Peyronies DiseaseNCT07117955
Platelet-Rich Plasma for Peyronie's Disease
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 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. 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
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Oct 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clearly palpable penile plaque
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte University Hospital
Herlev, 2100
Mette L.K. Schmidt, Ph.d., +4538681100, mette.ladefoged.kopp.schmidt@regionh.dk
About this study
Official title: Treatment of Peyronie's Disease With Platelet-Rich Plasma: A Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
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. 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
- Peyronies Disease
- Being tested
- Autologous Platelet Rich Plasma, Saline solution
- Keywords
- Andrology, Platelet-Rich Plasma, Penile induration, PRP
- 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
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 solutionOther
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma (PRP) | Experimental | Not described Receives: Other: Autologous Platelet Rich Plasma |
| Saline Solution (Placebo) | Placebo comparator | Not described Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 12 months post intervention.
Secondary outcomes (7)
Changes in Plaque Size
Plaque size will be measured at baseline and 3, 6 and 12 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 12 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 3, 6 and 12 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 3, 6 and 12 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 12 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 3, 6 and 12 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 12 months post intervention.
The Ability to Engage in Sexual Intercourse (question)
The participants will be assessed at baseline and 3, 6 and 12 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 12 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, 6 and 12 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 12 months post intervention.
Changes in Global Assessment Scale Questionnaire
The participants will complete a Global Assessment Scale Questionnaire regarding overall treatment satisfaction at the 3-, 6- and 12 months 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 3 to 12 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 posted12 Aug 2025
- Study start21 Oct 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikael Heering, Herlev and Gentofte Hospital
- Investigators
- Mikkel M. Fode, Professor, MD, Ph.d., Principal investigator, Herlev and Gentofte University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117955
- Sponsor's protocol ID
- H-24019622
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 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 Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07117955
- Acronym / sponsor ID
- H-24019622
- Conditions
- Peyronies Disease
- Keywords
- Andrology, Platelet-Rich Plasma, Penile induration, PRP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 12 Aug 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 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.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma (PRP) | Experimental | Other: Autologous Platelet Rich Plasma |
| Saline Solution (Placebo) | Placebo comparator | Other: Saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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
- Clearly palpable penile plaque
Key exclusion criteria (8 listed)
- Erectile Dysfunction unresponsive to on-demand PDE5 inhibitors
- Hourglass malformation
- Severely calcified plaques where injection is considered unfeasible
- Intrapenile plaque
- History of priapism.
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: PRP6 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: Placebo6 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
Degree Changes in Penile Curvature.
Time frame: From enrollment to 12 months post intervention.
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.
7 secondary outcomes
Changes in Plaque Size
Time frame: From enrollment to 12 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 12 months post intervention.
Changes in the Major Depression Inventory (MDI)
Time frame: From enrollment to 12 months post intervention.
The Ability to Engage in Sexual Intercourse (question)
Time frame: From enrollment to 12 months post intervention.
Preference for Surgical Intervention (question)
Time frame: From enrollment to 12 months post intervention.
Changes in Global Assessment Scale Questionnaire
Time frame: From 3 to 12 months post intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
Mikkel M. Fode, Professor, MD, Ph.d. principal investigator
Herlev and Gentofte University Hospital
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 5 inclusion and 8 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikael Heering, MD, Ph.d. student (+4538688964, mikael.heering@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree Changes in Penile Curvature. (time frame: From enrollment to 12 months post intervention.). 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.