NCT04396795

Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.

A Randomized Control, Double-Blind, Placebo Controlled, Multicenter Clinical Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma Injection Treatment for Erectile Dysfunction.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Autologous Platelet Rich Plasma	Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum.
OTHER	Saline solution	Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum

Timeline

• Start date: 2020-05-21
• Primary completion: 2023-01-23
• Completion: 2023-04-18
• First posted: 2020-05-21
• Last updated: 2024-01-09
• Results posted: 2024-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study