Finding studies
Finding studies
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Lead
Elexial Research Limited
With
The goal of this clinical trial is to evaluate the effectiveness of intracavernosal autologous platelet-rich plasma therapy, compared with placebo, for the treatment of moderate or mild to moderate erectile dysfunction, measured as improvement in the IIEF-EF questionnaire score. Study design: Randomized, double-blind, placebo-controlled clinical trial, phase III. The study will include four groups: * G1 - Autologous PRP: Autologous Platelet Rich Plasma (PRP) + placebo shock waves * G2 - combined therapy: Autologous PRP + focal shock waves * G3 - placebo control: Placebo PRP + placebo shock waves * G4 - shock waves: PRP placebo + shock waves 116 subjects will be included, who will be randomized in a 1:1:1:1 ratio in the four groups described above. The change in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) score, the change in the Erection Hardness Score (EHS), and the adverse events will be evaluated at the end of treatment, and 1, 3, and 6 months of follow-up.
Age
18–any
Sex
MALE
Healthy volunteers
Accepted
