A Phase 2 interventional study of Autologous Platelet-Rich Plasma (PRP) and Placebo (Normal Saline) in Peyronie Disease, Sexual Dysfunction, Physiological and Sexual Dysfunction Male, sponsored by University of Miami. Completed at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by University of Miami · Phase 2, Interventional, and Treatment
The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).
47 studies on the registry are indexed under Penile Induration; 10 are open to participants now.
This study's enrollment of 65 is above the median of 40 across 39 interventional studies indexed under Penile Induration.
Browse Penile Induration studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later.
Biological: Autologous Platelet-Rich Plasma (PRP) · Other: Placebo (Normal Saline)
Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 3 months later.
Biological: Autologous Platelet-Rich Plasma (PRP) · Other: Placebo (Normal Saline)
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.
Also known as: PRP
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.
Percentage of subjects in each group who attain degree change in penile curvature.
Treatment efficacy of PRP will be assessed via the percentage of participants achieving degree change in penile curvature from baseline. Degree of curvature will be measured using a goniometer with the aid of injection of vasoactive substance into the penis.
Time frame: 7 months
Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
Treatment efficacy will be assessed via the percentage of participants achieving any decrease in Peyronie's disease Questionnaire (PDQ) sub-domain scoring from baseline. The sub-domains that will be assessed in primary outcome is Psychological and Physical Symptoms and Symptom Bother. PDQ is a validated 15-item questionnaire that assess Psychological and Physical Symptoms, Symptom Bother, and Penile Pain subdomains. The Psychological and Physical Symptoms subdomain is measured from 0 to 24 (most severe symptoms). Symptom Bother subdomain is measured from 0 to 30 (most severe pain).
Time frame: 7 months
Incidence of adverse events in all patients
Safety will be evaluated via the incidence of adverse events as assessed by treating physician
Time frame: Baseline, 6 months (post-intervention)
Plan to share: No
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Platelet rich plasma