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Platelet-Rich Plasma
PRP for Peyronie's Disease
Phase 2
Recruiting
Led By Ranjith Ramasamy, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18 to 75 years of age (inclusive)
Be 18 to 75 years of age (inclusive).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months
Awards & highlights
Study Summary
This trial is testing whether an injection of Platelet-Rich Plasma (PRP) can improve symptoms in men with Peyronie's Disease (PyD).
Who is the study for?
Men aged 18-75 with Peyronie's Disease, having a penile curvature between 30° and 120°. Candidates must be able to consent, follow study procedures, and have no serious illnesses that affect participation. Excluded are those with hour-glass deformity, prior penile surgeries (other than circumcision), on strong anticoagulants, or unfit for sexual activity.Check my eligibility
What is being tested?
The trial is investigating the effects of injecting Platelet-Rich Plasma (PRP) into men with Peyronie's Disease compared to saline solution injections. The goal is to see if PRP can improve the condition.See study design
What are the potential side effects?
Possible side effects may include pain at injection site, minor bleeding or bruising due to needle insertion, infection risk at the injection area, and allergic reactions to components in PRP.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I am between 18 and 75 years old.
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I have Parkinson's disease with active or stable symptoms.
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I am male.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
Curvature of spine
Secondary outcome measures
Incidence of adverse events in all patients
Side effects data
From 2023 Phase 2 trial • 61 Patients • NCT043967954%
Reproductive system and breast disorders - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
PRP Group
Trial Design
2Treatment groups
Experimental Treatment
Group I: Experimental: Placebo followed by Autologous PRP GroupExperimental Treatment2 Interventions
Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 3 months later.
Group II: Experimental: Autologous PRP followed by Placebo GroupExperimental Treatment2 Interventions
Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Platelet Rich Plasma
2022
Completed Phase 2
~210
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
409,996 Total Patients Enrolled
2 Trials studying Peyronie's Disease
102 Patients Enrolled for Peyronie's Disease
Ranjith Ramasamy, MDPrincipal Investigator - University of Miami
Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami Hospital
12 Previous Clinical Trials
847 Total Patients Enrolled
1 Trials studying Peyronie's Disease
80 Patients Enrolled for Peyronie's Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a planned medical procedure that might affect my PRP therapy.I am between 18 and 75 years old.You have had a previous occurrence of priapism (a painful, prolonged erection) or a penile fracture.I have not had penile surgery, except for circumcision or condyloma removal.I have Peyronie's disease with a plaque on the front side of my penis.I am currently taking blood thinners, but aspirin 81 mg is okay.The doctor in charge thinks you are not healthy enough to have sex.I have had injections directly into my Peyronie’s disease lesions before.I am between 18 and 75 years old.You have severe difficulty in getting or maintaining an erection, as measured by a test called International Index of Erectile Function (IIEF) score, which is less than or equal to 16.I have an hour-glass shaped deformity.I have Parkinson's disease with active or stable symptoms.Your penis has a curve that is too severe or not severe enough.I am willing to participate in the trial.You agree to comply with all study related tests/procedures.I am male.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Autologous PRP followed by Placebo Group
- Group 2: Experimental: Placebo followed by Autologous PRP Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are eligible for inclusion in this research project?
"Absolutely. According to clinicaltrials.gov, this trial was initially advertised on March 29th 2021 and has been recently updated on November 21st 2022. 80 people are required for the study from a single site."
Answered by AI
Does the research project include individuals in their seventies as participants?
"The cut-off age for recruitment into this trial is 18 years old, while the maximum participation age is 75."
Answered by AI
What has been the Food and Drug Administration's stance on Autologous Platelet Rich Plasma?
"Autologous Platelet Rich Plasma was assigned a safety rating of 2, as there is evidence validating its safety but no data backing the efficacy of this therapy from Phase 2 clinical trials."
Answered by AI
Are investigators actively seeking participants for this research?
"Affirmative. Clinicaltrials.gov attests that this clinical trial, first posted on March 29th 2021, is currently in search of 80 volunteers from one medical facility. The most recent update was made November 21st 2022."
Answered by AI
What are the eligibility criteria for participation in this clinical investigation?
"This clinical trial will be enrolling 80 male patients aged between 18 and 75 who have been diagnosed with a genital-related medical condition. The key eligibility criteria include the willingness to comply with all study related tests/procedures, as well as being within the specified age range (18-75)."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Colorado
How old are they?
18 - 65
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- University of Miami: < 24 hours
Average response time
- < 1 Day
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