Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)

Completed · Phase 3 · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

This study is being conducted to compare the safety and efficacy of 2 doses of avanafil to placebo in diabetic men with mild to severe erectile dysfunction.

Key facts

Study ID

NCT00809471

Run by

VIVUS LLC

People needed

390

Starts

2008-12-01

Expected to finish

2010-02-01

Last updated by the study team

2012-08-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male subjects, age ≥ 18 years;
• 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.

You may not qualify if…

• Allergy or hypersensitivity to PDE5 inhibitors;
• 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;

Where it is running

• 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

Full record on ClinicalTrials.gov

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