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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00652262 |
BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not sufficiently effective
Condition | Intervention | Phase |
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Erectile Dysfunction Sexual Dysfunction Spinal Cord Injury |
Drug: Levitra (Vardenafil, BAY38-9456) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open, Multi-Centre, Flexible Dose Uptitration Study to Investigate the Efficacy and Safety of Vardenafil 10 mg and 20 mg in Males With Spinal Cord Injury Suffering From Erectile Dysfunction |
Enrollment: | 30 |
Study Start Date: | March 2004 |
Study Completion Date: | November 2004 |
Arms | Assigned Interventions |
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Arm 1: Experimental
n/a
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Drug: Levitra (Vardenafil, BAY38-9456)
Patients received BAY 38-9456 10 mg for the first 4 weeks of the treatment period, and then went on to receive 10 mg or 20 mg for the following 8 weeks.
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Ages Eligible for Study: | 20 Years to 64 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, Aichi | |
Nagoya, Aichi, Japan, 455-8530 | |
Japan, Fukuoka | |
Iizuka, Fukuoka, Japan, 820-0053 | |
Japan, Oita | |
Beppu, Oita, Japan, 874-0937 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | ( Bayer Schering Pharma AG, Therapeutic Area Head ) |
Study ID Numbers: | 100608 |
Study First Received: | April 1, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00652262 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency; United States: Food and Drug Administration |
Vardenafil PDE5 inhibitor Erectile dysfunction Spinal cord injury |
Sexual Dysfunctions, Psychological Spinal Cord Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System Genital Diseases, Male |
Spinal Cord Injuries Sexual Dysfunction, Physiological Vardenafil Spinal Injuries Mental Disorders Erectile Dysfunction |
Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Nervous System Diseases |
Enzyme Inhibitors Sexual and Gender Disorders Pharmacologic Actions |