Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction
NCT00657033 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 229
Last updated 2013-10-14
Summary
Study to investigate the efficacy and safety of vardenafil flexible dose versus placebo in males with erectile dysfunction, and their female partners' sexual quality of life.
Conditions
Interventions
- DRUG
-
Levitra (Vardenafil, BAY38-9456)
BAY 38-9456 (Vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.
- DRUG
-
Identical placebo tablets will be matched for each vardenafil dosage and will be indistinguishable from active treatment
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-10-31
- Completion
- 2004-08-31
Countries
- United States
- Canada
Study Locations
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