Low Dose Estriol With Lactobacilli Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women

NCT ID: NCT00900653

Last Updated: 2009-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-07-31

Brief Summary

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Recurrent urinary tract infections (UTI) are a problem for postmenopausal women. The aim of this trial is to evaluate the effectiveness of lactobacilli in combination with low dose estriol for preventing recurrent urinary tract infections in postmenopausal women.

Detailed Description

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Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Gynoflor

Group Type EXPERIMENTAL

Gynoflor E (low dose estriol with lactobacillus)

Intervention Type DRUG

The medication, in the form of one vaginal tablet, is administered in the evenings for 18 days

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gynoflor E (low dose estriol with lactobacillus)

The medication, in the form of one vaginal tablet, is administered in the evenings for 18 days

Intervention Type DRUG

Other Intervention Names

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Gynoflor E vaginal tablet

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal woman
* History of urinary tract infection
* Agree to abstain from self-medication with antibiotics for UTI symptoms
* Agree to abstain from the use of any other intra-vaginal product
* Capable of providing informed consent

Exclusion Criteria

* Ovarian cancer, cervical cancer, breast cancer
* Estrogen treatment within last 2 years
* Vaginal bleeding
* Antibiotic therapy fewer than three days prior to randomization visit
* Known congenital urologic or gynecologic abnormalities
* Indwelling urinary catheter
* Thromboembolic disease
* Uncompensated liver disease
* Immunosuppressive drug within 60 days
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Yonsei University College of Medicine

Locations

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Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2009-0022

Identifier Type: -

Identifier Source: org_study_id

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