Peyronies DiseaseNCT06789510
Treatment of Peyronie's Disease With Platelet-Rich Plasma
A study testing Autologous Platelet Rich Plasma and Saline solution in people with Peyronies Disease, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of this pilot study is to optimize a planned randomized, double-blind, placebo-controlled clinical trial evaluating the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronies Disease
- What is being tested?
- Autologous Platelet Rich Plasma and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Mar 2025to 31 Oct 2025
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Erectile Dysfunction unresponsive to on-demand PDE5 inhibitors
- Hourglass malformation
- Severely calcified plaques where injection is considered unfeasible
- History of priapism.
- History of penile fracture.
- Previous treatment for PD with injections and/or surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Peyronie's Disease With Platelet-Rich Plasma: A Pilot Study
The purpose of this pilot study is to optimize a planned randomized, double-blind, placebo-controlled clinical trial evaluating the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase. The pilot study aims to identify potential challenges in the practical execution of the clinical trial, particularly regarding PRP preparation and the blinding process. Furthermore, it seeks to evaluate the effects of PRP injections.
Read the detailed description
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. Subsequently, participants will attend weekly injection sessions for 6 weeks, during which they will receive 3 PRP injections and 3 saline injections (placebo) in a randomized order. Three months after the final injection, participants will attend a follow-up visit, where the final data will be collected. Analysis will then be conducted.
- Conditions
- Peyronies Disease
- Being tested
- Autologous Platelet Rich Plasma, Saline solution
- Keywords
- PRP, Platelet-Rich Plasma
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet Rich PlasmaOther
Also called PRP
10 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 solutionOther
Also called Placebo
10 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.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma (PRP) | Experimental | Each participant will receive 3 PRP injections over the 6-week period, with weekly injections in a randomized sequence. The RedCap randomization module will ensure that each participant receives 3 injections of each type. Receives: Other: Autologous Platelet Rich Plasma |
| Saline Solution (Placebo) | Placebo comparator | Each participant will receive 3 saline injections over the 6-week period, with weekly injections in a randomized sequence. The RedCap randomization module will ensure that each participant receives 3 injections of each type.
In addition, Platelet-Rich Plasma (PRP) will be prepared but, instead of being injected, it will be analyzed for platelet count. Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Concentration in the PRP
In the placebo sessions, the Platelet-Rich Plasma (PRP) sample (prepared using the Magellan Autologous Platelet Separator) will be sent for analysis of platelet concentration levels to ensure the quality of the PRP.
Measured: The 6 week intervention period.
Evaluation of the Blinding Process
After each injection, both the administering physician and the participant will be asked to state whether they believe the injection contained PRP or saline. They will also be asked to justify their response, which will allow for adjustments to the practical implementation of the blinding process in the Randomized Controlled Trial (RCT), if necessary.
Measured: The 6 week intervention period.
Secondary outcomes (9)
Adverse Events
Recording of adverse events following injections to ensure safety. In other studies and clinical practice, no serious adverse events have been reported. However, mild adverse events may include slight pain, ecchymosis, and hematoma.
Measured: From the first injection to the 3 months post intervention follow-up.
Degree Changes in Penile Curvature.
Dominant curvature angles will be measured using a goniometer based on images of the participants' erect penis (in two planes) at baseline and at follow-up three months after the final injection. The images will be captured in the outpatient clinic following the administration of Alprostadil to ensure high quality and consistency.
Measured: From enrollment to 3 months post intervention.
Changes in Plaque Size
Plaque size will be measured at baseline and three months after the final injection using a ruler, calculated as the product of plaque length and width. Participants with more than two plaques or with significant plaque heterogeneity will not have plaque size measured and will be excluded from these analyses but may still participate in the study.
Measured: From enrollment to 3 months post intervention.
Changes in the Peyronie's Disease Questionnaire (PDQ)
The Peyronie's Disease Questionnaire (PDQ) is a 15-question self-reported survey that measures the impact and severity of Peyronie's disease (PD) symptoms in 3 domains, including psychological and physical symptoms, penile pain and symptom bother.
Higher domain scores indicate a greater negative impact. The range of scores for each domain is 0 to 24 for PD psychological and physical symptoms, 0 to 30 for penile pain and 0 to 16 for PD symptom bother.
The participants will complete the survey at baseline and three months after the final injection.
Measured: From enrollment to 3 months post intervention.
Changes in the Erection Hardness Score (EHS)
The participants will rate the hardness of their erection via the single-item Likert scale EHS, at baseline and three months after the final injection. The scale is from 0-4. 0 is no erection, the higher the score the better erection.
Measured: From enrollment to 3 months post intervention.
Changes in the Major Depression Inventory (MDI)
The Major Depression Inventory (MDI) is a patient-reported outcome measure to assist with diagnosing and evaluation of the severity of a patient's depression.
The MDI score ranges from 0 to 50, where 0 represents no depression symptoms and 50 represents the most severe depression symptoms.
The participants will complete the MDI questionnaire at baseline and three months after the final injection.
The MDI is included due to previously described associations between Peyronie's disease and depression. The data may be used to assess the impact of disease progression on potential depressive symptoms.
Measured: From enrollment to 3 months post intervention.
The Ability to Engage in Sexual Intercourse (question)
The participants will be assessed at baseline and three months after the final injection regarding their ability to engage in sexual intercourse. This will be assessed by asking participants a single binary question: whether they are able to engage in sexual intercourse (yes or no).
Measured: From enrollment to 3 months post intervention.
Preference for Surgical Intervention (question)
The participants will be inquired about their preference for surgical intervention in relation to the current penile curvature at baseline and 3 months after the final injection. This will be assessed by asking participants a single binary question: whether they wish to undergo surgery given their current curvature (yes or no).
Measured: From enrollment to 3 months post intervention.
Satisfaction
The participants will complete a Global Assessment Scale Questionnaire regarding overall treatment satisfaction at the 3-month follow-up after the final injection.
The questionnaire consists of a single question regarding the participants' overall satisfaction with the treatment, to be answered on a scale from 1 to 5. A higher value indicates greater satisfaction.
Measured: From enrollment to 3 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 posted23 Jan 2025
- Study start10 Mar 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronies DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will receive six injections (three Platelet-Rich Plasma (PRP) and three saline), administered weekly in a randomized sequence. The RedCap randomization module ("Research Electronic Data Capture", a data management system used for research data) will ensure that each participant receives three injections of each type.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikael Heering, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789510
- Sponsor's protocol ID
- H-24019622-pilot
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Peyronie's Disease With Platelet-Rich Plasma: A Pilot Study
- ClinicalTrials.gov ID
- NCT06789510
- Acronym / sponsor ID
- H-24019622-pilot
- Conditions
- Peyronies Disease
- Keywords
- PRP, Platelet-Rich Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 23 Jan 2025 (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 pilot study is to optimize a planned randomized, double-blind, placebo-controlled clinical trial evaluating the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase. The pilot study aims to identify potential challenges in the practical execution of the clinical trial, particularly regarding PRP preparation and the blinding process. Furthermore, it seeks to evaluate the effects of PRP injections.
Detailed description
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. Subsequently, participants will attend weekly injection sessions for 6 weeks, during which they will receive 3 PRP injections and 3 saline injections (placebo) in a randomized order. Three months after the final injection, participants will attend a follow-up visit, where the final data will be collected. Analysis will then be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Each participant will receive six injections (three Platelet-Rich Plasma (PRP) and three saline), administered weekly in a randomized sequence. The RedCap randomization module ("Research Electronic Data Capture", a data management system used for research data) will ensure that each participant receives three injections of each type.
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma (PRP) | Experimental | Other: Autologous Platelet Rich PlasmaEach participant will receive 3 PRP injections over the 6-week period, with weekly injections in a randomized sequence. The RedCap randomization module will ensure that each participant receives 3 injections of each type. |
| Saline Solution (Placebo) | Placebo comparator | Other: Saline solutionEach participant will receive 3 saline injections over the 6-week period, with weekly injections in a randomized sequence. The RedCap randomization module will ensure that each participant receives 3 injections of each type. In addition, Platelet-Rich Plasma (PRP) will be prepared but, instead of being injected, it will be analyzed for platelet count. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Erectile Dysfunction unresponsive to on-demand PDE5 inhibitors
- Hourglass malformation
- Severely calcified plaques where injection is considered unfeasible
- History of priapism.
- History of penile fracture.
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 PlasmaAlso: PRP10 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. | Other | Platelet Rich Plasma (PRP) |
| Saline solutionAlso: Placebo10 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. | Other | Saline Solution (Placebo) |
Primary outcome
Platelet Concentration in the PRP
Time frame: The 6 week intervention period.
In the placebo sessions, the Platelet-Rich Plasma (PRP) sample (prepared using the Magellan Autologous Platelet Separator) will be sent for analysis of platelet concentration levels to ensure the quality of the PRP.
Evaluation of the Blinding Process
Time frame: The 6 week intervention period.
After each injection, both the administering physician and the participant will be asked to state whether they believe the injection contained PRP or saline. They will also be asked to justify their response, which will allow for adjustments to the practical implementation of the blinding process in the Randomized Controlled Trial (RCT), if necessary.
9 secondary outcomes
Adverse Events
Time frame: From the first injection to the 3 months post intervention follow-up.
Degree Changes in Penile Curvature.
Time frame: From enrollment to 3 months post intervention.
Changes in Plaque Size
Time frame: From enrollment to 3 months post intervention.
Changes in the Peyronie's Disease Questionnaire (PDQ)
Time frame: From enrollment to 3 months post intervention.
Changes in the Erection Hardness Score (EHS)
Time frame: From enrollment to 3 months post intervention.
Changes in the Major Depression Inventory (MDI)
Time frame: From enrollment to 3 months post intervention.
The Ability to Engage in Sexual Intercourse (question)
Time frame: From enrollment to 3 months post intervention.
Preference for Surgical Intervention (question)
Time frame: From enrollment to 3 months post intervention.
Satisfaction
Time frame: From enrollment to 3 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 22 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet Rich Plasma and Saline solution in people with Peyronies Disease, run by Herlev Hospital at 1 site in Denmark.
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 4 inclusion and 6 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 22 Sep 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Platelet Concentration in the PRP (time frame: The 6 week intervention period.). 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?
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 22 Sep 2026.