CCH for Peyronie's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
Is Collagenase Clostridium Histolyticum (CCH) safe for humans?
How is the drug Collagenase Clostridium Histolyticum unique for treating Peyronie's Disease?
Collagenase Clostridium Histolyticum (CCH) is unique because it is the only FDA-approved nonsurgical treatment for Peyronie's Disease, offering a minimally invasive option that can reduce the need for surgery. It works by breaking down collagen, which is a key component of the scar tissue causing the condition.26789
What data supports the effectiveness of the drug Collagenase Clostridium Histolyticum (CCH) for treating Peyronie's Disease?
Who Is on the Research Team?
Thomas A Masterson, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
Men with Peyronie's Disease who have a significant bend in their penis (30° to <90°) and have had previous PRP treatments without surgery. They should be stable as judged by the doctor, able to consent, follow study procedures, and not planning any interfering medical procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intralesional collagenase clostridium histolyticum (CCH) injections following prior PRP treatment. There are 8 total treatments, with 2 injections per cycle, 24-72 hours apart, followed by a 6-week break, for a maximum of 4 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in erectile function and Peyronie's Disease symptoms.
What Are the Treatments Tested in This Trial?
Interventions
- Collagenase Clostridium Histolyticum (CCH)
Collagenase Clostridium Histolyticum (CCH) is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Endo Pharmaceuticals
Industry Sponsor
Matthew Davis
Endo Pharmaceuticals
Chief Medical Officer since 2016
MD
Scott Hirsch
Endo Pharmaceuticals
Chief Executive Officer
BA in Economics from Princeton University