Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
Recruiting now · Phase 4
Conditions studied: Peyronie Disease
In brief
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.
Key facts
- Study ID
- NCT06649539
- Run by
- Charitable Union for the Research and Education of Peyronie's Disease
- People needed
- 40
- Starts
- 2024-10-11
- Expected to finish
- 2029-10-01
- Last updated by the study team
- 2025-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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
- For partners, the only inclusion criteria is being willing to complete a questionnaire
You may not qualify if…
- Prior surgical treatment on the penis (other than circumcision)
- Prior treatment with CCH injections
- Any contraindications to CCH - as determined by the PI
Where it is running
- Male Fertility and Peyronie's Clinic — Orem, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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