Status:
COMPLETED
Treatment Response to Xiaflex for Men With Peyronie's Disease
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Endo Pharmaceuticals
Conditions:
Peyronie Disease
Eligibility:
MALE
18+ years
Brief Summary
The purpose of this research study is to develop a database of patients with Peyronie's disease who are treated at the University of Miami. The collected data will help the researchers to better under...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Able to provide informed consent
- A stable relationship for ≥3 months
- PD symptoms with evidence of stable disease as determined by the investigator
- Penile curvature deformity of \>30° to \<90°
- Has not had previous surgery for PD
- Has not had previous therapy with Xiaflex for PD
Exclusion
- Ventral plaque
- Active phase PD
- Actively on anticoagulation during time frame of injections
- Aspirin 81mg will be eligible for therapy
- Hour glass deformity
- Previous allergic reaction to Xiaflex
- Unwilling to participate
- Medically unfit for sexual intercourse as deemed by the principal investigator
- Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with Xiaflex injection cycles as deemed by the PI
Key Trial Info
Start Date :
September 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 2 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03774264
Start Date
September 2 2018
End Date
July 2 2021
Last Update
September 29 2021
Active Locations (1)
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1
Department of Urology, University of Miami
Miami, Florida, United States, 33136