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

Completed · Not applicable

Conditions studied: Erectile Dysfunction Following Radical Prostatectomy

In brief

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 4 years following radical prostatectomy surgery.

Key facts

Study ID

NCT05673005

Run by

Brigham and Women's Hospital

People needed

20

Starts

2023-04-01

Expected to finish

2024-08-09

Last updated by the study team

2026-03-11

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 treatment with pelvic salvage radiotherapy and/or androgen deprivation therapy
• Prior receipt of androgen deprivation therapy
• Any other condition that would prevent the patient from completing the study, as judged by the Principal Investigator

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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