Platelet-rich Plasma (PRP) Injection for Treatment of Erectile Function
NCT04050020 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2020-10-20
Summary
The primary objective of the present study is to investigate and compare the treatment efficacy of PRP injection vs placebo treatment in men with mild-moderate vasculogenic ED, as measured by IIEF.The secondary objective of the present clinical trial is to study the adverse events and safety of the PRP injection treatment in vasculogenic ED patients
Conditions
- Erectile Dysfunction Due to Arterial Insufficiency
Interventions
- BIOLOGICAL
-
Platelet-Rich Plasma (PRP)
All subjects of this group will receive 2 sessions of PRP penile injection with 30 +/- 3 day treatment interval, 10 ml of PRP will be injected at each session.
- BIOLOGICAL
-
Normal saline injection
All subjects of this group will receive 2 sessions of normal saline penile injection with 30 +/- 3 day treatment interval for all subjects, 10 ml of normal saline will be injected at each session.
Sponsors & Collaborators
-
European Society for Sexual Medicine
collaborator UNKNOWN -
Institute for the Study of Urological Diseases, Greece
lead OTHER
Principal Investigators
-
Dimitrios Hatzichristou, Prof. · G.Gennimatas General Hospital, Thessaloniki,Greece
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-02
- Primary Completion
- 2020-03-26
- Completion
- 2020-09-24
Countries
- Greece
Study Locations
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