<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04502875</url>
  </required_header>
  <id_info>
    <org_study_id>PRePED</org_study_id>
    <nct_id>NCT04502875</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Evaluate the Efficacy of Intracavernosal Infusion of PRP vs PPP for the Erectile Dysfunction.</brief_title>
  <acronym>PRePED</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Puerta de Hierro University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Puerta de Hierro University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, double-blind clinical trial to evaluate efficacy, feasibility and safety with two&#xD;
      groups in a 1:1 ratio; where the control group corresponds to patients who will receive&#xD;
      Platelet Poor plasma and an experimental group where patients will receive Platelet Rich&#xD;
      Plasma, both collected by apheresis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients treated in the urology department of the Hospital Universitario Puerta de Hierro&#xD;
      Majadahonda, are eligible and will be offered the participation in this clinical trial.&#xD;
&#xD;
      The target populations are patients who presented erectile dysfunction for at least 6 months&#xD;
      with an IIEF-EF between 5 and 16 points. They will be pre-screened for eligibility.&#xD;
&#xD;
      The patient must complete the informed consent form (ICF) process and sign and date the&#xD;
      informed consent form prior to participation in this study, including completion of any&#xD;
      non-standard-of- care procedures required for this clinical Investigation.&#xD;
&#xD;
      If the patient meets the inclusion criteria and additionally meet with the apheresis&#xD;
      procedures, the patient wil be included in the study.&#xD;
&#xD;
      The study include two phases. In the first phase, the patient will be randomized to PPP or&#xD;
      PPP. In the second phase, according with the score IIEF-EF (responder or non responder), the&#xD;
      patient will receive PRP.&#xD;
&#xD;
      With the responders patients, an open phase with PDE5-Is is initiated. The patient will use&#xD;
      phosphodiesterase 5 inhibitors (PDE5-Is) at maximum tolerated doses according with the&#xD;
      Summary Product of characteristics.&#xD;
&#xD;
      With the no responders patients, there will be two options:&#xD;
&#xD;
      If the non-responder patient was in treatment with PRP during the firs phase, the patient&#xD;
      will continue with the procedures of visits 11a and 12a.&#xD;
&#xD;
      If the non-responder patient was in treatment with PPP, the patient will start the second&#xD;
      phase of treatment with PRP and will continue with the procedures of this treatment phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 10, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of increments between PRP and PPP treatment assessed by IIEF scale</measure>
    <time_frame>28 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events related with the use of PRP/PPP</measure>
    <time_frame>28 weeks</time_frame>
    <description>Incidence of infusion related Adverse Events (AEs) and cumulative of incidence of Serious Adverse Events (SAEs) during the clinical trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synergic efficcacy of PRP and PDE5 inhibitors</measure>
    <time_frame>28 weeks</time_frame>
    <description>Assessment of the synergic efficacy of PRP treatment on the therapeutic response to oral administration of PDE5 inhibitors by the IIEF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of cytokines and growth factors in the PRP and PPP</measure>
    <time_frame>28 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intracavernosal infusion of Platelet Rich Plasma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intracavernosal infusion of Platelet Poor Plasma</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRP</intervention_name>
    <description>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.</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PPP</intervention_name>
    <description>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.</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed an ethics committee-reviewed and approved informed consent form.&#xD;
&#xD;
          -  Subjects must meet all inclusion criteria to be eligible for study enrollment.&#xD;
&#xD;
          -  Men between 40 and 75 years old, with a relationship of more than 6 months of&#xD;
             duration.&#xD;
&#xD;
          -  Erectile dysfunction for at least 6 months with an IIEF-EF (while using the higher&#xD;
             tolerated dose of PDE5-Is) between 5 and 16 points, inclusive.&#xD;
&#xD;
          -  Erectile dysfunction of vascular origin. In case of clinical doubt or incongruence, a&#xD;
             Nocturnal Penile Tumescence and Rigidity Test (NPTR) will be performed. In this case,&#xD;
             criteria inclusion is having no event in the night with a penile rigidity (tip) of&#xD;
             ≥70% during ≥5min.&#xD;
&#xD;
          -  Subjects agree to attempt vaginal intercourse at least 4 times every month after the&#xD;
             end of the treatment and agree to document the outcome using the Sexual Encounter&#xD;
             Profile (SEP) and the Erection Hardness Score (EHS).&#xD;
&#xD;
          -  Commitment not to use other treatment for ED during the study (herbal, topical,&#xD;
             intraurethral, intracavernosal, etc.).&#xD;
&#xD;
          -  Commitment to completing the rest of the questionnaires and other measurement&#xD;
             instruments during the study phase.&#xD;
&#xD;
          -  Willingness and ability to comply with study procedures, other measurements&#xD;
             instruments and visit schedules and able to follow oral and written instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented psychogenic erectile dysfunction (with NPTR test: at least one event in the&#xD;
             night with a penile rigidity (tip) of ≥70% during ≥5min).&#xD;
&#xD;
          -  Erectile dysfunction of neurogenic origin (radical prostatectomy, pelvic surgery,&#xD;
             spinal cord injury, multiple sclerosis, diabetes mellitus is not included unless&#xD;
             documented diabetic neuropathy).&#xD;
&#xD;
          -  Some other current sexual dysfunction (premature ejaculation, etc.).&#xD;
&#xD;
          -  Prior implant of penile prosthesis or other penile surgeries different to&#xD;
             circumcision, frenuloplasty or condyloma removal.&#xD;
&#xD;
          -  Previous history of penile fracture, Peyronie's disease or priapism.&#xD;
&#xD;
          -  History of radical prostatic or bladder surgery (radical cystectomy or prostatectomy).&#xD;
&#xD;
          -  Previous radiation to pelvis.&#xD;
&#xD;
          -  History of symptomatic hypogonadism (testosterone level &lt;346ng/dl) not treated. If&#xD;
             treated hypogonadism, testosterone levels non-stable for at least 3 months.&#xD;
&#xD;
          -  Major hematologic, renal, or hepatic abnormalities.&#xD;
&#xD;
          -  Severe decompensated cardiac and vascular insufficiency, or critical coronary heart&#xD;
             disease.&#xD;
&#xD;
          -  Poorly controlled hypertension or diabetes mellitus (HbA1c &gt;12%).&#xD;
&#xD;
          -  Recent (within previous six months of the inclusion) stroke or myocardial infarction.&#xD;
&#xD;
          -  Active peptic ulcer disease.&#xD;
&#xD;
          -  Neoplasm of any origin in active treatment or active progression.&#xD;
&#xD;
          -  History of psychiatric pathology (depressive syndrome, schizophrenia, bipolar&#xD;
             disorder).&#xD;
&#xD;
          -  History of alcohol abuse (More than 7 alcohol drink units a week or more than 3 per&#xD;
             occasion) or drug abuse (any drug consumption different to alcohol or tobacco, used&#xD;
             more than three times per month).&#xD;
&#xD;
          -  Treatment with oral anticoagulants (dicoumarin or by-products) or antiandrogens.&#xD;
&#xD;
          -  Active treatment as nitric oxide (NO) donor drugs.&#xD;
&#xD;
          -  Prior positive serology to HBsAg, HCV (by genomic test), HIV-1/2, syphilis.&#xD;
&#xD;
          -  Thrombopenia less than 100 x 109 / L.&#xD;
&#xD;
          -  Anemia (Hemoglobin &lt;13 g/dl).&#xD;
&#xD;
          -  Poor venous access or any other circumstance that preclude an apheresis procedure.&#xD;
&#xD;
          -  Lack of sexual practices in recent months (less than 4 attempts in the last three&#xD;
             months).&#xD;
&#xD;
          -  Lack of commitment on the part of the patient to attend the tests requested.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Martinez-Salamanca, Md, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Urologist</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juan Ignacio Martínez-Salamanca, MD, PhD</last_name>
    <phone>+34 91 191 71 95</phone>
    <email>jims@lyxurologia.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gustavo Centeno, MD, PhD</last_name>
    <phone>91 191 6026</phone>
    <email>gustavoadolfo.centeno@salud.madrid.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Puerta de Hierro University Hospital</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gustavo Centeno, MD</last_name>
      <phone>91 191 6026</phone>
      <email>gustavoadolfo.centeno@salud.madrid.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Puerta de Hierro University Hospital</investigator_affiliation>
    <investigator_full_name>Juan Ignacio Martinez Salamanca</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Platelet Rich Plasma</keyword>
  <keyword>Platelet Poor Plasma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04502875
org study id: PRePED
nct id: NCT04502875
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Difference of increments between PRP and PPP treatment assessed by IIEF scale
time frame: 28 weeks
description: 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.
measure: Incidence of adverse events related with the use of PRP/PPP
time frame: 28 weeks
description: Incidence of infusion related Adverse Events (AEs) and cumulative of incidence of Serious Adverse Events (SAEs) during the clinical trial.
measure: Synergic efficcacy of PRP and PDE5 inhibitors
time frame: 28 weeks
description: Assessment of the synergic efficacy of PRP treatment on the therapeutic response to oral administration of PDE5 inhibitors by the IIEF.
measure: Concentration of cytokines and growth factors in the PRP and PPP
time frame: 28 weeks
description: 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.
arm group label: Treatment Arm
arm group type: Experimental
description: Intracavernosal infusion of Platelet Rich Plasma
arm group label: Control Arm
arm group type: Active Comparator
description: Intracavernosal infusion of Platelet Poor Plasma
intervention type: Drug
intervention name: PRP
description: 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.
arm group label: Treatment Arm
intervention type: Drug
intervention name: PPP
description: 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.
arm group label: Control Arm
criteria: 
gender: Male
gender based: Yes
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Juan Martinez-Salamanca, Md, PhD
role: Principal Investigator
affiliation: Urologist
last name: Juan Ignacio Martínez-Salamanca, MD, PhD
phone: +34 91 191 71 95
email: jims@lyxurologia.com
last name: Gustavo Centeno, MD, PhD
phone: 91 191 6026
email: gustavoadolfo.centeno@salud.madrid.org
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Puerta de Hierro University Hospital
investigator full name: Juan Ignacio Martinez Salamanca
investigator title: Principal Investigator
mesh term: Erectile Dysfunction
sharing ipd: No