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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 26, 2006 | ||||
| Last Updated Date | November 6, 2007 | ||||
| Start Date ICMJE | October 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil. [ Time Frame: 24-128 weeks ] | ||||
| Original Primary Outcome Measures ICMJE |
Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil. | ||||
| Change History | Complete list of historical versions of study NCT00381732 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg. [ Time Frame: 24 weeks ] | ||||
| Original Secondary Outcome Measures ICMJE |
Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharacokinetics of tadalafil 2.5mg and 5mg. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction | ||||
| Official Title ICMJE | A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5mg and 5mg) Administered Once Daily to Men With Erectile Dysfunction | ||||
| Brief Summary | This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Erectile Dysfunction | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 280 | ||||
| Completion Date | June 2006 | ||||
| Primary Completion Date | |||||
| 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 | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00381732 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 7019, H6D-MC-LVFP | ||||
| Study Sponsor ICMJE | Eli Lilly and Company | ||||
| Collaborators ICMJE | ICOS Corporation | ||||
| Investigators ICMJE |
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| Information Provided By | Eli Lilly and Company | ||||
| Verification Date | November 2007 | ||||
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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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