NCT06768177

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

October 2, 2025

Status Verified

October 1, 2025

Enrollment Period

1.6 years

First QC Date

December 3, 2024

Last Update Submit

October 1, 2025

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Change in erectile function

    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

    24 WEEKS

Secondary Outcomes (14)

  • EHS

    24 WEEKS

  • The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with PRP

    24 WEEKS

  • The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with prostaglandin

    24 WEEKS

  • The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group.

    24 WEEKS

  • SEP

    24 WEEKS

  • +9 more secondary outcomes

Study Arms (2)

TREATMENT ARM

EXPERIMENTAL

3 ML OF PRP

Drug: PRP injection

COMPARISON ARM

PLACEBO COMPARATOR

CAVERJECT 1 ML

Drug: Alprostadil 20 micrograms

Interventions

PRP injectionDRUG

3 ML OF PRP

TREATMENT ARM
Alprostadil 20 microgramsDRUG

1 ML

COMPARISON ARM

Eligibility Criteria

Age30 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

January 10, 2025

Study Start

April 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2025

Last Updated

October 2, 2025

Record last verified: 2025-10

Locations

IT(1)