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NCT06649539 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Peyronie Disease, sponsored by Charitable Union for the Research and Education of Peyronie's Disease.

Recruiting
Registry status
Phase 4
Development phase
40
Enrollment target
1
Study location

NCT06649539: Recruiting Phase 4 study of Peyronie Disease, sponsored by Charitable Union for the Research and Education of Peyronie's Disease.

NCT06649539 is a Phase 4 study of Peyronie Disease that is actively recruiting participants, run by Charitable Union for the Research and Education of Peyronie's Disease. The registered enrollment target is 40 participants, below the 54-participant average among 3 other Peyronie Disease trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06649539, a Phase 4 study of Peyronie Disease, is actively recruiting participants, sponsored by Charitable Union for the Research and Education of Peyronie's Disease.

RECRUITING
Registry status
Phase 4
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

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. Participants will receive up to 4 series of CCH injections using our previously published protocol, with mild in-office modeling. CCH injections are given on back-to back days, after which they are counseled to utilize Restorex and sildenafil daily, as instructed. Patients will undergo mild in-office modeling on day 2. The sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patient's treatment.

Primary Outcome

Compare penile curvature between baseline and post-treatment in men 1 year after completing the final injection series. A goniometer (protractor) will be used to measure from the penile angulation during a full erection in two planes (dorsal/ventral and lateral). Measurements will be in degrees.

Conditions Studied

Peyronie Disease

Interventions

  • DRUG Collagenase Clostridium Histolyticum
  • DEVICE RestoreX
  • DRUG Sildenafil

Study Locations (1)

Utah

  • Male Fertility and Peyronie's Clinic - Orem

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-10-11
Est. Completion 2029-10
Phase Phase 4
Charitable Union for the Research and Education of Peyronie's Disease

6 total trials

What NCT06649539 shows while recruiting

NCT06649539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 54-participant average among 3 other Peyronie Disease trials with a reported enrollment target (26% lower).

The record links to 1 condition, with Peyronie Disease appearing as the primary indexed condition, and to 3 interventions - of which Collagenase Clostridium Histolyticum is the first listed.

NCT06649539 reports a single indexed study location in Utah.

Frequently Asked Questions

What is clinical trial NCT06649539 about?

NCT06649539 is a clinical study titled "Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease". 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 ...

What is the current status of trial NCT06649539?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2024-10-11. Estimated completion is 2029-10.

What conditions does trial NCT06649539 study?

This clinical trial studies the following conditions: Peyronie Disease.

What interventions are being tested in trial NCT06649539?

The interventions under investigation include: Collagenase Clostridium Histolyticum (DRUG), RestoreX (DEVICE), Sildenafil (DRUG).

Who is sponsoring clinical trial NCT06649539?

This trial is sponsored by Charitable Union for the Research and Education of Peyronie's Disease, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06649539 being conducted?

This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06649539

Source: ClinicalTrials.gov NCT06649539, the US trial registry maintained by the National Library of Medicine. NCT06649539 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.