Evaluation of LEVITRA to Advance the Treatment of Erectile Dysfunction
|First Received Date ICMJE||April 18, 2008|
|Last Updated Date||June 16, 2009|
|Start Date ICMJE||May 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Effect of education of the primary care physician or of the subject, in treating erectile dysfunction with vardenafil, relative to usual care, on the subject's treatment outcome of ED and quality of life. [ 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 NCT00664833 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of LEVITRA to Advance the Treatment of Erectile Dysfunction|
|Official Title ICMJE||An Open-Label, Multi-Center, Factorial Design, Cluster-Randomized Clinical Study of Vardenafil in Canadian Males With Erectile Dysfunction: Impact of Education of the Primary Care Physician and Patient on Patient Outcomes.|
This is a multicentre, cluster-randomized, open-label flexible dose study with a 2x2 factorial design with administration of vardenafil at a dose of 5, 10 and 20 mg doses in males with erectile dysfunction.
The treatment period is for 12 weeks, after a 4 week unmedicated period for subjects taking ED medication. For ED treatment-naïve subjects (ie, previously not treated with ED medication), the unmedicated period can be only 2 weeks.
Approximately 150 investigational centres may be utilised with approximately 10 subjects screened and entered into a 4 week treatment free period at Visit 1 to subsequently enroll approximately 1380 subjects to therapy. Each centre should enroll 10 subjects. Sites should try to recruit approximately 50% of subjects who have not previously tried oral PDE5 inhibitor therapy for erectile dysfunction. An attempt should be made to enroll subjects whose partners are interested in being involved.
Sites will be randomized in a 1:1:1:1 ratio to receive either the education intervention at the Primary care Physician (PCP) level, at the subject level, both levels or no intervention (usual care).
The PCP education program is an accredited CME program and included a comprehensive overview on the screening and diagnosis of ED, the available treatment options and appropriate treatment selection, as well as subject and partner counseling. The subject education was a two-pronged approach which included physician-to-subject instruction and a direct-to-subject education method.
After the unmedicated period, treatment was initiated with vardenafil 10 mg tablets for 4 weeks. This will be followed by a flexible dose titration period of 4 weeks during which subjects may maintain the previous dosage regimen or will step up to 20 mg of vardenafil or will step down to 5 mg vardenafil. There is a final 4 week treatment period where the previous dosage regimen is either maintained, increased or decreased by one step according to the three applicable dosage strengths of vardenafil (5, 10 or 20 mg). The highest applicable dosage regimen of 20 mg vardenafil will not be exceeded. A 24 hour follow-up phone call is required within 24 hours of the last dose of vardenafil to collect data concerning serious adverse events, if needed.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
|Condition ICMJE||Erectile Dysfunction|
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||October 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Previous or Current Medical Conditions
1. Subjects who are taking nitrates or nitric oxide donors. 2. Subjects who are taking anticoagulants, except for antiplatelet agents. 3. Subjects who are taking androgens. 4. Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.
5. Subjects who have received any investigational drug (including placebo) within 30 days of Visit 1.
6. Use of any treatment for erectile dysfunction within the 7 days of Visit 1 or during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
7. Known hypersensitivity to Vardenafil, Bay 38-9456 or any component of the investigational medication.
8. Patients with a history of unresponsiveness to other PDE V inhibitor treatments due to lack of efficacy or significant side effects leading to discontinuation of the other PDE V inhibitor.
9. Subjects who are taking alpha blockers.
|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|
|NCT Number ICMJE||NCT00664833|
|Other Study ID Numbers ICMJE||100537, ELATED|
|Has Data Monitoring Committee||No|
|Responsible Party||Medical Affairs Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.|
|Study Sponsor ICMJE||Bayer|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Bayer|
|Verification Date||June 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP