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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Urinary Tract Infections

Treatments: Drug: Gynoflor E (low dose estriol with lactobacillus)

Study type: Interventional

Funder types: Other

Identifiers

NCT00900653

4-2009-0022

Details and patient eligibility

About

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.

Enrollment: 142 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Gynoflor

Experimental group

Treatment:

Drug: Gynoflor E (low dose estriol with lactobacillus)

Control

No Intervention group