MedDataX Logo

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

NCT ID: NCT05673005

Last Updated: 2025-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-08-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erectile Dysfunction Following Radical Prostatectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Medical device (MED3000)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MED3000 topical gel treatment

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

Group Type EXPERIMENTAL

MED3000 topical gel

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MED3000 topical gel

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Martin Kathrins, M.D.

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Kathrins, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021P002976

Identifier Type: -

Identifier Source: org_study_id