Platelet-rich Plasma (PRP) Injection for Treatment of Erectile Function (NCT04050020) | Clinical Trial Compass
CompletedPhase 2/3
Platelet-rich Plasma (PRP) Injection for Treatment of Erectile Function
Greece60 participantsStarted 2019-09-02
Plain-language summary
The primary objective of the present study is to investigate and compare the treatment efficacy of PRP injection vs placebo treatment in men with mild-moderate vasculogenic ED, as measured by IIEF.The secondary objective of the present clinical trial is to study the adverse events and safety of the PRP injection treatment in vasculogenic ED patients
Who can participate
Age range40 Years – 70 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Consent to participate.
✓. Age 40-70 years.
✓. Sexually active in a stable, heterosexual relationship of more than three months duration.
✓. Presence of Erectile Dysfunction for at least 6 months.
✓. IIEF-ED: 11-25 at visit 1
✓. PDE5i users and report some/good response to PDE5i at the last month before screening.
✓. Agree to suspend all ED therapy for the duration of the study.
✓. Agree to attempt sexual intercourse at least 4 times every 4 weeks, for the duration of the study without being under the influence of alcohol or recreational drugs. Agree to document the outcome using the Sexual Encounter Profile (SEP) diary, as needed.
Exclusion criteria
✕. Previous major pelvic surgery or pelvic trauma that could impact erectile function, such as radical prostatectomy, radical cystectomy, rectal surgery. Patients with previous TURP surgery without sequelae of iatrogenic ED, may be included.
✕. Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, grafting.
✕. Previous history of priapism or penile fracture
✕. Previous radiation therapy to pelvis.
What they're measuring
1
The % of patients in each group who attain Minimal Clinically Important Difference (MCID) in International Index of Erectile Function -Erectile Function (IIEF-EF) domain from baseline to 24 weeks after final treatment.
Timeframe: at 24 weeks follow up visit
Trial details
NCT IDNCT04050020
SponsorInstitute for the Study of Urological Diseases, Greece
✕. 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%.
✕. 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.
✕. Psychogenic ED.
✕. Peyronie's Disease or penile curvature that negatively influences sexual activity.