Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction
This study has been completed.
Sponsor:
Bayer
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00681772
First received: April 18, 2008
Last updated: June 16, 2009
Last verified: June 2009
| Tracking Information | |||||
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| First Received Date ICMJE | April 18, 2008 | ||||
| Last Updated Date | June 16, 2009 | ||||
| Start Date ICMJE | March 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
International Index of Erectile Function - Erectile Function Domain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00681772 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction | ||||
| Official Title ICMJE | Open-Label, Multi-Centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction | ||||
| Brief Summary | Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| 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 | Erectile Dysfunction | ||||
| Intervention ICMJE | Drug: Levitra (Vardenafil, BAY38-9456)
5mg, 10mg or 20mg taken 1 hours before sexual intercourse |
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| Study Arm (s) | Experimental: Arm 1
Intervention: Drug: Levitra (Vardenafil, BAY38-9456) |
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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 | 333 | ||||
| Completion Date | November 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00681772 | ||||
| Other Study ID Numbers ICMJE | 100541 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Medical Affairs Therapeutic Area Head, Bayer Healthcare AG | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | GlaxoSmithKline | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | June 2009 | ||||
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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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