Can a new injection strategy help men with Peyronie's disease who failed standard treatment?
NCT ID NCT05108558
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
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Sep 2021
- Finished
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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
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18 years and older
- Sex
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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 Hide 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.
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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