Evaluation of the efficacy and safety of MV140

• Conditions: Recurrent Urinary Tract Infections; MedDRA version: 17.1Level: LLTClassification code 10038140Term: Recurrent urinary tract infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2013-001838-17-ES
• Lead Sponsor: Inmunotek, S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-16
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Gave written informed consent.
-Women
-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
F.1.3.1 Number of subjects for this age range 240

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To obtain the prevention of recurrent urinary tract infections in women immunized with the bacterial vaccine after a treatment of three or six months, compared with the placebo group.;Secondary Objective: -To compare the rate of episodes in the study time among groups of treatment compared with placebo.<br>-Compare by a reason cost-benefit the three treatment groups.<br>-Time elapsed from the beginning of treatment until the appearance of the first ITU.<br>-Use of antibiotics as a prophylaxis and treatment of infections.;Primary end point(s): Average of diagnosed or symptomatic episodes of UTIs in study time.;Timepoint(s) of evaluation of this end point: At the beginning and after the treatment of 3 or 6 months.