NCT07013890

Efficacy of Phycocyanin and Palmitoylethanolamide for the Treatment of Chronic Prostatitis Symptoms

Completed Phase 4 Last updated 24 July 2025

What this trial tests

Phase 4 trial testing FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium in Chronic Prostatitis (CP) in 48 participants. Completed in 30 September 2023.

Timeline

2 November 2022

Primary endpoint
15 August 2023

30 September 2023

Quick facts

Lead sponsor	Clinica Urologica Molinette - Città della Saliute e della Scienza
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	2 November 2022
Primary completion	15 August 2023
Estimated completion	30 September 2023
Sites	2 locations across Italy

Drugs / interventions tested

• FICOXPEA® is an oral combination of Phycocyanin, Palmitoylethanolamide and selenium — full drug profile →

Conditions studied

• Chronic Prostatitis (CP) — all drugs for Chronic Prostatitis (CP) →
• Chronic Prostatitis With Chronic Pelvic Pain Syndrome — all drugs for Chronic Prostatitis With Chronic Pelvic Pain Syndrome →
• Chronic Prostatitis/ Pelvic Pain Syndrome — all drugs for Chronic Prostatitis/ Pelvic Pain Syndrome →

Sponsor

Clinica Urologica Molinette - Città della Saliute e della Scienza

Who can join

18 and older, male only, with Chronic Prostatitis (CP) or Chronic Prostatitis With Chronic Pelvic Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

* Does FICOXPEA® enhance quality of life of CPP/CPPS patients?
* Does it help reducing pain symptoms of CPP/CPPS patients?

Researchers will investigate whether FICOXPEA® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy.

Participants will:

* Take FICOXPEA® once a day for 30 days;
* Visit the clinic for follow-up visits at 1 and 3 months;
* Answer validated questionnaires and declare potential adverse events at follow-up visits.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.