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

May 29, 2009 updated by: Yonsei University

Low Dose Estriol With Lactobacilli (Gynoflor) Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized, Open, Parallel-Group Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Gynoflor
Drug: Gynoflor E (low dose estriol with lactobacillus)
The medication, in the form of one vaginal tablet, is administered in the evenings for 18 days
Other Names:
  • Gynoflor E vaginal tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of urinary tract infection
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
vaginal pH
Time Frame: 6 months
6 months
lactobacillus colonization
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

May 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 13, 2009

Study Record Updates

Last Update Posted (Estimate)

June 1, 2009

Last Update Submitted That Met QC Criteria

May 29, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2009-0022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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