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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001545-15 | EudraCT Number | ||
| 307720 | Other Identifier | Company internal |
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The purpose of this study is to investigate the effect of a testosterone replacement therapy called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and other symptoms of PADAM and safety will be studied.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testogel (Testosterone, BAYV001915) | Drug | 50mg (5g gel sachet), 75mg (5g+2.5g sachet) or 100mg (2x5g sachet) per day applied to the skin of the shoulders, arms or abdomen for 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lean body mass at 6 months | baseline, month 6 and month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total body mass, fat mass and bone density | baseline, month 6 and month 18 | |
| Evaluation of symptoms by the aging males symptoms rating scale | baseline, month 6 and month 18 | |
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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 |
|---|---|---|---|---|---|---|
| Vienna | State of Vienna | 1090 | Austria | |||
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| Placebo | Drug | 5g gel sachet, 5g+2.5g sachet or 2x5g sachets per day applied to the skin of the shoulders, arms or abdomen for 6 months followed by 12 months treatment with testosterone 1% gel as described for arm 1 |
|
| Change in testosterone |
| baseline, month 6 and month 18 |
| Safety parameters | baseline, month 6 and month 18 |
| Graz |
| 8036 |
| Austria |
| Innsbruck | 6020 | Austria |
| Salzburg | 5020 | Austria |
| Vienna | 1021 | Austria |
| Helsinki | 00260 | Finland |
| Oulu | 90100 | Finland |
| Tampere | 33521 | Finland |
| Bonn | North Rhine-Westphalia | 53105 | Germany |
| Dresden | Saxony | 01067 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Halle | Saxony-Anhalt | 06112 | Germany |
| Magdeburg | 39310 | Germany |
| Dublin | Ireland |
| Milan | 20123 | Italy |
| Naples | 80131 | Italy |
| Roma | 00161 | Italy |
| Roma | 00186 | Italy |
| L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Madrid | Madrid | 28007 | Spain |
| Barcelona | 08025 | Spain |
| Gothenburg | 41346 | Sweden |
| Malmö | 20502 | Sweden |
| Stockholm | 14186 | Sweden |
| Reading | Berkshire | RG2 7AG | United Kingdom |
| Wigan | Manchester | WN1 1XX | United Kingdom |
| Cardiff | CF14 5GJ | United Kingdom |
| London | EC1A 7BE | United Kingdom |
| London | NW3 2QG | United Kingdom |
| Sheffield | S5 7AU | United Kingdom |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| 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 |
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