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 18and 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 equivalentresponse on EPIC

• Baseline erectile dysfunction at time of screening (despite use of erectogenic aidsof any kind) and enrolment following washout (IIEF-ED domain <=25)

• Sexually active, in a stable heterosexual relationship for at least 6 months priorto screening

• Able to understand and complete patient questionnaires

• Serum prostate specific antigen (PSA) undetectable (no evidence of diseaserecurrence)

• 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 effectivenessof medical 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