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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Yonsei University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00900653
First Posted: May 13, 2009
Last Update Posted: June 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Incidence of urinary tract infection [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • vaginal pH [ Time Frame: 6 months ]
  • lactobacillus colonization [ Time Frame: 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900653


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

Responsible Party: Jun Yong Choi, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT00900653     History of Changes
Other Study ID Numbers: 4-2009-0022
First Submitted: May 12, 2009
First Posted: May 13, 2009
Last Update Posted: June 1, 2009
Last Verified: May 2009

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases