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New gel may help men with ED after prostate surgery

NCT ID NCT05673005

Symptom relief Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a topical gel called MED3000 for men with erectile dysfunction that persisted 1.5 to 4 years after prostate cancer surgery. Twenty men who had nerve-sparing prostatectomy used the gel on demand. The goal was to see if it improved erectile function enough to make a meaningful difference in their daily lives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Apr 2023

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

erectile dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction following radical prostatectomy

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.