A Phase 4 interventional study of FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium in Chronic Prostatitis (CP), Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Chronic Prostatitis/ Pelvic Pain Syndrome, sponsored by Clinica Urologica Molinette - Città della Saliute e della Scienza. Completed at 2 sites in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Clinica Urologica Molinette - Città della Saliute e della Scienza · Phase 4, Interventional, and Treatment
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a bothering condition characterized by pain localized to the pelvic, perineal and/or genital area and lower urinary tract symptoms (LUTS). Phytotherapy, which involves the combination of two or more active compounds, can be used to treat this challenging condition.
The aim of this study was to investigate the role of an association of phycocyanin (PC) and palmitoylethanolamide (PEA) and selenium (FICOXPEA®) in male patients affected by CP/CPPS.
The main questions the present study aims to answer are:
Researchers will investigate whether FICOXPEA® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy.
Participants will:
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 48 is below the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →Clinica Urologica Molinette - Città della Saliute e della Scienza is the lead sponsor of 2 studies on the registry; none are open to participants now.
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A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FICOXPEA® is a phytoterapic compound made of: * phycocyanin (spirulina platensis extract) 250 mg * palmitoylethanolamide 200 mg * L-selenometionine 11 mg 1. capsule containing all these compounds is administered every day for 30 days
Drug: FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium
FICOXPEA® is a phytoterapic compound made of: * phycocyanin (spirulina platensis extract) 250 mg * palmitoylethanolamide 200 mg * L-selenometionine 11 mg
Statistically significant change of CPSI total score compared to baseline
Improvement of CP symptoms
Time frame: 1 month and 3 months
Statistically significant change of CPSI pain domain score compared to baseline
improvement of CP pain symptoms
Time frame: 1 month and 3 months
Statistically significant change of CPSI QoL domain score compared to baseline
Improvement of CP QoL
Time frame: 1 month and 3 months
Statistically significant change of total PSA
Decrease of chronic altered PSA values
Time frame: 1 month and 3 months
n° of any adverse events
number and type, so safety analysis
Time frame: 1 month and 3 months
Plan to share: No
Ran from Nov 2022 to primary completion in Aug 2023, 9 months.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Clinica Urologica Molinette - Città della Saliute e della Scienza