Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00220298
First received: September 16, 2005
Last updated: January 22, 2013
Last verified: January 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 16, 2005 | ||||
| Last Updated Date | January 22, 2013 | ||||
| Start Date ICMJE | February 2003 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Efficacy and Safety of long term treatment with TU under real-life conditions [ Time Frame: Every 3 months during treatment and after final injection ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Efficacy and Safety of long term treatment with TU under real-life conditions | ||||
| Change History | Complete list of historical versions of study NCT00220298 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Assessment of treatment satisfaction by patient [ Time Frame: 6,10, and 14 injections ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Assessment of treatment satisfaction by patient | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism | ||||
| Official Title ICMJE | Open One-arm Study to Investigate Safety and Efficacy of Intramuscular Injections of 1000 mg Testosterone Undecanoate (TU) in Hypogonadal Men at Variable Intervals During a 136-week to 192-week Treatment Including Pharmacokinetics | ||||
| Brief Summary | This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations. |
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| Detailed Description | 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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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Hypogonadism | ||||
| Intervention ICMJE | Drug: Testosterone undecanoate (TU) - NebidoTM
Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals |
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| Study Arm (s) | Experimental: Arm 1
Intervention: Drug: Testosterone undecanoate (TU) - NebidoTM |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 161 | ||||
| Completion Date | October 2007 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00220298 | ||||
| Other Study ID Numbers ICMJE | 91186, 306605 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Therapeutic Area Head, Bayer Healthcare AG | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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