Efficacy of a Novel CCH Protocol for PD Among Prior Non-responders

• Status: Recruiting
• Trial end date: 2028-09-20
• Target enrollment: 0
• Participant gender: Male

Summary

Compare key clinical outcomes between controls and men treated with a novel CCH administration protocol among men previously unresponsive to CCH administration.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charitable Union for the Research and Education of Peyronie's Disease

Criteria

Inclusion Criteria:

• Men with Peyronie's Disease

• >18 years old

• Curvature ≥30 degrees

• Previously completed 6-8 CCH injections

• Prior minimal (<20% and/or <10 degrees) responsiveness to CCH administration

• Prior CCH injections must have been performed without use of a Restorex traction device and used the IMPRESS protocol

• Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors

• The patient exhibits a palpable plaque consistent with Peyronie's Disease

Exclusion Criteria:

• Prior surgical treatment on the penis (other than circumcision)

• Any contraindications to CCH - as determined by the PI

• Inability to complete 8 additional CCH injections

• Severe plaque calcification (i.e. >1 cm shadowing)