Actively Recruiting
Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
Led by Charitable Union for the Research and Education of Peyronie's Disease · Updated on 2025-02-13
40
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
Sponsors
C
Charitable Union for the Research and Education of Peyronie's Disease
Lead Sponsor
E
Endo Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Our team has previously demonstrated efficacy in performing a novel collagenase Clostridium histolyticum (CCH) injection protocol in men who previously failed to achieve a response to an initial 4 series of CCH. The objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series, followed by up to 2 additional salvage series to determine safety and efficacy compared to historical data. Participants will receive up to 4 series of CCH injections using our previously published protocol, with mild in-office modeling. CCH injections are given on back-to back days, after which they are counseled to utilize Restorex and sildenafil daily, as instructed. Patients will undergo mild in-office modeling on day 2. The sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patient's treatment.
CONDITIONS
Official Title
Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men with Peyronie's Disease
- Older than 18 years old
- Penile curvature of 30 degrees or more
- Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors
- Presence of a palpable plaque consistent with Peyronie's Disease
- Partners willing to complete a questionnaire
You will not qualify if you...
- Prior surgical treatment on the penis other than circumcision
- Prior treatment with collagenase Clostridium histolyticum injections
- Any contraindications to collagenase Clostridium histolyticum as determined by the study investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Male Fertility and Peyronie's Clinic
Orem, Utah, United States, 84057
Actively Recruiting
Research Team
L
Landon Trost, MD
CONTACT
H
Holli Burgon
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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