Tracking Information
Start Date ICMJE | October 2006 |
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Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: August 31, 2009) | Adverse events, adverse drug reactions, patient reported tolerability [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: November 3, 2008) | Adverse events, adverse drug reactions, patient reported tolerability [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ] |
Change History | Complete list of historical versions of study NCT00410306 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: August 31, 2009) |
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Original Secondary Outcome Measures ICMJE (submitted: November 3, 2008) |
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Descriptive Information
Brief Title ICMJE | Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice |
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Official Title ICMJE | International, Multi-center Post Authorization Surveillance Study on the Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice (IPASS Nebido) |
Brief Summary | This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice. |
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. |
Study Phase | |
Study Type ICMJE | Observational |
Study Design ICMJE | Cohort, Prospective |
Condition ICMJE |
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Intervention ICMJE | Drug: Testosterone Undecanoate (Nebido, BAY86-5037) Patients from routine practice |
Study Arms / Comparison Groups | Group 1 Intervention: Drug: Testosterone Undecanoate (Nebido, BAY86-5037) |
Recruitment Information
Estimated Enrollment ICMJE | 1500 | ||||
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Estimated Completion Date | June 2010 | ||||
Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: - Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization Exclusion Criteria: - Patients presenting with contraindications as stated in the product information | ||||
Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Australia, Austria, Bosnia and Herzegovina, Bulgaria, Colombia, Czech Republic, Estonia, Germany, Hong Kong, Indonesia, Italy, Jordan, Kazakhstan, Korea, Republic of, Latvia, Lebanon, Lithuania, Macedonia, The Former Yugoslav Republic of, Malaysia, Malta, Mexico, Moldova, Republic of, Philippines, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00410306 | ||||
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Responsible Party | Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG | ||||
Study ID Numbers ICMJE | 14203, 2005/00888, MP-04199, NE0601 | ||||
Study Sponsor ICMJE | Bayer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Bayer |