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Enzyme

Collagenase Injections for Peyronie's Disease

Phase 4

Recruiting

Led By Landon Trost, MD

Research Sponsored by Charitable Union for the Research and Education of Peyronie's Disease

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Older than 18 years old

The patient exhibits a palpable plaque consistent with Peyronie's Disease

Must not have

Prior treatment with CCH injections

Prior surgical treatment on the penis (other than circumcision)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to evaluate a new injection protocol for men who did not respond well to previous treatments. Participants will receive up to 4 series of injections and use a device and medication daily. The study

Who is the study for?

This trial is for men with Peyronie's Disease who didn't respond to initial treatments. They'll receive up to 4 series of CCH injections, followed by possible additional treatments. Partners can join the study too and will fill out questionnaires.

What is being tested?

The trial tests a new protocol using Collagenase Clostridium Histolyticum (CCH) injections combined with in-office modeling, RestoreX device use, and daily Sildenafil. It aims to see if this approach is safe and works better than past methods.

What are the potential side effects?

Possible side effects from CCH may include swelling, pain at the injection site, bruising or bleeding. RestoreX might cause discomfort due to stretching, while Sildenafil can lead to headaches, flushing or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I have a noticeable lump in my penis that is diagnosed as Peyronie's Disease.

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I am a man with Peyronie's Disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received CCH injections before.

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I have had surgery on my penis, not including circumcision.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Penile Curvature

Penile Length

Secondary study objectives

Adverse Events

Compliance with Therapy - Penile Curvature

Compliance with Therapy - Penile Length

+6 more

Awards & Highlights

Drug Has Already Been Approved

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

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Primary CohortExperimental Treatment3 Interventions

Men would receive 4 series of CCH injections: * Administered on back-to-back days * 0.9 mg administered with each series, diluted to 0.8 mL * Mild in-office modeling performed on treatment day 2 of each series * Wraps applied 2-4 full-time and 2-4 part-time days * Sildenafil 25 mg nightly and Restorex beginning treatment day 2 (sildenafil) or 3 (Restorex - 30 min/day) until 6 weeks after final injection of the final series. Note that men may stop sooner if they are satisfied before completing the 4 series. If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol. * Performed 9-12 months after the 4th series of injections. * The technique would incorporate more aggressive, in-office modeling. * Men would receive up to two additional series per this protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sildenafil

2008

Completed Phase 4

~1690

Collagenase Clostridium Histolyticum

2013

Completed Phase 3

~1010