Back to resultsLow Dose Estriol With Lactobacilli Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women
Primary Purpose
Urinary Tract Infections
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gynoflor E (low dose estriol with lactobacillus)
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infections focused on measuring urinary tract infections, postmenopause, lactobacillus, estriol
Eligibility Criteria
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
Sites / Locations
- Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Gynoflor
Control
Arm Description
Outcomes
Primary Outcome Measures
Incidence of urinary tract infection
Secondary Outcome Measures
vaginal pH
lactobacillus colonization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00900653
Brief Title
Low Dose Estriol With Lactobacilli Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women
Official Title
Low Dose Estriol With Lactobacilli (Gynoflor) Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized, Open, Parallel-Group Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
urinary tract infections, postmenopause, lactobacillus, estriol
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gynoflor
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Gynoflor E (low dose estriol with lactobacillus)
Other Intervention Name(s)
Gynoflor E vaginal tablet
Intervention Description
The medication, in the form of one vaginal tablet, is administered in the evenings for 18 days
Primary Outcome Measure Information:
Title
Incidence of urinary tract infection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
vaginal pH
Time Frame
6 months
Title
lactobacillus colonization
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Low Dose Estriol With Lactobacilli Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women
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