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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017139-16 | EudraCT Number |
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The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks, to monitor the increase as well as the "steady state" of the parameters assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Undeconate (Nebido, BAY86-5037) | Drug | Testosterone undecanoate 1000 mg (4 ml) i.m. injection at baseline, at week 6, at week 18, at week 30 and at week 42, respectively |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks | At baseline, at week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| Isometric maximum strength | At baseline, at week 54 | |
| Grip strength | At baseline, at week 54 | |
| Chair raising test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cologne | North Rhine-Westphalia | 50931 | Germany |
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| Label | URL |
|---|---|
| Click here and search for information of Bayer products for Europe | View source |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D043343 | Testosterone Propionate |
| C010792 | testosterone undecanoate |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
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| Placebo | Drug | Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively |
|
| At baseline, at week 54 |
| Arm curl test | At baseline, at week 54 |
| Bicycle stress test with spirometry | At baseline, at week 54 |
| SF-36 Questionnaire | At baseline, at week 54 |
| AMS-Questionnaire | At baseline, at week 54 |
| FINGER Questionnaire | At baseline, at week 54 |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |