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Enzyme
CCH for Peyronie's Disease
Phase 4
Recruiting
Led By Thomas Masterson, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights
Study Summary
This trial studies how safe and effective it is to add CCH to PRP injections for treating Peyronie's Disease.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing the safety and effects of injecting CCH into penile plaque in men who've previously received PRP injections for Peyronie's Disease. The goal is to see if this treatment can help correct penile curvature after initial PRP therapy.See study design
What are the potential side effects?
Possible side effects from CCH may include pain at the injection site, swelling, bruising, bleeding or other reactions. Since it involves an injection directly into the penis plaque, there might also be specific risks related to that procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Treatment Related Adverse Events
Percent change of penile curvature in degrees.
Secondary outcome measures
Change in Peyronie's Disease Questionnaire (PDQ) sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
Changes in International Index of Erectile Function - Erectile Function (IIEF-EF) scores
Trial Design
1Treatment groups
Experimental Treatment
Group I: Collagenase Clostridium Histolyticum (CCH) GroupExperimental Treatment1 Intervention
There will be 8 total treatments. These will follow the manufacturer protocol of 2 injections 24-72 hours apart (one cycle), followed by a 6-week break. This will total a maximum of 4 cycles.
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Who is running the clinical trial?
Endo PharmaceuticalsIndustry Sponsor
133 Previous Clinical Trials
33,133 Total Patients Enrolled
University of MiamiLead Sponsor
902 Previous Clinical Trials
410,054 Total Patients Enrolled
2 Trials studying Genital Diseases
280 Patients Enrolled for Genital Diseases
Thomas Masterson, MDPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an hour-glass shaped deformity.I am not willing to participate in the trial.I can feel a lump in my penis.I have Peyronie's disease with a plaque on the front side of my penis.My penile curvature is between 30° and 90°.My Parkinson's disease is stable according to my doctor.I have a planned medical procedure that will conflict with my PRP injection therapy.I've had platelet rich plasma treatment for penile curvature within the last 18 months and want more treatment.I haven't had CCH injection therapy for PD in the last 6 months.I can feel a lump in my penis.My Parkinson's disease is stable, as confirmed by my doctor.I have had penile surgery, excluding circumcision and condyloma removal.
Research Study Groups:
This trial has the following groups:- Group 1: Collagenase Clostridium Histolyticum (CCH) Group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the associated risks of utilizing Collagenase Clostridium Histolyticum (CCH) Group as a treatment?
"The safety of Collagenase Clostridium Histolyticum (CCH) Group was rated a 3, as it is currently approved and in its fourth phase trial."
Answered by AI
Does the current clinical study accept individuals under 35 years of age?
"Patients aged 18 to 75 are eligible for this trial. For those younger than 18 and seniors over 65, there are two trials and fifteen trials respectively available."
Answered by AI
Are there opportunities for people to participate in this experiment at the moment?
"According to clinicaltrials.gov, enrollment for this trial is now closed. Initially posted on May 1st 2023 and last updated March 8th of the same year, no more patients are being accepted at present. Nonetheless, there are 16 other medical studies that remain open for recruitment currently."
Answered by AI
To whom does eligibility for this trial apply?
"To qualify for admission to this clinical trial, applicants must have been diagnosed with peyronie's disease and be between 18-75 years old. A total of 22 participants will be included in the study."
Answered by AI
Who else is applying?
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
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