PRP for Treatment of Peyronie's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Peyronie Disease, Sexual Dysfunction, Physiological, Sexual Dysfunction Male, Genital Diseases, Male

In brief

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

Key facts

Study ID

NCT04512287

Run by

University of Miami

People needed

65

Starts

2021-03-29

Expected to finish

2025-08-11

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Medically unfit for sexual intercourse as deemed by the principal investigator
• Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
• 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.

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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