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Efficacy of a Novel CCH Protocol for PD Among Prior Non-responders
Sponsor: Charitable Union for the Research and Education of Peyronie's Disease
Summary
Compare key clinical outcomes between controls and men treated with a novel CCH administration protocol among men previously unresponsive to CCH administration.
Official title: Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2021-09-20
Completion Date
2028-09-20
Last Updated
2025-02-13
Healthy Volunteers
No
Conditions
Interventions
CCH administration
Patients will be randomized 3:1 into the CCH administration arm. After undergoing baseline assessments, this arm will receive up to 8 CCH injections, followed by final assessments 6 weeks later.
Control - Crossover to CCH
Patients will be randomized 1:3 into the control arm. After undergoing baseline assessments, control men will not undergo treatments for 6 months. They will then have repeat assessments and receive up to 8 CCH injections. They will then have final assessments performed 6 weeks after treatment.
RestoreX
Both treatment arms will incorporate the use of RestoreX for 30-60 minutes daily during CCH administration and continued until 6 weeks after final injection administration.
Locations (1)
The Male Fertility and Peyronie's Clinic
Orem, Utah, United States