Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Placebo; Avanafil; Avanafil
Intervention description: One dose 30 minutes prior to initiation of sexual activity; One dose 30 minutes prior to initiation of sexual activity; One dose 30 minutes prior to initiation of sexual activity
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 298.0
Sex: Male
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Erectile Dysfunction; E.D.

Summary:

      The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil
      in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing
      radical prostatectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males ≥ 18 years and ≤ 70 years;

          -  Have a history of erectile dysfunction of at least 6 months duration following
             bilateral nerve-sparing retropubic radical prostatectomy;

          -  Have a PSA level consistent with the absence of prostate cancer;

          -  Have a history of sexual potency prior to radical prostatectomy without requiring
             medical therapy;

          -  Be in a monogamous, heterosexual relationship with their current partner for at least
             3 months;

          -  Provide written informed consent;

          -  Agree to make at least 4 attempts at intercourse per month;

          -  Agree not to use any other treatments for erectile dysfunction;

          -  Be willing and able to comply with all study requirements (including scheduled study
             visits, treatment plans, laboratory tests and other study procedures).

        Exclusion Criteria

          -  Allergy or hypersensitivity to PDE5 inhibitors or any of the components of these drug
             products;

          -  History of dose-limiting AEs during prior treatment with a PDE5 inhibitor or
             discontinued use of a PDE5 inhibitor due to lack of efficacy at the highest tolerated
             dose;

          -  Concomitant use of one or more of the following medications:

               -  Any nitrate, trazodone, itraconazole, ketoconazole, erythromycin, or cimetidine;

               -  Other prescription or OTC drugs that are known to interfere with metabolism by
                  the CYP 3A4 enzyme;

               -  If receiving hormone replacement therapy (including thyroid supplementation),
                  dose that has not been stable for at least 3 months;

               -  If treated with an alpha blocker, dose that has not been stable for at least 14
                  days;

          -  Erectile dysfunction as a consequence of advanced neurologic disease, spinal cord
             injury, or diabetes;

          -  History of severe erectile dysfunction requiring medical therapy prior to bilateral
             nerve-sparing radical prostatectomy;

          -  History of previous pelvic surgery, brachytherapy, or cryotherapy of the prostate;

          -  Sexual partner who is under 18 years of age, pregnant, intends to become pregnant
             during the course of the study, is breastfeeding, has dyspareunia or other gynecologic
             conditions or other major medical conditions that would interfere with sexual activity
             or would have difficulty complying with study requirements;

          -  Uncontrolled hypertension;

          -  Hypotension;

          -  Orthostatic hypotension;

          -  Myocardial infarction, stroke, life-threatening arrhythmia or coronary
             revascularization within the past 6 months;

          -  Unstable angina, angina with sexual intercourse, or congestive heart failure > NYHA
             Class II;

          -  History or ECG evidence of any high-risk arrhythmia or clinically significant ECG;

          -  Hypertrophic, obstructive, or other clinically significant cardiomyopathy, moderate or
             severe cardiac valvular disease;

          -  Type 1 or type 2 diabetes, history of use of any antidiabetic medication;

          -  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;

          -  Condition(s) predisposing to priapism, such as sickle cell disease , multiple myeloma,
             or leukemia;

          -  Any malignancy other than carcinoma of the prostate (except basal cell carcinoma or
             squamous cell carcinoma of the skin);

          -  Prior use of, or likely to require radiotherapy, chemotherapy, androgen deprivation
             therapy, cryotherapy, non-nerve-sparing surgery, and/or bladder or penile surgery
             during the study;

          -  Evidence of significant hepatic impairment;

          -  On dialysis, or history of renal transplantation;

          -  Untreated hypogonadism or low serum total testosterone;

          -  Abnormal laboratory value(s) judged to be clinically significant by the investigator;

          -  Positive STD screen (syphilis, gonorrhea, or chlamydia);

          -  Positive for HIV, HCV Ab, or HBsAg at screening;

          -  History or current drug, alcohol, or substance abuse;

          -  Positive urine drug screen;

          -  Positive breath alcohol test;

          -  Retinitis pigmentosa or nonarteritic anterior ischemic optic neuropathy;

          -  Use of any treatment or device for treatment of erectile dysfunction;

          -  Use of any other investigational medication or device for any indication within 30
             days prior to enrollment or at any time during this study;

          -  Previous participation in any other investigational study of avanafil;

          -  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;

          -  Involvement in the planning and conduct of the study on the part of subject or
             partner;

          -  Evidence of any clinically significant medical, psychiatric, social or other condition
             by history, physical examination or laboratory studies that, in the opinion of the
             investigator, would contraindicate the administration of study medications, affect
             compliance, interfere with study evaluations, limit study participation,
             contraindicate sexual activity or confound the interpretation of study results.