Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)
NCT ID: NCT00809471
Last Updated: 2012-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
390 participants
INTERVENTIONAL
2008-12-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo
placebo
30 minutes orally prior to initiation of sexual activity
avanafil 100 mg
avanafil
30 minutes orally prior to initiation of sexual activity
avanafil 200 mg
avanafil
30 minutes orally prior to initiation of sexual activity
Interventions
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placebo
30 minutes orally prior to initiation of sexual activity
avanafil
30 minutes orally prior to initiation of sexual activity
avanafil
30 minutes orally prior to initiation of sexual activity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Minimum 6 month history of mild to severe erectile dysfunction;
* Have documented diabetes (type 1 or type 2);
* Subject is in a monogamous, heterosexual relationship for at least 3 months;
* Subject agrees to make at least 4 attempts at intercourse per month;
* Subject is willing and able to provide informed consent.
Exclusion Criteria
* History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;
* Current or expected use of organic nitrates at any time during the study;
* Previous or current antiandrogen therapy;
* Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;
* Androgen replacement therapy that has not been stable for at least 3 month;
* Initiation or change in dose of any alpha-blocker within 14 days prior to randomization;
* ED as a result of spinal cord injury or radical prostatectomy;
* Untreated hypogonadism or low serum total testosterone
* History of or predisposition to priapism;
* Any penile implant;
* Elevated PSA, other evidence of prostate cancer, or previous radical prostatectomy;
* History of any malignancy (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision);
* Uncontrolled diabetes;
* Uncontrolled hypertension;
* Hypotension;
* Orthostatic hypotension;
* Significant cardiovascular disease;
* Abnormal ECG;
* Hepatic or renal impairment;
* Positive STD screen;
* Clinically evident penile lesions, abrasions, or anatomical deformities;
* Urinary tract or bladder infection;
* Use of any treatment for erectile dysfunction other than study drug at any time during the study;
* Participation in another investigational study within 30 days of screening or at any time during this study;
* Previous participation in any other investigational study of avanafil;
* History or current drug, alcohol, or substance abuse;
* Any history of bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity or antidepressant use that has not been stable for at least 3 months;
* Partners who are \< 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems or major medical conditions that would limit participation in sexual intercourse;
* Evidence of any other condition by history, physical examination, or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results.
18 Years
MALE
No
Sponsors
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VIVUS LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Irwin Goldstein, MD
Role: PRINCIPAL_INVESTIGATOR
San Diego Sexual Medicine
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Homewood, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
San Diego, California, United States
Research Site
Waterbury, Connecticut, United States
Research Site
Clearwater, Florida, United States
Research Site
Clearwater, Florida, United States
Research Site
Coral Gables, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Jupiter, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Wichita, Kansas, United States
Research Site
Madisonville, Kentucky, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Kansas City, Missouri, United States
Research Site
Lawrenceville, New Jersey, United States
Research Site
Albany, New York, United States
Research Site
Cary, North Carolina, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Harrisburg, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Salisbury, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Beachwood, Ohio, United States
Research Site
Bala-Cynwyd, Pennsylvania, United States
Research Site
Lancaster, Pennsylvania, United States
Research Site
El Paso, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Spring, Texas, United States
Countries
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References
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Goldstein I, Jones LA, Belkoff LH, Karlin GS, Bowden CH, Peterson CA, Trask BA, Day WW. Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus. Mayo Clin Proc. 2012 Sep;87(9):843-52. doi: 10.1016/j.mayocp.2012.06.016. Epub 2012 Aug 1.
Other Identifiers
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TA-302
Identifier Type: -
Identifier Source: org_study_id