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Effects of Proxelan Somministration in Patients With Chronic Prostatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03629769
Recruitment Status : Unknown
Verified August 2018 by Prof. Riccardo Bartoletti, University of Pisa.
Recruitment status was:  Recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Riccardo Bartoletti, University of Pisa

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.

Condition or disease Intervention/treatment Phase
Chronic Prostatitis Chronic Prostatitis With Chronic Pelvic Pain Syndrome Premature Ejaculation Drug: Proxelan Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Proxelan Somministration in Patients With Chronic Prostatitis Cat. IIa NIH: Pilot Study
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 30, 2018

Arm Intervention/treatment
Experimental: Patients with prostatitis-like symptoms
Cohort of patients with CP/CPPS (abacterial prostatitis)
Drug: Proxelan
Administration of one suppository of proxelan once a day for 30 days




Primary Outcome Measures :
  1. National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score [ Time Frame: 30 days ]
    Evaluation 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629769


Locations
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Italy
AOUP Ospedale cisanello Recruiting
Pisa, Toscana, Italy, 56124
Contact: Tommaso Di Vico, MD    3393642655    urologiapisa@gmail.com   
Sponsors and Collaborators
University of Pisa
Publications:
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Responsible Party: Prof. Riccardo Bartoletti, Professor, University of Pisa
ClinicalTrials.gov Identifier: NCT03629769    
Other Study ID Numbers: 1103 / 2016
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Riccardo Bartoletti, University of Pisa:
Prostate inflammation
CPS/CPPS
Prostatitis
Proxelan
Additional relevant MeSH terms:
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Prostatitis
Premature Ejaculation
Pelvic Pain
Chronic Disease
Pain
Neurologic Manifestations
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Disease Attributes
Pathologic Processes