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Novel CCH Protocol for Peyronie's Disease
Study Summary
This trial compares the effects of a new CCH administration protocol in men who haven't responded to CCH before.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have completed 6-8 injections for my condition.I have no health conditions that prevent me from receiving CCH treatment.I have had surgery on my penis, not including circumcision.I am a man with Peyronie's Disease.I cannot complete 8 more CCH injections.I can have an erection good enough for sex, with or without medication.I am older than 18 years.I received CCH injections without a Restorex device, following the IMPRESS protocol.My condition slightly improved with previous CCH treatment.I have a noticeable hard lump in my penis, indicating Peyronie's Disease.I am over 18 years old.
- Group 1: Collagenase Clostridium Histolyticum
- Group 2: Control - Crossover to CCH
- 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.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
To what degree is CCH administration hazardous for individuals?
"Our team has confidently assigned CCH a safety rating of 3, as this stage 4 trial indicates the drug is approved for medical use."
What are the hopes to be achieved by this trial?
"This trial, lasting 6 months, aims to assess Penile Curvature. Secondary objectives include evaluating the International Index of Erectile Function Outcomes between control and treatment groups at 6 months, comparing Peyronie's Disease Questionnaire results from baseline and 12 months in control men (using 15 items; subdomains - psychological & physical (Q1-6, 0-24), penile pain (Q7-9; 0-30), symptom bother (Q10-15; 0-16); 12 & 14 Y/N q's)), as well as assessing any changes in penile length between the two groups over"
Are there any opportunities to join this research endeavor?
"Per the information on clinicaltrials.gov, this medical study is actively seeking applicants. The trial was initiated on September 20th 2021 and has undergone recent edits as of November 1st 2021."
Are there any precedents of CCH being used as part of a medical experiment?
"As of now, 6 clinical trials for CCH administration are still ongoing with one trial in Phase 3. Of the 11 study sites offering it, most are located in Orem, Utah."
For what purposes is CCH typically prescribed?
"CCH is commonly administered to treat palpable cord, as well as skin ulcers, peyronie's disease and penile deformities of up to 30 degrees."
How many participants are currently recruited into this clinical investigation?
"Affirmative. Clinicaltrials.gov shows that this trial is searching for volunteers, having been first posted on September 20th 2021 and last modified on November 1st 2021. 40 people are needed at the solitary site offering enrolment into the study."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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