A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia
NCT ID: NCT00379756
Last Updated: 2017-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
395 participants
INTERVENTIONAL
2006-05-22
2007-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Levitra
10mg x 4 weeks, with option to increase to 20mg aat that time if desired
LEVITRA (vardenafil)
active comparator
placebo
placebo
placebo comparator
Interventions
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LEVITRA (vardenafil)
active comparator
placebo
placebo comparator
Eligibility Criteria
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Inclusion Criteria
* Stable heterosexual relationship for more than 6 months.
* The subject must make at least four attempts at sexual intercourse (according to the question in the subject diary: Was sexual activity initiated with the intention of intercourse?) on four separate days during the untreated baseline period. At least 50% of attempts during this period must be unsuccessful, according to the following questions from the subject diary \[at least one question should be answered "No"\]: Were you able to achieve at least some erection (some enlargement of the penis)? Were you able to insert your penis into your partner's vagina? Did your erection last long enough for you to have successful intercourse?
* Diagnosis of dyslipidemia treated with a stable dose of a statin for 6 months at Visit 1.
* IIEF-EF domain score of 25 denoting mild to severe ED at Visit 2.
* Documented, dated, written Informed Consent.
Exclusion Criteria
* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities, or substance abuse disorder that MD feels subject will not be able to complete the study.
* Low sexual desire.
* Prior prostatectomy surgery
* Severe chronic or acute liver disease, history of moderate or severe liver impairment
* Clinically significant chronic hematological disease
* Bleeding disorder or significant active peptic ulceration.
* Cardiovascular conditions that prevent sexual activity.
* History of heart attack, stroke, or life-threatening arrhythmia within the prior 6 months.
* hypotension or hypertension at rest.
* cancer within the past 5 years. Use of these medications: nitrates or nitric oxide donors, anti-androgens, oral or injectable androgens, received any investigational drug (including placebo) within 30 days of screening (Visit 1).
* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
* Subjects who are taking the following potent inhibitors of cytochrome P-450 3A4.
* Abnormal Laboratory Values:
1. serum total testosterone level \>25% below the lower limit of normal
2. serum creatinine \>3.0 mg/dl.
3. AST and/or ALT \>3x the upper limit of normal.
18 Years
64 Years
MALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Fairhope, Alabama, United States
GSK Investigational Site
Homewood, Alabama, United States
GSK Investigational Site
Huntsville, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Concord, California, United States
GSK Investigational Site
Huntington Park, California, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Modesto, California, United States
GSK Investigational Site
Newport Beach, California, United States
GSK Investigational Site
Orangevale, California, United States
GSK Investigational Site
Santa Ana, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Wheat Ridge, Colorado, United States
GSK Investigational Site
New Britain, Connecticut, United States
GSK Investigational Site
Aventura, Florida, United States
GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
Coral Gables, Florida, United States
GSK Investigational Site
Fort Myers, Florida, United States
GSK Investigational Site
North Miami, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Pembroke Pines, Florida, United States
GSK Investigational Site
Pinecrest, Florida, United States
GSK Investigational Site
Sarasota, Florida, United States
GSK Investigational Site
South Miami, Florida, United States
GSK Investigational Site
St. Petersburg, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Columbus, Georgia, United States
GSK Investigational Site
Dawsonville, Georgia, United States
GSK Investigational Site
Roswell, Georgia, United States
GSK Investigational Site
Woodstock, Georgia, United States
GSK Investigational Site
Avon, Indiana, United States
GSK Investigational Site
Evansville, Indiana, United States
GSK Investigational Site
Fort Wayne, Indiana, United States
GSK Investigational Site
Jeffersonville, Indiana, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Madisonville, Kentucky, United States
GSK Investigational Site
Shreveport, Louisiana, United States
GSK Investigational Site
Swansea, Maine, United States
GSK Investigational Site
Taunton, Massachusetts, United States
GSK Investigational Site
Kalamazoo, Michigan, United States
GSK Investigational Site
Saint Louis Park, Minnesota, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Lawrenceville, New Jersey, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
West Seneca, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Fayetteville, North Carolina, United States
GSK Investigational Site
Winston-Salem, North Carolina, United States
GSK Investigational Site
Shippensburg, Pennsylvania, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Amarillo, Texas, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Norfolk, Virginia, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Menomonee Falls, Wisconsin, United States
GSK Investigational Site
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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106718
Identifier Type: -
Identifier Source: org_study_id
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