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New urethral gel could help men with erectile dysfunction

NCT ID NCT07601646

Symptom relief Sponsor: Ryan Flannigan, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new gel called ST-04 that is placed inside the urethra (the tube in the penis) to help men with erectile dysfunction (ED) who haven't had success with standard pills. The gel contains a medicine that widens blood vessels to produce an erection. About 83 men will try up to 3 different doses over 12 weeks, sometimes combined with sildenafil (Viagra), to see if it improves their ability to get and keep an erection.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 83 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

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

21 to 75 years

Sex

Male participants only

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: * Have had a confirmed clinical diagnosis of ED for more than three months based upon IIEF * Have failed PDE5 inhibitor therapy (inability to achieve an erection with adequate rigidity to allow penetrative sex) * Ability to take oral medication (sildenafil) and be willing to adhere to the study intervention regimen * Engaged in heterosexual relationship with partner for a minimum of 6 months Exclusion Criteria: * History of unstable medical or psychiatric condition that, in the opinion of the principal investigator, could impact the patient's ability to complete the study investigations or protocol. * Spinal cord injury, or penile anatomical abnormalities * Cardiovascular conditions that prevent sexual activity (NYHA Class II or higher, any angina, or uncontrolled CHF or severe coronary artery disease) * History of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to enrollment into the study * Use of anti-androgens, or oral or injectable androgens * Documented hypotension or known orthostatic hypotension * Use of oral, topical or sublingual nitrates within 3 months prior to enrollment into the study * Hepatic (Child-Pugh Class C) or renal failure (eGFR \< 30) * Inadequate response to intracavernosal injection therapy previously * Peyronie's disease or Meatal stenosis

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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 (ED) Erectile dysfunctions Erectile function

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vancouver Prostate Centre

    RECRUITING

    Vancouver, British Columbia, V5Z1M9, Canada

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