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Clinical Trials/EUCTR2013-001838-17-ES
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.

Registry
who.int
Start Date
February 16, 2015
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Inmunotek, S.L.

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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