Recruiting PHASE4 Peyronie Disease

New treatment option for Peyronie Disease

Official title Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease

ClinicalTrials.gov ID: NCT06649539

What this study is testing

What is Collagenase Clostridium Histolyticum?

Collagenase Clostridium Histolyticum is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for peyronie disease.

Also referred to as Xiaflex, CCH.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Men with Peyronie's Disease
  • Older than 18 years old
  • Curvature ≥30 degrees
  • Ability to achieve an erection satisfactory for intercourse with or without phosphodiesterase-5 (PDE5) inhibitors
  • The patient exhibits a palpable plaque consistent with Peyronie's Disease

You likely can't join if

  • Prior surgical treatment on the penis (other than circumcision)
  • Prior treatment with CCH injections
  • Any contraindications to CCH - as determined by the PI
See the full eligibility criteria
Who can join
  • Men with Peyronie's Disease
  • Older than 18 years old
  • Curvature ≥30 degrees
  • Ability to achieve an erection satisfactory for intercourse with or without phosphodiesterase-5 (PDE5) inhibitors
  • The patient exhibits a palpable plaque consistent with Peyronie's Disease
  • For partners, the only is being willing to complete a questionnaire
What rules you out
  • Prior surgical treatment on the penis (other than circumcision)
  • Prior treatment with CCH injections
  • Any contraindications to CCH - as determined by the PI

The study team makes the final eligibility decision.

Where it's taking place

  • Orem, Utah, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Orem, Utah, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.