CompletedPhase 2

PRP for Treatment of Peyronie's Disease

United States65 participantsStarted 2021-03-29

Plain-language summary

The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).

Age range18 Years – 75 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Be Male
✓. Be 18 to 75 years of age (inclusive).
✓. Be able to provide written informed consent
✓. Have a diagnosis of PD with evidence of active or stable disease as determined by the investigator
✓. Penile curvature deformity of \>30° to \<120°
✓. Agree to comply with all study related tests/procedures.

✕. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
✕. Previous intralesional injection therapy (such as Xiaflex) for PD.
✕. Previous history of priapism or penile fracture
✕. PD characterized by a ventral plaque
✕. Severe erectile dysfunction as characterized with an International Index of Erectile Function (IIEF) score ≤ 16
✕. Actively on anticoagulation during time frame of injections (aspirin 81 mg will be eligible for therapy)
✕. Hour-glass deformity
✕. Unwilling to participate

Percentage of subjects in each group who attain degree change in penile curvature.

Timeframe: 7 months

Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).

Timeframe: 7 months

NCT IDNCT04512287

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-11