Peyronie DiseasePhase 2NCT04512287
PRP for Treatment of Peyronie's Disease
A Phase 2 study testing Autologous Platelet-Rich Plasma (PRP) in people with Peyronie Disease and Sexual Dysfunction, Physiological, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Peyronie Disease, Sexual Dysfunction, Physiological, Sexual Dysfunction Male
- What is being tested?
- Autologous Platelet-Rich Plasma (PRP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to 11 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be Male
- Be 18 to 75 years of age (inclusive).
- Be able to provide written informed consent
- Have a diagnosis of PD with evidence of active or stable disease as determined by the investigator
- Penile curvature deformity of >30° to <120°
- Agree to comply with all study related tests/procedures.
Who cannot join
- Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
- Previous intralesional injection therapy (such as Xiaflex) for PD.
- Previous history of priapism or penile fracture
- PD characterized by a ventral plaque
- Severe erectile dysfunction as characterized with an International Index of Erectile Function (IIEF) score ≤ 16
- Actively on anticoagulation during time frame of injections (aspirin 81 mg will be eligible for therapy)
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- Hour-glass deformity
- Unwilling to participate
- Medically unfit for sexual intercourse as deemed by the principal investigator
- Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
- Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Crossover Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma for Treatment of Peyronie's Disease
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
- Being tested
- Autologous Platelet-Rich Plasma (PRP), Placebo (Normal Saline)
- Keywords
- PD, PyD, PRP
- Medical subject headings
- Penile Induration, Sexual Dysfunction, Physiological, Genital Diseases, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-Rich Plasma (PRP)Biological
Also called 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.
Placebo (Normal Saline)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Autologous PRP followed by Placebo Group | Experimental | Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later. Receives: Biological: Autologous Platelet-Rich Plasma (PRP); Other: Placebo (Normal Saline) |
| Experimental: Placebo followed by Autologous PRP Group | Experimental | Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 3 months later. Receives: Biological: Autologous Platelet-Rich Plasma (PRP); Other: Placebo (Normal Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 7 months
Secondary outcomes (1)
Incidence of adverse events in all patients
Safety will be evaluated via the incidence of adverse events as assessed by treating physician
Measured: Baseline, 6 months (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start29 Mar 2021
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Molina Leyba, University of Miami
- Investigators
- Manuel Molina, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512287
- Sponsor's protocol ID
- 20200779
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2020
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chu KY, Molina ML, Ledesma B, Zucker I, Saltzman RG, Masterson TA, Ramasamy R. A Phase 2 Randomized, Placebo-controlled Crossover Trial to Evaluate Safety and Efficacy of Platelet-rich Plasma Injections for Peyronie's Disease: Clinical Trial Update. Eur Urol Focus. 2023 Jan;9(1):11-13. doi: 10.1016/j.euf.2022.08.017. Epub 2022 Sep 10.
PubMed 36100520
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Crossover Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma for Treatment of Peyronie's Disease
- ClinicalTrials.gov ID
- NCT04512287
- Acronym / sponsor ID
- 20200779
- Conditions
- Peyronie Disease, Sexual Dysfunction, Physiological, Sexual Dysfunction Male, Genital Diseases, Male
- Keywords
- PD, PyD, PRP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Autologous PRP followed by Placebo Group | Experimental | Biological: Autologous Platelet-Rich Plasma (PRP), Other: Placebo (Normal Saline)Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later. |
| Experimental: Placebo followed by Autologous PRP Group | Experimental | 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be Male
- Be 18 to 75 years of age (inclusive).
- Be able to provide written informed consent
- Have a diagnosis of PD with evidence of active or stable disease as determined by the investigator
- Penile curvature deformity of >30° to <120°
Key exclusion criteria (11 listed)
- Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
- Previous intralesional injection therapy (such as Xiaflex) for PD.
- Previous history of priapism or penile fracture
- PD characterized by a ventral plaque
- Severe erectile dysfunction as characterized with an International Index of Erectile Function (IIEF) score ≤ 16
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet-Rich Plasma (PRP)Also: PRPAutologous 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. | Biological | Experimental: Autologous PRP followed by Placebo Group, Experimental: Placebo followed by Autologous PRP Group |
| 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. | Other | Experimental: Autologous PRP followed by Placebo Group, Experimental: Placebo followed by Autologous PRP Group |
Primary outcome
Percentage of subjects in each group who attain degree change in penile curvature.
Time frame: 7 months
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.
Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
Time frame: 7 months
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).
1 secondary outcome
Incidence of adverse events in all patients
Time frame: Baseline, 6 months (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Derived from this study: PubMed 36100520Chu KY, Molina ML, Ledesma B, Zucker I, Saltzman RG, Masterson TA, Ramasamy R. A Phase 2 Randomized, Placebo-controlled Crossover Trial to Evaluate Safety and Efficacy of Platelet-rich Plasma Injections for Peyronie's Disease: Clinical Trial Update. Eur Urol Focus. 2023 Jan;9(1):11-13. doi: 10.1016/j.euf.2022.08.017. Epub 2022 Sep 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Molina, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Platelet-Rich Plasma (PRP) in people with Peyronie Disease and Sexual Dysfunction, Physiological, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects in each group who attain degree change in penile curvature. (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04512287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.