compliance (drug accountability) | — |
| hormones | — |
| sexual function and mood disorder (questionnaire) | — |
Countries
Germany
Outcome results
None listed