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OpenTrials
Completed

NCT Number: NCT02711943

Non Interventional Study of Levofloxacin in Chronic Prostatitis

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

About this study

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. Professional societies recommend diagnosing and treating patients with chronic prostatitis on the basis of determination of belonging to classification categories proposed by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institutes of Health in the USA .

According to the recommendations of European Association of Urologists, in chronic bacterial inflammation of the prostate and in nonbacterial (inflammatory syndrome of chronic pelvis pain), the performance of antibacterial therapy during four - six weeks is efficient. The first-line drugs are fluoroquinolones (ciprofloxacin and levofloxacin) as along with good tolerance they easily penetrate into the zones of the prostate inflammation and are highly efficient in respect of prostatitis pathogens . Although the treatment with levofloxacin promotes more evident decrease in clinical symptoms and demonstrates better parameters of eradication of pathogen in comparison with ciprofloxacin administration, it is used less common, possibly due to insufficient awareness of physicians of its high efficacy in chronic prostatitis .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Levofloxacin 500

Drug

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

Other names: Levolet R

Primary outcomes

  1. Percentage of patients with response as per IMPSS scale

    Time frame: 28 days

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

Secondary outcomes

  1. Percentage of patients response as per IMOS

    Time frame: 28 days

    Therapy results were evaluated using physician's opinion according to Integrative Medicine Outcome Scale - IMOS (complete recovery, significant improvement, insignificant to moderate improvement, no changes, deterioration)

Sponsors and collaborators

Lead sponsor

Dr. Reddy's Laboratories Limited

Industry

Registry information

Official study title

Non-interventional (Observational) Study of the Administration of Levolet® R, Film-coated Tablets (Dr. Reddy's Laboratories Ltd., India) in Adults With Chronic Prostatitis in Routine Clinical Practice

Acronym: Levolet-R

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2016
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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