Status:
COMPLETED
PRP for the Treatment of Erectile Dysfunction (ED)
Lead Sponsor:
Mayo Clinic
Conditions:
Erectile Dysfunction
Eligibility:
MALE
45-65 years
Phase:
PHASE1
Brief Summary
Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED).
Eligibility Criteria
Inclusion
- The patient must have given his informed and signed written consent
- The patient has ED for longer than 1 year but less than 5 years.
- The subject has a stable partner for at least 3 months.
- The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- IIEF-EF, EHS, SEP 2+3, and GAQ Domain score of 17-20 Mild to moderate vascular erectile dysfunction: PSV \> 25 cm/sec
Exclusion
- The patient is participating in another study that may interfere with the results or conclusions of this study
- History of radical prostatectomy or pelvic cancer surgery
- Prior history of pelvic malignancies
- Prior pelvic radiation therapy
- Neurological disease which effects erectile function (Spinal cord injury, iatrogenic injury to the pelvic or cavernous nerves)
- Psychiatric disease which effects erectile function
- The patient is taking blood thinners
- History of Diabetes Mellitus
- History of Coronary Artery Disease
- Evidence Based Criteria: Doppler Clinical Exam ( PSV \< 25 cm/sec defined criteria for severe erectile dysfunction not likely to respond to approved medical therapies)
- Biochemical evidence of Hypogonadism (total Testosterone \< 300 ng/dL)
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04350125
Start Date
March 4 2022
End Date
October 23 2023
Last Update
October 27 2023
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224