EUCTR2004-004003-38-HUActive, not recruitingNot Applicable
Kettos vak, randomizalt komparativ vizsgalat a Gynevac lactobacillus vakcinaval vegzett kezeles hatekonysaganak es biztonsaganak osszehasonlitasara a hagyomanyos antibiotikus (ofloxacin) kezelessel chronikus prostatitsben szenvedo betegek koreben - GYNEVAC/PROSTATIS
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Vakcina Kft
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
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
- •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
Investigators
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