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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 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.
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.
Conditions Studied
Interventions
- DRUG Collagenase Clostridium Histolyticum
- DEVICE RestoreX
- DRUG Sildenafil
Study Locations (1)
Utah
- Male Fertility and Peyronie's Clinic - Orem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-10-11 |
| Est. Completion | 2029-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06649539
The ClinicalTrials.gov registry entry for NCT06649539 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 54-participant average among 3 other Peyronie Disease trials with a reported enrollment target (26% lower). The listed sponsor is Charitable Union for the Research and Education of Peyronie's Disease, which has 6 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.