Platelet-Rich Plasma for Peyronie's Disease

NCT07117955 | Recruiting DMC

• 1 other identifier: H-24019622
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase.

Conditions

Peyronies Disease

Keywords

Andrology; Platelet-Rich Plasma; Penile induration; PRP

Outcome Measures

Primary Outcomes (1)

• Degree Changes in Penile Curvature.

  Dominant curvature angles will be measured bedside in the outpatient clinic using a goniometer following intracavernosal administration of Alprostadil to ensure high quality and consistency. At the same visit, standardized photographs of the erect penis will be captured (in two plans) to support objective assessment. These procedures will be performed at baseline and at follow-up three months after the final injection. At the 6- and 12-months long-term follow-up visits, no pharmacological erection induction will be performed. Instead, penile curvature will be assessed based on standardized photographs of the participant's erection taken at home following detailed instructions, allowing evaluation of the durability of any treatment effect.

  From enrollment to 12 months post intervention.

Secondary Outcomes (7)

• Changes in Plaque Size

  From enrollment to 12 months post intervention.

• Changes in the Peyronie's Disease Questionnaire (PDQ)

  From enrollment to 3 months post intervention.

• Changes in the Erection Hardness Score (EHS)

  From enrollment to 12 months post intervention.

• Changes in the Major Depression Inventory (MDI)

  From enrollment to 12 months post intervention.

• The Ability to Engage in Sexual Intercourse (question)

  From enrollment to 12 months post intervention.

Study Arms (2)

Platelet Rich Plasma (PRP)

EXPERIMENTAL

Other: Autologous Platelet Rich Plasma

Saline Solution (Placebo)

PLACEBO COMPARATOR

Other: Saline solution

Interventions

Autologous Platelet Rich Plasma OTHER

6 mL PRP intralesional injections will be administered. After the injections, participants will be instructed to perform penile stretching exercises daily until the next injection and to continue these exercises after the final injection until the 3-month follow-up.

Also known as: PRP

Platelet Rich Plasma (PRP)

Saline solution OTHER

6 mL saline solution intralesional injections will be administered. After the injections, participants will be instructed to perform penile stretching exercises daily until the next injection and to continue these exercises after the final injection until the 3-month follow-up.

Also known as: Placebo

Saline Solution (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Be able to provide written informed consent
• Diagnosis of PD without active pain and without progressive curvature over the past 3 months (fibrotic phase).
• Penile curvature of 30-95 degrees
• Clearly palpable penile plaque

You may not qualify if:

• 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 PD with injections and/or surgery.
• Antithrombotic therapy associated with a high risk of bleeding

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev and Gentofte University Hospital

Herlev, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Penile Induration

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

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

  Herlev and Gentofte University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Heering, MD, Ph.d. student

CONTACT

+4538688964; mikael.heering@regionh.dk

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

CONTACT

+4538682093; mikkel.mejlgaard.fode@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant and the investigator/treating doctor will be masked. The syringes will be covered. Only the care provider who prepare the PRP will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD-student

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)