Chronic prostatitis (with or without hyperplasia of the prostate)
Conditions
Interventions
Trade Name: Gynevac Lactobacillus vakcina
Product Name: Gynevac Lactobacillus vakcina
Pharmaceutical Form: Injection*
Current Sponsor code: Gynevac
Concentration unit: ml millilitre(s)
Concentration t
Sponsors
Vakcina Kft
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male patients of 25 to 75 years of age Symptoms of chronic prostatitis have been present fort a period not less than 6 months Positive result of the University of Washington Symptom Score (UWSS) (not less than 10 score values when answered the first 14 questions of the test) The patient is expected to collaborate and has signed the written informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Carcinoma of the prostate gland Relative contraindications to the use Gynevac lactobacillus vaccine (acute infections, immune deficiency states, etc) Hypersensitivity to ofloxacin or to the ingredients of Gynevac lactobacillus vaccine (formaldehyde, thiomersal) Drug dependence, alcoholism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the therapeutic effect of Gynevac lactobacillus vaccine in chronic prostatitis with that of the traditional antibiotic (ofloxacin) treatment;Secondary Objective: 1. To compare the safety of treatment with Gynevac lactobacillus vaccine with that of the traditional antibiotic (ofloxacin) treatment 2. To observe the effect of Gynevac lactobacillus vaccine on the symptoms of prostate hyperplasia;Primary end point(s): Changes in UWSS score values 1 week and 6 months after treatment (efficacy) Number and nature of possible intercurrent events and possible changes in laboratory values (safety) | — |
Countries
Hungary
Outcome results
None listed