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Sponsors and Collaborators: |
Bayer ONYX Pharmaceuticals |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00657644 |
To find out more information on how effective and safe vardenafil is at treating impotence in men living in Russia.
Condition | Intervention | Phase |
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Erectile Dysfunction |
Drug: Levitra (Vardenafil, BAY38-9456) |
Phase III |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Safety/Efficacy Study, Single Group Assignment, Treatment, Uncontrolled |
Official Title: | Open-Label Multi-Centre Non Randomised Study of Efficacy and Safety of Vardenafil (BAY 38-9456; SB-782528) Administered in Flexible-Dose Regimen in Males With Erectile Dysfunction of Broad Aetiology. |
Enrollment: | 120 |
Study Start Date: | August 2003 |
Study Completion Date: | March 2004 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Levitra (Vardenafil, BAY38-9456)
4 weeks treatment with 10 mg vardenafil followed by a flexible titration phase for 8 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Concomitant Medication
1. Subjects who have a serum total testosterone level greater than 25% below the lower limit of normal according to the range of the testing laboratory. 2. Subjects with a serum creatinine >3.0 mg/dl. 3. Elevation of AST and/or ALT >3X the ULN. 4. Diabetic subjects with an HbA1c >12%.
Russian Federation | |
Moscow, Russian Federation, 105425 | |
Moscow, Russian Federation, 117198 | |
Moscow, Russian Federation, 127206 | |
Moscow, Russian Federation, 123367 | |
Moscow, Russian Federation, 117837 | |
St Petersburg, Russian Federation, 198013 | |
Moscow, Russian Federation, 125101 | |
Moscow, Russian Federation, 117997 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Therapeutic Area Head ( Bayer HealthCare AG ) |
Study ID Numbers: | 11182 |
Study First Received: | April 8, 2008 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00657644 History of Changes |
Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation |
Erectile Dysfunction |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Vardenafil Sexual Dysfunction, Physiological |
Mental Disorders Genital Diseases, Male Erectile Dysfunction |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Vardenafil Sexual Dysfunction, Physiological Molecular Mechanisms of Pharmacological Action Mental Disorders |
Enzyme Inhibitors Genital Diseases, Male Sexual and Gender Disorders Erectile Dysfunction Pharmacologic Actions |