Treatment of Peyronie's Disease With Platelet-Rich Plasma: A Pilot Study
Status: Active_not_recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this pilot study is to optimize a planned randomized, double-blind, placebo-controlled clinical trial evaluating the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase. The pilot study aims to identify potential challenges in the practical execution of the clinical trial, particularly regarding PRP preparation and the blinding process. Furthermore, it seeks to evaluate the effects of PRP injections.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years or older
• Be able to provide written informed consent
• Diagnosis of PD without active pain and without progressive curvature over the past 3 months (fibrotic phase).
• Penile curvature of 30-95 degrees
Locations
Other Locations
Denmark
Herlev and Gentofte University Hospital
Herlev
Time Frame
Start Date: 2025-03-10
Completion Date: 2026-01-01
Participants
Target number of participants: 10
Treatments
Experimental: Platelet Rich Plasma (PRP)
Each participant will receive 3 PRP injections over the 6-week period, with weekly injections in a randomized sequence. The RedCap randomization module will ensure that each participant receives 3 injections of each type.
Placebo_comparator: Saline Solution (Placebo)
Each participant will receive 3 saline injections over the 6-week period, with weekly injections in a randomized sequence. The RedCap randomization module will ensure that each participant receives 3 injections of each type.~In addition, Platelet-Rich Plasma (PRP) will be prepared but, instead of being injected, it will be analyzed for platelet count.
Related Therapeutic Areas
Sponsors
Leads: Herlev Hospital