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PRP for Treatment of Peyronie's Disease

NCT04512287 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-08-03

No results posted yet for this study

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).

Conditions

  • Peyronie Disease
  • Sexual Dysfunction, Physiological
  • Sexual Dysfunction Male
  • Genital Diseases, Male

Interventions

BIOLOGICAL

Autologous Platelet-Rich Plasma (PRP)

Autologous platelet-rich plasma (PRP) prepared from the participant's own blood. Participants will receive 2 treatment sessions administered 15 ± 7 days apart, with 0.5 mL of PRP injected into the Peyronie's disease penile plaque at each session.

OTHER

Placebo (Normal Saline)

Normal saline administered as a placebo comparator. Participants will receive 2 treatment sessions administered 15 ± 7 days apart, with 0.5 mL of normal saline injected into the Peyronie's disease penile plaque at each session.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Manuel Molina, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2025-08-11
Completion
2025-08-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04512287 on ClinicalTrials.gov