|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00900653 |
|
Date of registration:
|
12/05/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Low Dose Estriol With Lactobacilli Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women
|
|
Scientific title:
|
Low Dose Estriol With Lactobacilli (Gynoflor) Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized, Open, Parallel-Group Study |
|
Date of first enrolment:
|
May 2009 |
|
Target sample size:
|
142 |
|
Recruitment status: |
Enrolling by invitation |
|
URL:
|
http://clinicaltrials.gov/show/NCT00900653 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Key inclusion & exclusion 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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Urinary Tract Infections
|
|
Intervention(s)
|
|
Drug: Gynoflor E (low dose estriol with lactobacillus)
|
|
Primary Outcome(s)
|
|
Incidence of urinary tract infection
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
vaginal pH
[Time Frame: 6 months]
|
|
lactobacillus colonization
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
4-2009-0022
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|