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| ID | Type | Description | Link |
|---|---|---|---|
| 306605 | Other Identifier | company internal |
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This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.
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 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone undecanoate (TU) - NebidoTM | Drug | Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and Safety of long term treatment with TU under real-life conditions | Every 3 months during treatment and after final injection |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of treatment satisfaction by patient | 6,10, and 14 injections |
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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 |
|---|---|---|---|---|---|---|
| Nuremberg | Bavaria | 90441 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Behre HM and Elliesen J. Safety and efficacy of intramuscular injections of 1000 mg testosterone undecanoate: A prospective multicenter study in hypogonadal men under conditions resembling real-life situations. Proceedings of the 22nd Annual European Association of Urology (EAU); 2007 Mar 22; Berlin, Germany. Eur Urol Suppl 2007;6(2):108. |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C010792 | testosterone undecanoate |
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| Marburg |
| Hesse |
| 35037 |
| Germany |
| Wolfsburg | Lower Saxony | 38440 | Germany |
| Münster | North Rhine-Westphalia | 48129 | Germany |
| Leipzig | Saxony | 04299 | Germany |
| Halle | Saxony-Anhalt | 06112 | Germany |
| Naumburg | Saxony-Anhalt | 06618 | Germany |
| Berlin | State of Berlin | 10249 | Germany |
| Berlin | State of Berlin | 12159 | Germany |
| Eisenberg | Thuringia | 07607 | Germany |
| Gera | Thuringia | 07551 | Germany |
| Jena | Thuringia | 07740 | Germany |
| Jena | Thuringia | 07743 | Germany |
| Leipzig | 04289 | Germany |