Clinical Trials Logo
  1. Home
  2. Erectile Dysfunction
  3. NCT04357353
  4. Details
NCT04357353 Clinical Trial

The Role of Platelet Rich Plasma for Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:
The Role of Platelet Rich Plasma for Erectile Dysfunction

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04357353
Other study ID # 0156-20-FB
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date April 1, 2021
Est. completion date November 2, 2022

Study information
Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Purpose of Study: This randomized controlled trial investigates the role that platelet rich plasma injections into the penis may play to improve erectile function in men with erectile dysfunction.

Description:

Eligibility: Men with erectile dysfunction. Ages 50-80. International Index of Erectile Function score of mild (17-21/25) or moderate (8-16/25). Intervention and Evaluation:Men who consent to join the trial will be randomized to receive either a single injection PRP or saline to the penis. All patients will have blood drawn in clinic the day of injection. Those randomized to PRP arm will have their own blood prepared and separated into the PRP. This solution of their own blood will be injected back into the penis. Follow Up: Men will be evaluated at 1 , 3, and 6 months after the injections and then asked to complete the IIEF by phone or by electronic means

Recruitment information / eligibility
Status Terminated
Enrollment 13
Est. completion date November 2, 2022
Est. primary completion date November 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - history of mild to moderate erectile dysfunction measured by IIEF Exclusion Criteria: - history or prostate cancer treatment (prostatectomy, radiation, brachytherapy)

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Platelet rich plasma
PRP will be used in the experimental arm.
Other:
• Placebo Sham Injection
sham injection

Locations
Country Name City State
United States Unversity of Nebraska Medical Center Omaha Nebraska

Sponsors (1)
Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Side Effects any side effects noted by men at 1, 3 and 6 months
Primary Erectile Function Change The rate of change in erectile function measured by IIEF at 1, 3 and 6 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05366504 - LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment Phase 2/Phase 3
Recruiting NCT02573805 - the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males N/A
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Recruiting NCT02225548 - Sagene 2014 - Parkinson's Disease and Erectile Dysfunction Phase 4
Completed NCT02587988 - Trial to Evaluate the Efficacy and Safety of HCP1302 Phase 3
Completed NCT02945462 - Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED) Phase 1
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT01698684 - Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction Phase 4
Not yet recruiting NCT01321489 - A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies Phase 3
Terminated NCT01262833 - Pudendal Assessment in Erectile Dysfunction N/A
Completed NCT01230541 - Effect of Udenafil on Spermatogenesis Phase 1
Completed NCT02226237 - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy N/A
Completed NCT01037218 - Treatment of Erectile Dysfunction II Phase 3
Completed NCT01037244 - Treatment of Erectile Dysfunction I Phase 3
Recruiting NCT00313898 - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4
Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4