| Protocol Number: TA-303 10/2009 - Present | |
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Eligibility Criteria for participation: · Be adult males ≥ 18 years and ≤ 70 years of age at the time of Screening · Have a history of erectile dysfunction of at least 6 months duration following bilateral nerve-sparing retropubic radical prostatectomy, as evidenced by an inability to penetrate their partner on at least 50% of attempts at sexual intercourse without the use of medical therapy · Have undergone a bilateral nerve-sparing retropubic radical prostatectomy for localized carcinoma of the prostate at least 6 months prior to screening · Staging of prostate carcinoma ≤ pT2 and Gleason score ≤ 7 (4 + 3) · Have a prostate specific antigen (PSA) level at screening that is consistent with the absence of residual prostate cancer · Have a history of sexual potency prior to radical prostatectomy that did not require routine medical therapy to achieve or maintain an erection · Be in a monogamous, heterosexual relationship with their current partner for at least 3 months · Agree to make at least 4 attempts at intercourse per month · No erectile dysfunction as a consequence of advanced neurologic disease, spinal cord injury, or diabetes · No known allergy or hypersensitivity to avanafil, sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®) or any of the components of these drug products · No history of severe erectile dysfunction requiring routine medical therapy prior to bilateral nerve-sparing radical prostatectomy · No uncontrolled hypertension as evidenced by systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg at screening · No hypotension as evidenced by systolic blood pressure < 90 mmHg or diastolic blood pressure < 50 mmHg at screening · No myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months · No clinically evident penile lesions, abrasions, anatomical deformities such as penile fibrosis, Peyronie’s disease, penile implants, urinary tract or bladder infection, or sexually transmissible disease that the investigator deems to be clinically significant No condition(s) predisposing to priapism, such as sickle cell disease, multiple myeloma, or leukemia · No history of any malignancy other than carcinoma of the prostate (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision)
Duration of Study
Clinical Research Coordinators: |
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