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 4 years following radical prostatectomy surgery.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction Following Radical Prostatectomy
• Intervention / Treatment: Device: MED3000 topical gel

Detailed Description

MED3000 is a topical gel that has been developed to treat patients with erectile dysfunction. The investigators postulate that on demand treatment with MED3000 can improve on-demand erectile function among men status-post radical prostatectomy, allowing for some endogenous cavernosal nerve function recovery for 1.5 to 4 years post-surgery among men with normal baseline pre-surgical erectile function.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MED3000 topical gel treatment; All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits.	Device: MED3000 topical gel; Topical gel that has been shown to improve erectile dysfunction when used as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	To investigate the effect of MED3000 topical gel for treatment of erectile dysfunction after nerve sparing prostatectomy (based on Erectile Function domain of the International Index of Erectile Function) (units on a scale) and whether it met MCID criteria of change of mean 4 [IIEF EF minimum score is 0, maximum score is 75, with higher scores representing improved erectile function); units on a scale	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of MED3000 Topical Gel (Self-Esteem and Relationship Questionnaire)	The efficacy of MED3000 in patients at weeks 4, 8 and 12 using: The change from baseline in Self-Esteem and Relationship (SEAR) questionnaire for men (units on a scale) [SEAR minimum score is 0, maximum score is 70, with higher scores representing improved outcomes); units on a scale	12 weeks
Adverse Events of MED3000 Topical Gel	Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000.	12 weeks
Change From Baseline in All Domains of the IIEF.	The efficacy of MED3000 in patients at weeks 4, 8 and 12 (units on a scale). To investigate the effect of MED3000 topical gel for treatment of erectile dysfunction after nerve sparing prostatectomy (based on Erectile Function domain of the International Index of Erectile Function) (units on a scale) and whether it changed over time [IIEF EF minimum score is 0, maximum score is 75, with higher scores representing improved erectile function]; units on a scale	12 weeks

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Martin Kathrins, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): July 24, 2024
• Study Completion (Actual): August 9, 2024

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: 2021P002976

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No