Urinary Tract InfectionsPhase 4NCT00900653
Low Dose Estriol With Lactobacilli Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women
A Phase 4 study testing Gynoflor E (low dose estriol with lactobacillus) in people with Urinary Tract Infections, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Gynoflor E (low dose estriol with lactobacillus)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Thromboembolic disease
- Uncompensated liver disease
- Immunosuppressive drug within 60 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Gynoflor E (low dose estriol with lactobacillus)
- Keywords
- urinary tract infections, postmenopause, lactobacillus, estriol
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynoflor E (low dose estriol with lactobacillus)Drug
Also called Gynoflor E vaginal tablet
The medication, in the form of one vaginal tablet, is administered in the evenings for 18 days
| Study group | Role | What they receive |
|---|---|---|
| Gynoflor | Experimental | Not described Receives: Drug: Gynoflor E (low dose estriol with lactobacillus) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urinary tract infection
Measured: 6 months
Secondary outcomes (2)
vaginal pH
Measured: 6 months
lactobacillus colonization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900653
- Sponsor's protocol ID
- 4-2009-0022
- Status last verified
- May 2009
- First submitted
- 12 May 2009
- Last updated
- 1 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Estriol With Lactobacilli (Gynoflor) Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized, Open, Parallel-Group Study
- ClinicalTrials.gov ID
- NCT00900653
- Acronym / sponsor ID
- 4-2009-0022
- Conditions
- Urinary Tract Infections
- Keywords
- urinary tract infections, postmenopause, lactobacillus, estriol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gynoflor | Experimental | Drug: Gynoflor E (low dose estriol with lactobacillus) |
| Control | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gynoflor E (low dose estriol with lactobacillus)Also: Gynoflor E vaginal tabletThe medication, in the form of one vaginal tablet, is administered in the evenings for 18 days | Drug | Gynoflor |
Primary outcome
Incidence of urinary tract infection
Time frame: 6 months
2 secondary outcomes
vaginal pH
Time frame: 6 months
lactobacillus colonization
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gynoflor E (low dose estriol with lactobacillus) in people with Urinary Tract Infections, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of urinary tract infection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2009.