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Platelet Rich Plasma
Shockwave Therapy + Platelet Rich Plasma for Erectile Dysfunction (COCKTAIL Trial)
Phase 1
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 30 to 80 years of age (inclusive)
Be Male
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 3, month 6
Awards & highlights
COCKTAIL Trial Summary
This trial will study whether Shock Wave Therapy combined with Platelet Rich Plasma can improve erectile function by improving vasodilation and endothelial function in men with microvascular Erectile Dysfunction.
Who is the study for?
Men aged 30-80 with organic erectile dysfunction (ED) for at least 6 months, in a stable heterosexual relationship, willing to have regular intercourse without alcohol/drugs influence. Must not have psychological ED causes, significant penile abnormalities or surgeries, severe psychiatric disorders, uncontrolled diabetes, abnormal testosterone levels or use certain medications.Check my eligibility
What is being tested?
The study tests if Shock Wave Therapy (SWT) combined with Platelet Rich Plasma (PRP) can improve blood flow and repair blood vessel function in the penis. Participants will be randomly assigned to receive SWT + PRP, SWT alone, PRP alone or placebo treatments.See study design
What are the potential side effects?
Potential side effects may include pain at the injection site from PRP treatment and discomfort from SWT. There might also be bruising or swelling after the procedures. The severity of side effects varies among individuals.
COCKTAIL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 30 and 80 years old.
Select...
I am male.
COCKTAIL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 3, month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3, month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in IIEF-EF Scores
Circulating Angiogenic Factor levels
Penile Blood Flow
+1 moreSecondary outcome measures
Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors
COCKTAIL Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SWT plus PRP GroupExperimental Treatment2 Interventions
Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.
Group II: Sham SWT plus Placebo Saline GroupPlacebo Group2 Interventions
Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platelet Rich Plasma (PRP)
2015
Completed Phase 4
~330
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,365 Previous Clinical Trials
4,316,142 Total Patients Enrolled
1 Trials studying Erectile Dysfunction
568 Patients Enrolled for Erectile Dysfunction
University of MiamiLead Sponsor
905 Previous Clinical Trials
410,198 Total Patients Enrolled
6 Trials studying Erectile Dysfunction
541 Patients Enrolled for Erectile Dysfunction
Ranjith Ramasamy, MDPrincipal InvestigatorUniversity of Miami
12 Previous Clinical Trials
867 Total Patients Enrolled
4 Trials studying Erectile Dysfunction
286 Patients Enrolled for Erectile Dysfunction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must agree to comply with all study related tests/procedures.My testosterone levels are either below 300 ng/dL or above 1197 ng/dL.I am between 30 and 80 years old.I use injections for erectile dysfunction treatment.I have tried ED medications without success.I am male.You are willing to have sex at least 4 times a month during the study, without using alcohol or recreational drugs.I have been in a stable, heterosexual relationship for over three months.I have not used hormones except for testosterone, clomiphene, or thyroid meds.I have been in a stable, heterosexual relationship for over three months.I have had erectile dysfunction due to physical causes for at least 6 months.I have had penile surgery, excluding circumcision and condyloma removal.I have a physical or nerve condition in my genital area that affects my sex life.I have had erectile dysfunction due to physical causes for at least 6 months.I have a condition like severe diabetes, multiple sclerosis, or Parkinson's affecting my nerves.I have a history of significant psychiatric disease or am currently on SSRI or psychotropic medications.I am between 30 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: SWT plus PRP Group
- Group 2: Sham SWT plus Placebo Saline Group
Awards:
This trial has 0 awards, including: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.
Erectile Dysfunction Patient Testimony for trial: Trial Name: NCT05048667 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any additional participants needed for this research endeavor?
"Affirmative. Data hosted on clinicaltrials.gov attests that this medical experiment, which was initialised on June 27th 2022, is actively recruiting subjects. Approximately 60 participants are needed from 1 research centre."
Answered by AI
What is the total participant quota for this medical experiment?
"Affirmative. According to clinicaltrials.gov, this trial is currently enrolling participants and was first made available on June 27th 2022 with the most up-to-date changes occurring on September 12th of the same year. The said research aims to recruit 60 volunteers from a single site."
Answered by AI
Has the FDA sanctioned Shock Wave therapy (SWT) for public use?
"With limited evidence to support it, the safety rating of Shock Wave therapy (SWT) was appraised by our team at Power with a score of 1."
Answered by AI
What characteristics make someone a suitable candidate for this research initiative?
"This clinical trial seeks 60 participants aged 30 to 80 with erectile dysfunction. To be considered for inclusion, applicants must agree to: Attempt sexual intercourse at least 4 times per month without being impaired by alcohol/recreational drugs., Abide by all study related tests/procedures., Present an International Index of Erectile Function-Erectile Function score between 12 and 25 at screening, Have a diagnosis of ED due to organic origin for 6 months prior to voluntary consent.."
Answered by AI
Are individuals aged 35 and over eligible to become participants in this research?
"The guidelines for this trial dictate that the age range of eligible participants is between 30 and 80."
Answered by AI
Who else is applying?
What state do they live in?
California
Illinois
Other
Florida
How old are they?
18 - 65
What site did they apply to?
University of Miami Miller School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I've tried several ED medications with no success. I have noticed a difference in my lack of or very weak erection in the past two years .. I have tried the viagara and coal is and this gives me a headache.. even if I take the pill I notice it doesn’t last long.
PatientReceived 2+ prior treatments
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