Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Autologous Platelet Rich Plasma; Saline solution
Intervention description: Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum.; Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: Male
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ED

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)
    

Eligibility 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%.