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 responseon EPIC
• Baseline erectile dysfunction at time of screening (despite use of erectogenic aids ofany kind) and enrolment following washout (IIEF-ED domain <=25)
• Sexually active, in a stable heterosexual relationship for at least 6 months prior toscreening
• 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 ofmedical therapy for erectile function (treatment for pelvic hematoma, urinary orintestinal fistula, unresolved anastomotic leak)
• Tumor upstaging beyond T3a
• Incomplete / sub-total nerve sparing on either side
• Previous or scheduled treatment with pelvic salvage radiotherapy and/or androgendeprivation therapy
• Prior receipt of androgen deprivation therapy
• Any other condition that would prevent the patient from completing the study, asjudged by the Principal Investigator