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

The investigators are doing this research to evaluate the efficacy and safety of topical MED3000 therapy in men with persistent erectile dysfunction 1.5 to 3 years following radical prostatectomy surgery.

Inclusion Criteria:Men who underwent robotic bilateral nerve-sparing radical prostatectomy between 18 and 36 months prior to study commencementSubjects are 18-36 months status-post radical prostatectomySubjects have any degree of erectile dysfunction based on IIEF questionnaireAge 40 - 70 at study commencementDiagnosed with low/intermediate-risk prostate cancer:PSA < 20 ng/mlGleason score =< 8Prostate Cancer stage =< T2bNormal pre-radical prostatectomy erectile function (IIEF >=26)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 screeningAble to understand and complete patient questionnairesSerum prostate specific antigen (PSA) undetectable (no evidence of disease recurrence)Able to consent to participateDocumented written informed consent from both patient and his female partnerExclusion Criteria:Anatomical abnormalities in the genitalia or pelvic region such as severe phimosisPost-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)Incomplete tumor removal (positive surgical margin)Tumor upstaging beyond T2bIncomplete / sub-total nerve sparing on either sidePrevious or scheduled treatment with pelvic salvage radiotherapy and/or androgen deprivation therapyPrior receipt of androgen deprivation therapyAny other condition that would prevent the patient from completing the study, as judged by the Principal Investigator