Actively Recruiting
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
Led by University of Miami · Updated on 2026-03-23
22
Participants Needed
2
Research Sites
171 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
E
Endo Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be able to provide written informed consent
- Have a diagnosis of Peyronie's Disease with evidence of stable disease as determined by the investigator
- Have a palpable penile plaque
- Have a penile curvature deformity greater than 30 degrees and less than 90 degrees
- Agree to comply with all study related tests and procedures
- Have received prior intralesional platelet rich plasma treatment within the past 18 months and desire secondary treatment of penile curvature
You will not qualify if you...
- Previous penile surgery of any kind (except circumcision and condyloma removal), including penile lengthening, penile cancer surgery, penile plication, grafting, or penile prosthesis
- Previous intralesional injection therapy with collagenase clostridium histolyticum for Peyronie's Disease within six months (failed therapy greater than six months ago may be included)
- Previous history of priapism or penile fracture
- Peyronie's Disease characterized by a ventral plaque
- Severe erectile dysfunction with an IIEF score of 12 or less
- Presence of hour-glass deformity
- Unwilling to participate
- Medically unfit for sexual intercourse as determined by the principal investigator
- Scheduled to undergo an elective medical procedure during the study that would interfere with autologous PRP injection therapy
- Serious comorbid illness, condition, or behavior that may compromise safety, compliance, or study completion as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Miami - Desai Sethi Urology Institute
Miami, Florida, United States, 33136
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
T
Thomas Masterson, MD
CONTACT
M
Manuel Molina, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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