Erectile Dysfunction Due to General Medical ConditionNCT06768177

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

A study testing PRP injection and Alprostadil 20 micrograms in people with Erectile Dysfunction Due to General Medical Condition and Erectile Dysfunction Following Radical Prostatectomy, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 30 years and older, men only
Conditions the study is for: Erectile Dysfunction Due to General Medical Condition, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
What is being tested?: PRP injection and Alprostadil 20 micrograms
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteItaly
Study dates: 1 Apr 2023to 1 Nov 2025
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site

Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, 70124

Other trials in Italy

About this study

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
Being tested: PRP injection, Alprostadil 20 micrograms
Medical subject headings: Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRP injectionDrug
3 ML OF PRP
Alprostadil 20 microgramsDrug
1 ML

Study groups in NCT06768177
Study group	Role	What they receive
TREATMENT ARM	Experimental	3 ML OF PRP Receives: Drug: PRP injection
COMPARISON ARM	Placebo comparator	CAVERJECT 1 ML Receives: Drug: Alprostadil 20 micrograms

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 24 WEEKS

Secondary outcomes (14)

EHS
Time frame: change from baseline and at 8 weeks, 16 weeks, and 24 weeks Any value above 0 (0 = The penis does not enlarge)
Measured: 24 WEEKS
The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with PRP
MCID (Minimal Clinically Important Differences) is defined on the severity of ED at baseline as:
- An improvement of 5 or more points in the IIEF score for patients with moderate ED (8-11) at baseline
- An improvement of 2 or more points in the IIEF score for patients with severe ED (5-7) at baseline
Measured: 24 WEEKS
The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with prostaglandin
MCID (Minimal Clinically Important Differences) is defined on the severity of ED at baseline as:
- An improvement of 5 or more points in the IIEF score for patients with moderate ED (8-11) at baseline
- An improvement of 2 or more points
Measured: 24 WEEKS
The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group.
The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group.
Measured: 24 WEEKS
SEP
Change in SEP:
- Response to questions 2 and 3 (SEP-Q2: Were you able to insert your penis into your partner's vagina? / SEP-Q3: Did your erection last long enough to allow you to have successful intercourse?)
- Change from baseline (= "YES" response) o At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)
Measured: 24 WEEKS
GAQ
Response to GAQ questions 1 and 2 (GAQ-Q1: Has the treatment you are taking improved your erectile function? / GAQ-Q2: If yes, has the treatment improved your ability to engage in sexual activity?) Change at T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) o Change from baseline (= "YES" response)
Measured: 24 WEEKS
QEQ
At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) o Improvement of 2 or more in the score
Measured: 24 WEEKS
Change in EDITS between PRP vs. prostaglandins
At T1 (2 weeks after the end of the first cycle) and T2 (2 weeks after the end of the second cycle)
Measured: At T1 (2 weeks after the end of the first cycle) and T2 (2 weeks after the end of the second cycle)
Change in TSS between PRP vs. prostaglandins
Change in TSS between PRP vs. prostaglandins at T3 (3 months after the end of the complete treatment)
Measured: 3 months after the end of the complete treatment
Change in SHIM
Change in SHIM
- At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)
- Improvement of 2 or more points in the score
Measured: 24 WEEKS
ECDPD - Peak Systolic Velocity (PSV)
ECDPD - Peak Systolic Velocity (PSV):
- To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)
- Recording of arterial penile velocity (cm/s) o Improvement in cm/s (any > 30 cm/s)
Measured: 24 WEEKS
ECDPD - Resistance Index (RI)
ECDPD - Resistance Index (RI):
- To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)
- Penile vascular resistance index (ratio) o Improvement (any increase up to the normal value - 0.9)
Measured: 24 WEEKS
ECDPD - End-Diastolic Velocity (EDV)
ECDPD - End-Diastolic Velocity (EDV):
- To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)
- Recording of residual flow in a vessel at the end of the diastolic phase (cm/s)
- Improvement in cm/s (any decrease in cm/s)
Measured: 24 WEEKS
Adverse events
Adverse events: Number of participants who experienced treatment-related adverse events.
Defined as: skin reaction (e.g., swelling, erythema, and warmth), discomfort at the injection site, penile pain, change in penile appearance, new sexual problems, and any systemic reaction observed by investigators or concerns expressed by patients o At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)
Measured: 24 WEEKS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20231 Nov 2025

First posted10 Jan 2025
Study start1 Apr 2023
Primary completion1 Nov 2024
Study completion1 Nov 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Erectile Dysfunction Due to General Medical ConditionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06768177
Sponsor's protocol ID: PRP vs CAVERJECT - 2023
Status last verified: Oct 2025
First submitted: 3 Dec 2024
Last updated: 2 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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