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Effects of Proxelan Somministration in Patients With Chronic Prostatitis

Effects of Proxelan Somministration in Patients With Chronic Prostatitis Cat. IIa NIH: Pilot Study

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03629769
Enrollment
30
Registered
2018-08-14
Start date
2017-02-16
Completion date
2018-09-30
Last updated
2018-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Premature Ejaculation

Keywords

Prostate inflammation, CPS/CPPS, Prostatitis, Proxelan

Brief summary

The purpose of the study is to determinate the antinflammatory effects of the Proxelan on a cohort of patients affected by prostatitis'like symptoms and clinical evidence of abacterical prostatistis, trough a significative improvements of pain symptoms according to the NIH-CPSI questionnaire items, spermatozoa motility/concentration variations and the semen cytokines level decrease.

Interventions

DRUGProxelan

Administration of one suppository of proxelan once a day for 30 days

Sponsors

University of Pisa
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

\- prostatitis like symptoms for at least three months

Exclusion criteria

* significant post-voidal residual volume * Meares and Stamey test suggestive for bacterial infection * neoplasms, * urinary stones, * antibiotic therapy in the previous three months, * irritable bowel syndrome, * previous radiotherapic or chemiotherapic treatment, * urethral stenosis, * neurogenic bladder * previous prostatic surgery

Design outcomes

Primary

MeasureTime frameDescription
National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score30 daysEvaluation of pain symptoms trough NIH-CPS questionnaires' pain items (0-6). Values from 0 to 3 normal/slight symptoms; Values from 3 to 6 moderate symptoms; Values over 6 severe symptoms.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026