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Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.

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ClinicalTrials.gov Identifier: NCT04396795
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Ranjith Ramasamy, MD, University of Miami

Study Description
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Brief Summary:
The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Autologous Platelet Rich Plasma Other: Saline solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control, Double-Blind, Placebo Controlled, Multicenter Clinical Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma Injection Treatment for Erectile Dysfunction.
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PRP group
Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days
 Drug: Autologous Platelet Rich Plasma
Each injection session will consist of a total of 10 mL PRP infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.
Other Name: PRP
Placebo Comparator: Placebo group
Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.
 Other: Saline solution
Each injection session will consist of a total of 10 mL saline solution infused slowly over a 2-minute period; 5 mL s each injected to the right and left corpus cavernosum


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants achieving MCID in IIEF-EF [ Time Frame: 9 weeks ]
    Treatment efficacy of PRP will be assessed via the percentage of participants achieving mild clinically important difference (MCID) in their IIEF-EF scores from baseline to 4 weeks after final treatment. International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. MCID is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED.


Secondary Outcome Measures :
  1. Percentage of participants achieving MCID in IIEF-EF [ Time Frame: 24 weeks ]
    Treatment efficacy of PRP will be assessed via the percentage of participants achieving MCID in their IIEF-EF scores from baseline to 2 and 24 weeks after final treatment. IIEF-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. MCID is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED.

  2. Change in IIEF-EF Scores [ Time Frame: Baseline up to Week 9, Baseline up to Week 17, Baseline up to Week 29 ]
    IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.

  3. Change in doppler ultrasound parameters [ Time Frame: Baseline, Up to 29 weeks ]
    Change in Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) assessed in cm/sec via ultrasound.

  4. Incidence of adverse events [ Time Frame: 24 weeks ]
    Safety will be evaluated via the incidence of adverse events as assessed by treating physician


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be Male
  2. Be 30 to 75 years of age (inclusive).
  3. Be able to provide written informed consent.
  4. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
  5. Sexually active in a stable, heterosexual relationship of more than three months duration.
  6. IIEF-EF score 11-25 at screening (even if taking a single PDE5).
  7. Agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
  8. Agree to comply with all study related tests/procedures.

Exclusion Criteria:

  1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
  2. Previous history of priapism or penile fracture
  3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
  4. Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
  5. Psychogenic ED as determined by study investigator.
  6. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
  7. Patients using Intra Cavernous Injection (ICI)for management of ED
  8. Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
  9. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
  10. History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
  11. Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitor or psychotropic medications.
  12. Hemoglobin a1c >9%.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396795


Contacts
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Contact: Thomas Masterson, MD 305-243-4562 tmasterson@med.miami.edu
Contact: Ranjith Ramasamy, MD 305-243-4562 ramasamy@miami.edu

Locations
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United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Ranjith Ramasamy, MD    305-243-4562    ramasamy@miami.edu   
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Ranjith Ramasamy, MD University of Miami
More Information
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Publications:

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Responsible Party: Ranjith Ramasamy, MD, Director of Male Fertility and Andrology, University of Miami, University of Miami
ClinicalTrials.gov Identifier: NCT04396795    
Other Study ID Numbers: 20200373
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ranjith Ramasamy, MD, University of Miami:
ED
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders