MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction

Inclusion Criteria: * Men who underwent robotic bilateral nerve-sparing radical prostatectomy between 18 and 36 months prior to study commencement * Subjects are 18-48 months status-post radical prostatectomy * Subjects have any degree of erectile dysfunction based on IIEF questionnaire * Age 40 - 70 at study commencement * Diagnosed with low/intermediate-risk prostate cancer: * PSA \< 20 ng/ml * Gleason score =\< 8 * Prostate Cancer stage =\< T3a * Normal pre-radical prostatectomy erectile function (IIEF \>=26) or equivalent response on EPIC * Baseline erectile dysfunction at time of screening (despite use of erectogenic aids of any kind) and enrolment following washout (IIEF-ED domain \<=25) * Sexually active, in a stable heterosexual relationship for at least 6 months prior to screening * Able to understand and complete patient questionnaires * Serum prostate specific antigen (PSA) undetectable (no evidence of disease recurrence) * Able to consent to participate * Documented written informed consent from both patient and his female partner Exclusion Criteria: * Anatomical abnormalities in the genitalia or pelvic region such as severe phimosis * Post-Radical Prostatectomy complications that could impact safety or effectiveness of medical therapy for erectile function (treatment for pelvic hematoma, urinary or intestinal fistula, unresolved anastomotic leak) * Tumor upstaging beyond T3a * Incomplete / sub-total nerve sparing on either side * Previous or scheduled t…