Endocrine study on the effects of testosterone gel application in male athletes
- Conditions
- There will not be any special medical condition under investigation.Only healthy volunteers will be included in this clinical trial.
- Registration Number
- EUCTR2005-001453-22-DE
- Lead Sponsor
- German Sport University Cologne, Institute of CArdiology and Sports Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 16
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method