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

Tracking Information
First Received Date ^ICMJE	May 12, 2009
Last Updated Date	May 29, 2009
Start Date ^ICMJE	May 2009
Estimated Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 12, 2009)	Incidence of urinary tract infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00900653 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 12, 2009)	vaginal pH [ Time Frame: 6 months ] [ Designated as safety issue: No ] lactobacillus colonization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Low Dose Estriol With Lactobacilli Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women
Official Title ^ICMJE	Low Dose Estriol With Lactobacilli (Gynoflor) Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized, Open, Parallel-Group Study
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Urinary Tract Infections
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Gynoflor Intervention: Drug: Gynoflor E (low dose estriol with lactobacillus) No Intervention: Control
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	142
Estimated Completion Date	July 2010
Estimated Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT00900653
Other Study ID Numbers ^ICMJE	4-2009-0022
Has Data Monitoring Committee	No
Responsible Party	Jun Yong Choi, Yonsei University College of Medicine
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top