Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronie's Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Utah
Male Fertility and Peyronie's Clinic
RECRUITING
Orem
Contact Information
Primary
Landon Trost, MD
email@mfp.clinic
801-655-0015
Backup
Holli Burgon
burgon.holli@menshealthstudies.com
801-691-4714
Time Frame
Start Date: 2024-10-11
Estimated Completion Date: 2029-10
Participants
Target number of participants: 40
Treatments
Experimental: Primary Cohort
Men would receive 4 series of CCH injections:~* Administered on back-to-back days~* 0.9 mg administered with each series, diluted to 0.8 mL~* Mild in-office modeling performed on treatment day 2 of each series~* Wraps applied 2-4 full-time and 2-4 part-time days~* Sildenafil 25 mg nightly and Restorex beginning treatment day 2 (sildenafil) or 3 (Restorex - 30 min/day) until 6 weeks after final injection of the final series.~Note that men may stop sooner if they are satisfied before completing the 4 series. If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol.~* Performed 9-12 months after the 4th series of injections.~* The technique would incorporate more aggressive, in-office modeling.~* Men would receive up to two additional series per this protocol.
Related Therapeutic Areas
Sponsors
Collaborators: Endo Pharmaceuticals
Leads: Charitable Union for the Research and Education of Peyronie's Disease

This content was sourced from clinicaltrials.gov