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

Urinary Tract Infections Clinical Trial

Official title:

Low Dose Estriol With Lactobacilli (Gynoflor) Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized, Open, Parallel-Group Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00900653
• Other study ID #: 4-2009-0022
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: May 12, 2009
• Last updated: May 29, 2009
• Start date: May 2009
• Est. completion date: July 2010

Study information

• Verified date: May 2009
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 142
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of urinary tract infection		6 months	No
Secondary	vaginal pH		6 months	No
Secondary	lactobacillus colonization		6 months	No