Azienda Ospedaliero Universitaria Careggi, University Of Florence
Sponsor type
Hospital/Clinic/Other health care facility, Educational Institution
Therapeutic area
Male Urogenital Diseases
Decision date
23/06/2026
Enrollment target
410
Sites
Italy
Condition studied
Benign prostatic hypertrophy
Investigational medicinal product(s)
PERMIXON 160 mggélulePlacebo matching Macrogol 6000. Non-authorised productmanufactured specifically for this clinical trial by Pierre Fabre Medicament Production (MIA No. 2025 247 1 2) and packaged/labelled/batch released by Creapharm (MIA No. 2025 001 1 2 4 10). One hard capsule contains only 350 mg Macrogol 6000. No active substance. EU MP number: not applicable. Marketing Authorisation: not applicable.
Eligibility
Age group
18-64 years, 65+ years
Sex
Male
Primary endpoint
Proportion of patients undergoing a repeat prostate biopsy within 12 months
Endpoint detail
ln[PSA] value measured at 12 months, PINS score at 12 months, PIRADS score at 12 months, Number of lesions at 12 months, IS and IRANI score at 12 months, IPSS and IIEF-5 at 12 months, Proportion of patients diagnosed with prostate cancer within 12 months
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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