Erectile DysfunctionPhase 2PRePEDNCT04502875
Clinical Trial to Evaluate the Efficacy of Intracavernosal Infusion of PRP vs PPP for the Erectile Dysfunction.
A Phase 2 study testing PRP and PPP in people with Erectile Dysfunction, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
Randomized, double-blind clinical trial to evaluate efficacy, feasibility and safety with two groups in a 1:1 ratio; where the control group corresponds to patients who will receive Platelet Poor plasma and an experimental group where patients will receive Platelet Rich Plasma, both collected by apheresis. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- PRP and PPP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2020to 31 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed an ethics committee-reviewed and approved informed consent form.
- Subjects must meet all inclusion criteria to be eligible for study enrollment.
- Men between 40 and 75 years old, with a relationship of more than 6 months of duration.
- Erectile dysfunction for at least 6 months with an IIEF-EF (while using the higher tolerated dose of PDE5-Is) between 5 and 16 points, inclusive.
- Erectile dysfunction of vascular origin. In case of clinical doubt or incongruence, a Nocturnal Penile Tumescence and Rigidity Test (NPTR) will be performed. In this case, criteria inclusion is having no event in the night with a penile rigidity (tip) of ≥70% during ≥5min.
- Subjects agree to attempt vaginal intercourse at least 4 times every month after the end of the treatment and agree to document the outcome using the Sexual Encounter Profile (SEP) and the Erection Hardness Score (EHS).
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- Commitment not to use other treatment for ED during the study (herbal, topical, intraurethral, intracavernosal, etc.).
- Commitment to completing the rest of the questionnaires and other measurement instruments during the study phase.
- Willingness and ability to comply with study procedures, other measurements instruments and visit schedules and able to follow oral and written instructions.
Who cannot join
- Documented psychogenic erectile dysfunction (with NPTR test: at least one event in the night with a penile rigidity (tip) of ≥70% during ≥5min).
- Erectile dysfunction of neurogenic origin (radical prostatectomy, pelvic surgery, spinal cord injury, multiple sclerosis, diabetes mellitus is not included unless documented diabetic neuropathy).
- Some other current sexual dysfunction (premature ejaculation, etc.).
- Prior implant of penile prosthesis or other penile surgeries different to circumcision, frenuloplasty or condyloma removal.
- Previous history of penile fracture, Peyronie's disease or priapism.
- History of radical prostatic or bladder surgery (radical cystectomy or prostatectomy).
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- Previous radiation to pelvis.
- History of symptomatic hypogonadism (testosterone level <346ng/dl) not treated. If treated hypogonadism, testosterone levels non-stable for at least 3 months.
- Major hematologic, renal, or hepatic abnormalities.
- Severe decompensated cardiac and vascular insufficiency, or critical coronary heart disease.
- Poorly controlled hypertension or diabetes mellitus (HbA1c >12%).
- Recent (within previous six months of the inclusion) stroke or myocardial infarction.
- Active peptic ulcer disease.
- Neoplasm of any origin in active treatment or active progression.
- History of psychiatric pathology (depressive syndrome, schizophrenia, bipolar disorder).
- History of alcohol abuse (More than 7 alcohol drink units a week or more than 3 per occasion) or drug abuse (any drug consumption different to alcohol or tobacco, used more than three times per month).
- Treatment with oral anticoagulants (dicoumarin or by-products) or antiandrogens.
- Active treatment as nitric oxide (NO) donor drugs.
- Prior positive serology to HBsAg, HCV (by genomic test), HIV-1/2, syphilis.
- Thrombopenia less than 100 x 109 / L.
- Anemia (Hemoglobin <13 g/dl).
- Poor venous access or any other circumstance that preclude an apheresis procedure.
- Lack of sexual practices in recent months (less than 4 attempts in the last three months).
- Lack of commitment on the part of the patient to attend the tests requested.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Puerta de Hierro University Hospital
Majadahonda, Madrid, 28222
Gustavo Centeno, MD, 91 191 6026, gustavoadolfo.centeno@salud.madrid.org
About this study
Official title: A Randomized, Double-blind Controlled Trial to Evaluate the Efficacy of Intracavernosal Infusion of Platelet Rich Plasma Against Platelet Poor Plasma in the Treatment of Vasculogenic Erectile Dysfunction.
Randomized, double-blind clinical trial to evaluate efficacy, feasibility and safety with two groups in a 1:1 ratio; where the control group corresponds to patients who will receive Platelet Poor plasma and an experimental group where patients will receive Platelet Rich Plasma, both collected by apheresis.
Read the detailed description
Patients treated in the urology department of the Hospital Universitario Puerta de Hierro Majadahonda, are eligible and will be offered the participation in this clinical trial.
The target populations are patients who presented erectile dysfunction for at least 6 months with an IIEF-EF between 5 and 16 points. They will be pre-screened for eligibility.
The patient must complete the informed consent form (ICF) process and sign and date the informed consent form prior to participation in this study, including completion of any non-standard-of- care procedures required for this clinical Investigation.
If the patient meets the inclusion criteria and additionally meet with the apheresis procedures, the patient wil be included in the study.
The study include two phases. In the first phase, the patient will be randomized to PPP or PPP. In the second phase, according with the score IIEF-EF (responder or non responder), the patient will receive PRP.
With the responders patients, an open phase with PDE5-Is is initiated. The patient will use phosphodiesterase 5 inhibitors (PDE5-Is) at maximum tolerated doses according with the Summary Product of characteristics.
With the no responders patients, there will be two options:
If the non-responder patient was in treatment with PRP during the firs phase, the patient will continue with the procedures of visits 11a and 12a.
If the non-responder patient was in treatment with PPP, the patient will start the second phase of treatment with PRP and will continue with the procedures of this treatment phase.
- Conditions
- Erectile Dysfunction
- Being tested
- PRP, PPP
- Keywords
- Platelet Rich Plasma, Platelet Poor Plasma
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPDrug
Platelet Rich Plasma (PRP) is an autologous blood component derivate from the own patient blood, with a high concentration in platelets. The liquid fraction obtained after the soft centrifugation of Whole Blood (WB) collected with anticoagulant, in a way that most of the red cells and leukocytes are sedimented and removed, but most of the platelets are kept in the supernatant plasma. The platelet concentration in PRP is not well defined.
PPPDrug
PPP is the liquid fraction obtained after the hard centrifugation of WB collected with any anticoagulant. PPP does not contain cells. (Hematocrit lower than 1% and leukocytes below 1 x 109/L) x but contains WB proteins (including clotting factors), ions, microelements and water. PPP can be also being collected using an apheresis technique.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Intracavernosal infusion of Platelet Rich Plasma Receives: Drug: PRP |
| Control Arm | Active comparator | Intracavernosal infusion of Platelet Poor Plasma Receives: Drug: PPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of increments between PRP and PPP treatment assessed by IIEF scale
Difference of increments between both treatment groups assesed by International Index Erectile Function (IIEF) scale (referred to the investigator's study as mean PRP V9(PT)IIEF-EF - V3IIEF-EF vs mean PPP V9(PT)IIEF-EF - V3IIEF-EF) after 4 weeks of the end of the treatment.
Measured: 28 weeks
Secondary outcomes (3)
Incidence of adverse events related with the use of PRP/PPP
Incidence of infusion related Adverse Events (AEs) and cumulative of incidence of Serious Adverse Events (SAEs) during the clinical trial.
Measured: 28 weeks
Synergic efficcacy of PRP and PDE5 inhibitors
Assessment of the synergic efficacy of PRP treatment on the therapeutic response to oral administration of PDE5 inhibitors by the IIEF.
Measured: 28 weeks
Concentration of cytokines and growth factors in the PRP and PPP
Concentration of cytokines and growth factors concentration in the PRP and PPP of each patient and their relationship with the clinical response to PRP assessed by IIEF.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start10 Feb 2020
- Primary completion28 Feb 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind clinical trial to evaluate efficacy, feasibility and safety with two groups in a 1:1 ratio; where the control group corresponds to patients who will receive PPP and an experimental group where patients will receive PRP, both collected by apheresis.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Ignacio Martinez Salamanca, Puerta de Hierro University Hospital
- Investigators
- Juan Martinez-Salamanca, Md, PhD, Principal investigator, Urologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502875
- Sponsor's protocol ID
- PRePED
- Acronym
- PRePED
- Status last verified
- Aug 2020
- First submitted
- 16 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Controlled Trial to Evaluate the Efficacy of Intracavernosal Infusion of Platelet Rich Plasma Against Platelet Poor Plasma in the Treatment of Vasculogenic Erectile Dysfunction.
- ClinicalTrials.gov ID
- NCT04502875
- Acronym / sponsor ID
- PRePED / PRePED
- Conditions
- Erectile Dysfunction
- Keywords
- Platelet Rich Plasma, Platelet Poor Plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 6 Aug 2020 (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.
Randomized, double-blind clinical trial to evaluate efficacy, feasibility and safety with two groups in a 1:1 ratio; where the control group corresponds to patients who will receive Platelet Poor plasma and an experimental group where patients will receive Platelet Rich Plasma, both collected by apheresis.
Detailed description
Patients treated in the urology department of the Hospital Universitario Puerta de Hierro Majadahonda, are eligible and will be offered the participation in this clinical trial.
The target populations are patients who presented erectile dysfunction for at least 6 months with an IIEF-EF between 5 and 16 points. They will be pre-screened for eligibility.
The patient must complete the informed consent form (ICF) process and sign and date the informed consent form prior to participation in this study, including completion of any non-standard-of- care procedures required for this clinical Investigation.
If the patient meets the inclusion criteria and additionally meet with the apheresis procedures, the patient wil be included in the study.
The study include two phases. In the first phase, the patient will be randomized to PPP or PPP. In the second phase, according with the score IIEF-EF (responder or non responder), the patient will receive PRP.
With the responders patients, an open phase with PDE5-Is is initiated. The patient will use phosphodiesterase 5 inhibitors (PDE5-Is) at maximum tolerated doses according with the Summary Product of characteristics.
With the no responders patients, there will be two options:
If the non-responder patient was in treatment with PRP during the firs phase, the patient will continue with the procedures of visits 11a and 12a.
If the non-responder patient was in treatment with PPP, the patient will start the second phase of treatment with PRP and will continue with the procedures of this treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind clinical trial to evaluate efficacy, feasibility and safety with two groups in a 1:1 ratio; where the control group corresponds to patients who will receive PPP and an experimental group where patients will receive PRP, both collected by apheresis.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: PRPIntracavernosal infusion of Platelet Rich Plasma |
| Control Arm | Active comparator | Drug: PPPIntracavernosal infusion of Platelet Poor Plasma |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed an ethics committee-reviewed and approved informed consent form.
- Subjects must meet all inclusion criteria to be eligible for study enrollment.
- Men between 40 and 75 years old, with a relationship of more than 6 months of duration.
- Erectile dysfunction for at least 6 months with an IIEF-EF (while using the higher tolerated dose of PDE5-Is) between 5 and 16 points, inclusive.
- Erectile dysfunction of vascular origin. In case of clinical doubt or incongruence, a Nocturnal Penile Tumescence and Rigidity Test (NPTR) will be performed. In this case, criteria inclusion is having no event in the night with a penile rigidity (tip) of ≥70% during ≥5min.
Key exclusion criteria (24 listed)
- Documented psychogenic erectile dysfunction (with NPTR test: at least one event in the night with a penile rigidity (tip) of ≥70% during ≥5min).
- Erectile dysfunction of neurogenic origin (radical prostatectomy, pelvic surgery, spinal cord injury, multiple sclerosis, diabetes mellitus is not included unless documented diabetic neuropathy).
- Some other current sexual dysfunction (premature ejaculation, etc.).
- Prior implant of penile prosthesis or other penile surgeries different to circumcision, frenuloplasty or condyloma removal.
- Previous history of penile fracture, Peyronie's disease or priapism.
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 |
|---|---|---|
| PRPPlatelet Rich Plasma (PRP) is an autologous blood component derivate from the own patient blood, with a high concentration in platelets. The liquid fraction obtained after the soft centrifugation of Whole Blood (WB) collected with anticoagulant, in a way that most of the red cells and leukocytes are sedimented and removed, but most of the platelets are kept in the supernatant plasma. The platelet concentration in PRP is not well defined. | Drug | Treatment Arm |
| PPPPPP is the liquid fraction obtained after the hard centrifugation of WB collected with any anticoagulant. PPP does not contain cells. (Hematocrit lower than 1% and leukocytes below 1 x 109/L) x but contains WB proteins (including clotting factors), ions, microelements and water. PPP can be also being collected using an apheresis technique. | Drug | Control Arm |
Primary outcome
Difference of increments between PRP and PPP treatment assessed by IIEF scale
Time frame: 28 weeks
Difference of increments between both treatment groups assesed by International Index Erectile Function (IIEF) scale (referred to the investigator's study as mean PRP V9(PT)IIEF-EF - V3IIEF-EF vs mean PPP V9(PT)IIEF-EF - V3IIEF-EF) after 4 weeks of the end of the treatment.
3 secondary outcomes
Incidence of adverse events related with the use of PRP/PPP
Time frame: 28 weeks
Synergic efficcacy of PRP and PDE5 inhibitors
Time frame: 28 weeks
Concentration of cytokines and growth factors in the PRP and PPP
Time frame: 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Juan Martinez-Salamanca, Md, PhD principal investigator
Urologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRP and PPP in people with Erectile Dysfunction, run by Puerta de Hierro University Hospital at 1 site in Spain.
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 9 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 6 Aug 2020. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Ignacio Martínez-Salamanca, MD, PhD (+34 91 191 71 95, jims@lyxurologia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of increments between PRP and PPP treatment assessed by IIEF scale (time frame: 28 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 6 Aug 2020.