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Platelet Rich Plasma

Autologous Platelet Rich Plasma for Erectile Dysfunction

Phase 2

Waitlist Available

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 older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 3 month, 6 month

Awards & highlights

Study Summary

This trial is testing whether a treatment involving Platelet Rich Plasma (PRP) can improve vascular parameters and International Index of Erectile Function (IIEF) scores in participants with Erectile Dysfunction (ED).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month, 3 month, 6 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month, 3 month, 6 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 3 month, 6 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Achieving MCID in IIEF-EF.

Secondary outcome measures

Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV)

Change in IIEF-EF Scores

Number of Adverse Events

+1 more

Side effects data

From 2023 Phase 2 trial • 61 Patients • NCT04396795

Reproductive system and breast disorders - Other, specify

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Group

PRP Group

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PRP groupExperimental Treatment1 Intervention

Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days

Group II: Placebo groupPlacebo Group1 Intervention

Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Autologous Platelet Rich Plasma

2022

Completed Phase 2

~210

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

901 Previous Clinical Trials

409,925 Total Patients Enrolled

6 Trials studying Erectile Dysfunction

540 Patients Enrolled for Erectile Dysfunction

Ranjith Ramasamy, MDPrincipal Investigator - University of Miami

Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami Hospital

12 Previous Clinical Trials

866 Total Patients Enrolled

4 Trials studying Erectile Dysfunction

285 Patients Enrolled for Erectile Dysfunction

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How do I know if I am eligible to participate in this research project?

"This study is currently looking for 80 individuals aged 30-75 that have been struggling with organic erectile dysfunction for at least half a year. Eligible participants should be willing and able to attempt intercourse 4 times a month during the duration of the trial, agree to follow all study procedures, and have an IIEF-EF score of 11-25."

Answered by AI

Has the Autologous Platelet Rich Plasma procedure received government sanctioning?

"Autologous Platelet Rich Plasma is currently in Phase 2 of clinical trials. While there is some evidence supporting its safety, none yet exists to suggest that it is an effective treatment."

Answered by AI

Would elderly patients be appropriate for this particular type of research?

"To be included in this research, patients must between 30 and 75 years old. If you are under 18 years old or over 65, there are other clinical trials that may be a better fit."

Answered by AI

Could you tell me if this research is still enrolling participants?

"This particular clinical trial, which was initially advertised on May 21st 2020, is not currently enrolling patients. However, there are 65 other medical studies that are actively looking for participants."

Answered by AI

Recent research and studies

Nature Reviews RheumatologyJournal

Platelet-rich Plasma for Managing Pain and Inflammation in Osteoarthritis

Andia, Isabel, and Nicola Maffulli. 2013. “Platelet-rich Plasma for Managing Pain and Inflammation in Osteoarthritis”. Nature Reviews Rheumatology. Springer Science and Business Media LLC. doi:10.1038/nrrheum.2013.141.

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Randelli, Pietro, Filippo Randelli, Vincenza Ragone, Alessandra Menon, Riccardo D’Ambrosi, Davide Cucchi, Paolo Cabitza, and Giuseppe Banfi. 2014. “Regenerative Medicine in Rotator Cuff Injuries”. Biomed Research International. Hindawi Limited. doi:10.1155/2014/129515.

Physiological ReviewsJournal

Regulation of Wound Healing by Growth Factors and Cytokines

WERNER, SABINE, and RICHARD GROSE. 2003. “Regulation of Wound Healing by Growth Factors and Cytokines”. Physiological Reviews. American Physiological Society. doi:10.1152/physrev.2003.83.3.835.

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