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Could a blood injection treat erectile dysfunction? new trial investigates

NCT ID NCT06768177

Disease control Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compares platelet-rich plasma (PRP) injections to the standard drug alprostadil (Caverject) for treating moderate to severe erectile dysfunction. Sixty men will receive both treatments in a crossover design, with each treatment given as six weekly injections. The main goal is to see if PRP improves erectile function scores more than alprostadil after 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Platelet-rich plasma (PRP) injection
What this could lead to
If PRP works, it could offer a new, natural treatment option for erectile dysfunction without relying on standard drugs.
What could go wrong
This is a small, early-stage crossover trial with only 60 participants. PRP is not yet proven for ED, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Nov 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

erectile dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction associated with type 2 diabetes mellitus Erectile dysfunction due to general medical condition Erectile dysfunction following radical prostatectomy Erectile dysfunctions

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico

    Bari, 70124, Italy

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Other studies related to the condition(s) this trial covers.