Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2021-03-29
2025-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Experimental: Autologous PRP followed by Placebo Group
Participants in this group will receive the autologous intervention first, followed by the placebo intervention 3 months later.
Autologous Platelet Rich Plasma
2 sessions of Autologous PRP will be administered 15 days apart. Each injection will be 0.5 mL of PRP injected into the Peyronie's disease penile plaque.
Saline Solution
2 sessions of saline injection will be administered 15 days apart. Each injection will be 0.5 mL of normal saline injected into the Peyronie's disease penile plaque.
Experimental: Placebo followed by Autologous PRP Group
Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 3 months later.
Autologous Platelet Rich Plasma
2 sessions of Autologous PRP will be administered 15 days apart. Each injection will be 0.5 mL of PRP injected into the Peyronie's disease penile plaque.
Saline Solution
2 sessions of saline injection will be administered 15 days apart. Each injection will be 0.5 mL of normal saline injected into the Peyronie's disease penile plaque.
Interventions
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Autologous Platelet Rich Plasma
2 sessions of Autologous PRP will be administered 15 days apart. Each injection will be 0.5 mL of PRP injected into the Peyronie's disease penile plaque.
Saline Solution
2 sessions of saline injection will be administered 15 days apart. Each injection will be 0.5 mL of normal saline injected into the Peyronie's disease penile plaque.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Be 18 to 75 years of age (inclusive).
3. Be able to provide written informed consent
4. Have a diagnosis of PD with evidence of active or stable disease as determined by the investigator
5. Penile curvature deformity of \>30° to \<120°
6. Agree to comply with all study related tests/procedures.
Exclusion Criteria
2. Previous intralesional injection therapy (such as Xiaflex) for PD.
3. Previous history of priapism or penile fracture
4. PD characterized by a ventral plaque
5. Severe erectile dysfunction as characterized with an International Index of Erectile Function (IIEF) score ≤ 16
6. Actively on anticoagulation during time frame of injections (aspirin 81 mg will be eligible for therapy)
7. Hour-glass deformity
8. Unwilling to participate
9. Medically unfit for sexual intercourse as deemed by the principal investigator
10. Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
11. 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.
18 Years
75 Years
MALE
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Manuel Molina Leyba
Research Physician
Principal Investigators
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Manuel Molina, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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References
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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.
Other Identifiers
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20200779
Identifier Type: -
Identifier Source: org_study_id
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