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

May 12, 2009
May 29, 2009
May 2009
May 2010   (final data collection date for primary outcome measure)
Incidence of urinary tract infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00900653 on ClinicalTrials.gov Archive Site
  • vaginal pH [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • lactobacillus colonization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Low Dose Estriol With Lactobacilli Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women
Low Dose Estriol With Lactobacilli (Gynoflor) Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized, Open, Parallel-Group Study

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Urinary Tract Infections
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
  • Experimental: Gynoflor
    Intervention: Drug: Gynoflor E (low dose estriol with lactobacillus)
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
142
July 2010
May 2010   (final data collection date for primary outcome measure)

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
Female
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00900653
4-2009-0022
No
Jun Yong Choi, Yonsei University College of Medicine
Yonsei University
Not Provided
Not Provided
Yonsei University
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP