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

NCT05673005 | Completed Results FDA Device

• 1 other identifier: 2021P002976
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Efficacy of MED3000 Topical Gel (Self-Esteem and Relationship Questionnaire)

  12 weeks

• Change From Baseline in All Domains of the IIEF.

  12 weeks

• Adverse Events of MED3000 Topical Gel

  12 weeks

Study Arms (1)

MED3000 topical gel treatment

EXPERIMENTAL

All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits.

Device: MED3000 topical gel

Interventions

MED3000 topical gel DEVICE

Topical gel that has been shown to improve erectile dysfunction when used as needed.

MED3000 topical gel treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Results Point of Contact

• Title: Martin Kathrins, MD
• Organization: Mass General Brigham Department of Urology

mkathrins@bwh.harvard.edu

617-732-6227

Study Officials

• Martin Kathrins, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: Medical device (MED3000)

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 5, 2023
• Study Start: April 1, 2023
• Primary Completion: July 24, 2024
• Study Completion: August 9, 2024
• Last Updated: March 11, 2026
• Results First Posted: December 30, 2025

Record last verified: 2025-11

Locations

US (1)