Effects of Proxelan Somministration in Patients With Chronic Prostatitis

NCT ID: NCT03629769

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-16

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Prostatitis Chronic Prostatitis With Chronic Pelvic Pain Syndrome Premature Ejaculation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with prostatitis-like symptoms

Cohort of patients with CP/CPPS (abacterial prostatitis)

Group Type EXPERIMENTAL

Proxelan

Intervention Type DRUG

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

Interventions

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Proxelan

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Prof. Riccardo Bartoletti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AOUP Ospedale cisanello

Pisa, Tuscany, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Tommaso Di Vico, MD

Role: primary

3393642655

References

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Galeone G, Spadavecchia R, Balducci MT, Pagliarulo V. [The role of Proxelan in the treatment of chronic prostatitis. Results of a randomized trial]. Minerva Urol Nefrol. 2012 Jun;64(2):135-41. Italian.

Reference Type BACKGROUND
PMID: 22617307 (View on PubMed)

Other Identifiers

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1103 / 2016

Identifier Type: -

Identifier Source: org_study_id

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