Status:
ACTIVE_NOT_RECRUITING
Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's
Lead Sponsor:
Charitable Union for the Research and Education of Peyronie's Disease
Collaborating Sponsors:
Endo Pharmaceuticals
Conditions:
Peyronie's Disease
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare key clinical outcomes of collagenase clostridium histolyticum injections versus surgery for the management of Peyronie's Disease.
Detailed Description
After eligible patients have been informed about the study protocol and risks and consent have been given, men will be randomly assigned into either the collagenase clostridium histolyticum + penile t...
Eligibility Criteria
Inclusion
- Men with PD
- \>18 years old
- Curvature ≥30 degrees
- Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors
Exclusion
- Prior treatment with CCH or surgery
- Moderate (shadowing) or severe (\>1 cm) penile calcification
- Any contraindications to CCH, PTT, or surgery - as determined by the PI
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04786106
Start Date
December 30 2020
End Date
February 15 2027
Last Update
February 13 2025
Active Locations (1)
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1
The Male Fertility and Peyronie's Clinic
Orem, Utah, United States, 84057