EUCTR2013-001838-17-ES
Active, not recruiting
Not Applicable
PROSPECTIVE MULTICENTER CLINICAL TRIAL RANDOMIZED, DOUBLE-BLIND, PARALLEL-CONTROLLED VERSUS PLACEBO IN A POLYVALENT SUBLINGUAL BACTERIAL VACCINE (IN ORAL MUCOSA) TO THREE MONTHS AND SIX MONTHS IN WOMEN WITH RECURRENT URINARY TRACT INFECTIONS FOR THE IMMUNOMODULATORY EFFICACY EVALUATION, SAFETY AND CLINICAL IMPACT
Inmunotek, S.L.0 sitesFebruary 16, 2015
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recurrent Urinary Tract Infections
- Sponsor
- Inmunotek, S.L.
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Gave written informed consent.
- •\-Aged between 18 and 75 years.
- •\-They must be able to meet the dosing regimen.
- •\-Individuals who have had at least 3 episodes of cystitis in the past 12 months.
- •\-Subject that does not have responded to health and hygiene measures and/or suppressive treatments and/or postcoital prophylaxis.
- •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 240
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •\-Not have granted the informed written consent.
- •\-Not included in the established age range.
- •\-Not to offer cooperation I have serious psychiatric disorders.
- •\-Present pathological post\-voiding residue.
- •\-Submit moderada\-grave incontinence.
- •\-Present genital tumors.
- •\-Suffering from urinary tract tumors.
- •\-Submit lithiasis.
- •\-Present alterations in the immune system.
Outcomes
Primary Outcomes
Not specified
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