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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00900653
First received: May 12, 2009
Last updated: May 29, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infections
 Drug: Gynoflor E (low dose estriol with lactobacillus)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Low Dose Estriol With Lactobacilli (Gynoflor) Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized, Open, Parallel-Group Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Incidence of urinary tract infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vaginal pH [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • lactobacillus colonization [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 142
Study Start Date: May 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Gynoflor E vaginal tablet
No Intervention: Control

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900653

Locations
Korea, Republic of
Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Jun Yong Choi, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT00900653     History of Changes
Other Study ID Numbers: 4-2009-0022
Study First Received: May 12, 2009
Last Updated: May 29, 2009
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
urinary tract infections
postmenopause
lactobacillus
estriol

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013