Can a new injection strategy help men with Peyronie's disease who failed standard treatment?

NCT ID NCT05108558

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial is testing whether a new way of giving collagenase injections can help men with Peyronie's disease who have not improved with standard treatment. Peyronie's disease causes a curved, painful erection due to scar tissue. The study will compare men who receive up to 8 injections of the new protocol against a control group that waits 6 months before receiving the same injections. The goal is to see if the new approach reduces penile curvature and improves symptoms like pain and bother.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Collagenase Clostridium Histolyticum (CCH) injections
What this could lead to
If successful, this could offer a new treatment option for men with Peyronie's disease who have not benefited from standard CCH injections, potentially reducing penile curvature and improving symptoms.
What could go wrong
This is a small, early-stage trial (Phase 4) with only 40 participants. The new protocol may not work better than the standard approach, and there are risks of injection-related side effects. Results may not apply to all patients.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

40 people

The number who actually took part.

Started

Sep 2021

Finished

Jun 2026

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

18 years and older

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: * Men with Peyronie's Disease * \>18 years old * Curvature ≥30 degrees * Previously completed 6-8 CCH injections * Prior minimal (\<20% and/or \<10 degrees) responsiveness to CCH administration * Prior CCH injections must have been performed without use of a Restorex traction device and used the IMPRESS protocol * Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors * The patient exhibits a palpable plaque consistent with Peyronie's Disease Exclusion Criteria: * Prior surgical treatment on the penis (other than circumcision) * Any contraindications to CCH - as determined by the PI * Inability to complete 8 additional CCH injections * Severe plaque calcification (i.e. \>1 cm shadowing)

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Conditions

The condition(s) this trial relates to.

Penile Induration Peyronie disease

As listed by the trial registrant

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

Contacts and locations

Locations

  • The Male Fertility and Peyronie's Clinic

    Orem, Utah, 84057, United States

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