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Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
Sponsor: Charitable Union for the Research and Education of Peyronie's Disease
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.
Official title: Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronie's Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-10-11
Completion Date
2029-10
Last Updated
2025-02-13
Healthy Volunteers
No
Conditions
Interventions
Collagenase Clostridium Histolyticum
4 Series given to each participant, 6 weeks apart. Medication administered on back-to-back days. If failing to achieve an adequate response, men may receive up to 2 additional series 9-12 months after the 4th series. Total of 0.9 mg administered with each series, diluted to 0.8 mL
RestoreX
Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final CCH series.
Sildenafil
Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.
Locations (1)
Male Fertility and Peyronie's Clinic
Orem, Utah, United States