N/A
Completed N=20
MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction
Erectile Dysfunction Following Radical Prostatectomy
Source: ClinicalTrials.gov NCT05673005 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Whether the Erectile Function Domain of the International Index of Erectile Function Mean Change From Baseline Met or Exceeded the Minimally Clinically Important Difference (MCID) of 4 — 0.8 IIEF-EF difference (units on scale)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whether the Erectile Function Domain of the International Index of Erectile Function Mean Change From Baseline Met or Exceeded the Minimally Clinically Important Difference (MCID) of 4 |
0.8 | — |
| SECONDARY Efficacy of MED3000 Topical Gel (Self-Esteem and Relationship Questionnaire) |
1.5 | — |
| SECONDARY Change From Baseline in All Domains of the IIEF. |
0.4 | — |
| SECONDARY Adverse Events of MED3000 Topical Gel |
— | — |
Eligibility Criteria
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 =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 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
Data sourced from ClinicalTrials.gov (NCT05673005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.