Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Placebo; Avanafil 100 mg; Avanafil 200 mg
Intervention description: One dose 15 minutes before attempting intercourse; One dose 15 minutes before attempting intercourse; One dose 15 minutes before attempting intercourse
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 440.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ED

Summary:

      The objectives of this study are to examine the therapeutic effects of two doses of avanafil
      after dosing in men with erectile dysfunction
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males ≥ 18 years of age;

          -  Minimum 6 months of erectile dysfunction;

          -  In a monogamous, heterosexual relationship for at least 3 months;

          -  Agree to make at least 4 attempts at intercourse per month;

          -  Provide written informed consent;

          -  Agree not to use any other ED treatments for erectile dysfunction;

          -  Willing and able to comply with all study requirements.

        Exclusion Criteria:

          -  Allergy or hypersensitivity to PDE5 inhibitors;

          -  History of dose-limiting AEs with a PDE5 inhibitor or discontinued use of a PDE5
             inhibitor;

          -  Concomitant use of one or more of the following medications:

               -  Other prescription or OTC drugs known to interfere with metabolism by the CYP 3A4
                  enzyme;

               -  Dose of an alpha blocker that has not been stable for at least 14 days;

               -  Any nitrate;

          -  ED as a consequence of advanced neurologic disease, spinal cord injury,or radical
             prostatectomy;

          -  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;

          -  Poorly controlled type 1 or type 2 diabetes;

          -  Evidence of prostate cancer or previous radical prostatectomy;

          -  Untreated hypogonadism or total testosterone levels outside normal reference range;

          -  Abnormal laboratory value(s) judged to be clinically significant by the investigator;

          -  Positive urine drug screen;

          -  History of retinitis pigmentosa, nonarteritic anterior ischemic optic neuropathy or
             glaucoma;

          -  Previous participation in any other study with avanafil;

          -  Use of any other investigational medication or device for any indication within 30
             days prior to enrollment or at any time during this study;

          -  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.