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

NCT ID: NCT06768177

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-11-01

Brief 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.

Conditions

Erectile Dysfunction Due to General Medical Condition; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction Associated With Type 2 Diabetes Mellitus; Erectile Dysfunctions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

TREATMENT ARM

3 ML OF PRP

Group Type: EXPERIMENTAL

PRP injection

Intervention Type: DRUG

3 ML OF PRP

COMPARISON ARM

CAVERJECT 1 ML

Group Type: PLACEBO_COMPARATOR

Alprostadil 20 micrograms

Intervention Type: DRUG

1 ML

Interventions

PRP injection

3 ML OF PRP

Intervention Type: DRUG

Alprostadil 20 micrograms

1 ML

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, , Italy

Countries

Italy

Other Identifiers

PRP vs CAVERJECT - 2023

Identifier Type: -

Identifier Source: org_study_id