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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00664833 |
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.
Condition | Intervention | Phase |
---|---|---|
Erectile Dysfunction |
Behavioral: Levitra (Vardenafil, BAY38-9456) Other: No Education |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Enrollment: | 1380 |
Study Start Date: | May 2004 |
Study Completion Date: | October 2005 |
Arms | Assigned Interventions |
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Arm 2: Experimental
n/a
|
Behavioral: Levitra (Vardenafil, BAY38-9456)
The Subject received the educational intervention
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Arm 4: No Intervention
n/a
|
Other: No Education
No education provided to either the Primary Care Physician (PCP) or the subject.
|
Arm 3: Experimental
n/a
|
Behavioral: Levitra (Vardenafil, BAY38-9456)
Both the Primary Care Physician (PCP) and the subject received the educational intervention
|
Arm 1: Experimental
n/a
|
Behavioral: Levitra (Vardenafil, BAY38-9456)
The Primary Care Physician (PCP) received the educational intervention
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Previous or Current Medical Conditions:
Concomitant Medications:
Other Exclusions:
Responsible Party: | ( Bayer HealthCare Pharmaceuticals Inc., Therapeutic Area Head ) |
Study ID Numbers: | 100537, ELATED |
Study First Received: | April 18, 2008 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00664833 |
Health Authority: | Canada: Health Canada; United States: Institutional Review Board |
Erectile dysfunction Phosphodiesterase Type 5 Inhibitors Patient education Impotence Vardenafil |
Sexual Dysfunctions, Psychological Vardenafil Sexual Dysfunction, Physiological |
Mental Disorders Genital Diseases, Male Erectile Dysfunction |
Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Sexual and Gender Disorders Pharmacologic Actions |