There will not be any special medical condition under investigation.Only healthy volunteers will be included in this clinical trial.
Conditions
Interventions
Trade Name: Testogel 50 mg Gel im Beutel
Product Name: Testogel 50 mg Gel im Beutel
Pharmaceutical Form: Gel
Sponsors
German Sport University Cologne, Institute of CArdiology and Sports Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: voluntary, healthy, eugonadale men between 18-40 years old (medical history, physical examinations, hematologic tests, and blood and urine evaluations without pathologic findings) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: hypogonadism, carcinoma of the breast or known or suspected carcinoma of the prostate, abuse of androgens, hypertension, cardiac, hepatic or renal insufficiency, ischaemic heart disease, epilepsy, migraine, obesity, chronic respiratory disease, drug or alcohol abuse, taking of any other drugs, known hypersensitivity to testosterone substance or to any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of effects of trandermal testosterone application to eugonadal men reagrding urinary steroid profiles and the integrity of the hypothalamo-pituitary-gonadale axis (especially secretion of LH, FSH, and testosterone).;Secondary Objective: Development of an endocrine test for the indirect detection of testosterone gel misuse in sport.;Primary end point(s): End after the 9-week treatment/monitoring period. | — |
Countries
Germany
Outcome results
None listed