Evaluation of the Efficacy and Safety of MV140
- Conditions
- rinary Tract infectionMedDRA version: 20.0Level: LLTClassification code 10038140Term: Recurrent urinary tract infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2013-001838-17-GB
- Lead Sponsor
- Syner-Med (PP) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 240
The individuals to be included in the study will meet the following criteria:
?Women who have given their informed consent. Age between 18 and 75 years.
?Must be able to meet the dosage regimen
?Individuals who have had at least 5 episodes of cystitis in the last 12 months.
?Individuals who have not responded to hygienic-sanitary measures and / or suppressive treatment and / or postcoital prophylaxis.
?Individuals who are free of urinary tract infections at the time of inclusion in the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Non- included individuals will be those who/whose:
?Have not given their informed consent.
?Age is not within the established age range.
?Cannot offer cooperation and/or have severe psychiatric disorders
?Present a pathologic post-micturition residue.
?Present moderate to severe incontinence
?Present genital tumors.
?Presents Urinary tract tumors.
?Present lithiasis
?Present alterations in the immune system
?Present complicated UTIs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method