What is Platelet-Rich Plasma studying for Peyronie's disease?

Platelet-Rich Plasma is being studied to see how it affects penile curvature and other symptoms in men with Peyronie's disease during the fibrotic phase. The trial, sponsored by Herlev Hospital, aims to compare PRP injections to placebo to better understand potential treatment effects. Participants will be closely monitored over a year to assess changes.

Who may be eligible for this Peyronie's disease clinical trial?

Men aged 18 or older with a diagnosis of Peyronie's disease in the fibrotic phase and a penile curvature between 30 and 95 degrees may be eligible. Participants must have a clearly palpable penile plaque and no active pain or worsening curvature in the last 3 months. Please review eligibility criteria for more details.

Is there any cost to participate in this Peyronie's disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

MALE

ID07117955

Treatment of Peyronies Disease With Platelet-Rich Plasma A Randomized, Double-blind, Placebo-controlled Clinical Trial

Led by Herlev Hospital · Updated on 2025-08-14

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Platelet-Rich Plasma PRP injections in men diagnosed with Peyronies disease PD during its fibrotic phase. The study aims to assess how PRP may influence penile curvature and other related symptoms compared to a placebo treatment. A total of 84 male participants with specific degrees of penile curvature will be involved in this randomized, double-blind clinical trial. Participants are divided into two groups based on their penile curvature severity and randomized to receive either PRP or saline solution injections. Each participant will undergo weekly intralesional injections of 6 mL either PRP or saline for three weeks. Alongside the injections, all participants will perform daily penile stretching exercises from the first injection until the three-month follow-up. The trial includes a baseline visit, a three-month post-treatment follow-up, and additional long-term assessments at six and twelve months. Throughout the study, participants will have their penile curvature measured and evaluated at multiple points, including 12 months after treatment. Other outcomes assessed include plaque size, erectile hardness, depressive symptoms, ability to engage in sexual intercourse, preference for surgery, and global assessment scales. Data collection involves questionnaires, medical records, and physical examinations. This follow-up schedule allows researchers to monitor changes over time and analyze the effectiveness and safety of PRP treatment in this condition.

CONDITIONS

Brief Title

Platelet-Rich Plasma for Peyronie's Disease

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

18 years or older
Able to provide written informed consent
Diagnosis of Peyronie's disease without active pain and without progressive curvature over the past 3 months (fibrotic phase)
Penile curvature of 30 to 95 degrees
Clearly palpable penile plaque

You will not qualify if you...

Erectile dysfunction unresponsive to on-demand PDE5 inhibitors
Hourglass malformation
Severely calcified plaques where injection is considered unfeasible
Intrapenile plaque
History of priapism
History of penile fracture
Previous treatment for Peyronie's disease with injections and/or surgery
Antithrombotic therapy associated with a high risk of bleeding

Research Team

Mikael Heering, MD, Ph.d. student

Mikkel M. Fode, Professor, MD, Ph.d.

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