NCT02711943

Brief Summary

Chronic prostatitis is a common disease in men with the following typical symptoms decreasing the ability to work and quality of life: pain, urination disorders, copulatory dysfunction. Following study is conducted to study Levofloxacin in chronic prostatitis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

March 14, 2016

Last Update Submit

March 16, 2016

Conditions

Chronic Prostatitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with response as per IMPSS scale

    Subjective evaluation of the treatment was performed using Integrative Medicine Patient Satisfaction Scale - IMPSS: completely satisfied, satisfied, neutral attitude, unsatisfied and extremely unsatisfied.

    28 days

Secondary Outcomes (1)

  • Percentage of patients response as per IMOS

    28 days

Interventions

Levofloxacin 500DRUG

Oral levofloxacin (Levolet®) at a dose of 500 mg once a day for 28 days

Also known as: Levolet R

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic prostatitis, age 18-60 years

You may qualify if:

  • male patients aged from 18 to 60 years, inclusive, with a diagnosis of the chronic prostatitis, which appointed the drug Levolet® P as a causal treatment.
  • Demonstrated sensitivity to levofloxacin abjection of chronic bacterial prostatitis.
  • The presence of a written informed consent to participate in research

You may not qualify if:

  • participation in another clinical study during the period of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • IGOR A KORNEYEV

    Acad. I.P. Pavlov First Saint-Petersburg State Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 17, 2016

Study Start

July 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

March 17, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share