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Clinical Trials in Italy / NCT06768177
Enrolling by invitation Not applicable

Platelet Rich Plasma (PRP) as Terapeutical Option in Erectil Disfunction (DE)

NCT06768177 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Phase
Not applicable
Started
2023-04-01
Last updated
2025-10-02

Condition(s) studied

Erectile Dysfunction Due to General Medical ConditionErectile Dysfunction Following Radical ProstatectomyErectile Dysfunction Associated With Type 2 Diabetes MellitusErectile Dysfunctions

Investigational drug(s) / intervention(s)

PRP injectionAlprostadil 20 micrograms

PRP injection: 3 ML OF PRP

Alprostadil 20 micrograms: 1 ML

Study summary

Patients are randomized into 2 groups (A and B), subsequently group A is subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP while group B is subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg. After 4 (four) weeks the groups will be crossed, so group A will be subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg while group B will be subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP.

Eligibility

Sex
MALE
Min age
30 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Moderate to severe erectile dysfunction (IIEF-5 score below 17) * Patients previously treated with first- and second-line therapies for ED * Patients who have undergone radical pelvic surgery with nerve sparing * Good pharmacological blood pressure control * Well-controlled diabetes on medication * Current or former smokers * Good renal function even with the use of medications * Well-controlled hypertriglyceridemia and/or hypercholesterolemia even with the use of medications * BMI less than or equal to 35 * Normal levels of FSH, LH, PRL, Total Testosterone, and TSH Exclusion Criteria: * Patients on antidepressant, anxiolytic, sedative, or antipsychotic medications. * Consumers of more than 500 g of alcohol per day. * BMI greater than 35 * Altered levels of FSH, LH, PRL, Total Testosterone, and TSH.

Primary outcome measure(s)

  • Change in erectile function — 24 WEEKS
    Change in erectile function defined as the % of patients in each group achieving MCID in the IIEF-EF domain from baseline to 24 weeks (i.e. 12 weeks after the end of full treatment): * MCID (Minimal clinically important differences) is based on the severity of ED at baseline as: * Improvement of 5 or points more in IIEF score for patients with moderate ED (8-11) at baseline * Improvement of 2 or more points in IIEF score for patients with severe ED (5-7) at baseline

Trial sites (1)

FacilityCityRegionStatus
Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico Bari Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06768177 on ClinicalTrials.gov ↗ ← All trials in Italy