Platelet-Rich Plasma for Peyronie's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-20

Study Completion Date

2028-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Peyronie's Disease With Platelet-Rich Plasma

NCT06789510

Peyronies Disease

ACTIVE_NOT_RECRUITING NA

PRP for Treatment of Peyronie's Disease

NCT04512287

Peyronie Disease Sexual Dysfunction, Physiological Sexual Dysfunction Male +1 more

COMPLETED PHASE2

Stem Cell Treatment of Peyronie´s Disease.

NCT04771442

Penile Induration Penile Diseases

COMPLETED PHASE1

Microneedle Treatment of Chronic Phase Peyronie's Disease: A Pilot Clinical Trial

NCT07128420

Peyronie's Disease

ENROLLING_BY_INVITATION PHASE1

PRP for the Treatment of Erectile Dysfunction (ED)

NCT04350125

Erectile Dysfunction

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study protocol is structured such that participants, after being informed about the project and providing consent, will attend a baseline visit where relevant data will be collected from the participant, questionnaires, the patient's medical record, and through an objective examination. A total of 84 patients with Peyronie's disease will be included. Participants will be stratified based on the degree of penile curvature at baseline (30-60 degrees or \>60 degrees) and randomized in a 1:1 ratio to receive either active treatment with Platelet-Rich Plasma (PRP) or placebo (saline). Subsequently, participants will attend weekly injection sessions for 3 weeks consisting of either PRP or saline in a randomized, double-blind manner. A follow-up visit will take place three months after the final injection for outcome assessment. Two additional long-term follow-up visits will be conducted at 6 and 12 months post-treatment. Analysis will then be conducted.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peyronies Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Platelet Rich Plasma (PRP)

Group Type EXPERIMENTAL

Autologous Platelet Rich Plasma

Intervention Type 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.

Saline Solution (Placebo)

Group Type PLACEBO_COMPARATOR

Saline solution

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autologous Platelet Rich Plasma

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.

Intervention Type OTHER

Saline solution

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PRP Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No