An interventional study of Autologous Platelet Rich Plasma and Saline solution in Peyronies Disease, sponsored by Herlev Hospital. Recruiting at 1 site in Denmark. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Herlev Hospital · Not applicable, Interventional, and Treatment
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.
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.
47 studies on the registry are indexed under Penile Induration; 10 are open to participants now.
This study's planned enrollment of 84 is above the median of 40 across 39 interventional studies indexed under Penile Induration.
Browse Penile Induration studies →Herlev Hospital is the lead sponsor of 201 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Other: Autologous Platelet Rich Plasma
Other: Saline solution
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.
Also known as: PRP
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.
Also known as: Placebo
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.
Time frame: From enrollment to 12 months post intervention.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: From 3 to 12 months post intervention.
Plan to share: No
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