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

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Treatment Related Adverse Events

Percent change of penile curvature in degrees.

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

Do I qualify?Apply below to find out