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.
Trial 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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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
Show all 10Show fewer
- 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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma (PRP) as Terapeutical Option in Erectil Disfunction (DE)
- ClinicalTrials.gov ID
- NCT06768177
- Acronym / sponsor ID
- PRP vs CAVERJECT - 2023
- Conditions
- Erectile Dysfunction Due to General Medical Condition, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Erectile Dysfunctions
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TREATMENT ARM | Experimental | Drug: PRP injection3 ML OF PRP |
| COMPARISON ARM | Placebo comparator | Drug: Alprostadil 20 microgramsCAVERJECT 1 ML |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP injection3 ML OF PRP | Drug | TREATMENT ARM |
| Alprostadil 20 micrograms1 ML | Drug | COMPARISON ARM |
Primary outcome
Change in erectile function
Time frame: 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
14 secondary outcomes
EHS
Time frame: 24 WEEKS
The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with PRP
Time frame: 24 WEEKS
The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with prostaglandin
Time frame: 24 WEEKS
The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group.
Time frame: 24 WEEKS
SEP
Time frame: 24 WEEKS
GAQ
Time frame: 24 WEEKS
QEQ
Time frame: 24 WEEKS
Change in EDITS between PRP vs. prostaglandins
Time frame: 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
Time frame: 3 months after the end of the complete treatment
Change in SHIM
Time frame: 24 WEEKS
ECDPD - Peak Systolic Velocity (PSV)
Time frame: 24 WEEKS
ECDPD - Resistance Index (RI)
Time frame: 24 WEEKS
ECDPD - End-Diastolic Velocity (EDV)
Time frame: 24 WEEKS
Adverse events
Time frame: 24 WEEKS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in erectile function (time frame: 24 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.