Low Dose Estriol With Lactobacilli Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women
Phase 4
- Conditions
- Urinary Tract Infections
- Interventions
- Drug: Gynoflor E (low dose estriol with lactobacillus)
- Registration Number
- NCT00900653
- Lead Sponsor
- Yonsei University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 142
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gynoflor Gynoflor E (low dose estriol with lactobacillus) -
- Primary Outcome Measures
Name Time Method Incidence of urinary tract infection 6 months
- Secondary Outcome Measures
Name Time Method vaginal pH 6 months lactobacillus colonization 6 months
Trial Locations
- Locations (1)
Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of