Low Dose Estriol With Lactobacilli Treatment for Preventi... | NCT00900653

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

NCT00900653

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Jun 1, 2009Estimated

Enrollment

142Estimated

Phase

Phase 4

Conditions

Urinary Tract Infections

Interventions

Gynoflor E (low dose estriol with lactobacillus)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

May 2010Estimated

Completion Date

Jul 2010Estimated

First Submitted Date

May 12, 2009

First Submission Date that Met QC Criteria

May 12, 2009

First Posted Date

May 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2009

Last Update Posted Date

Jun 1, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

142Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gynoflor	Experimental		Drug: Gynoflor E (low dose estriol with lactobacillus)
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gynoflor E (low dose estriol with lactobacillus)	Drug	The medication, in the form of one vaginal tablet, is administered in the evenings for 18 days	Gynoflor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of urinary tract infection		6 months

Secondary Outcomes

Measure	Description	Time Frame
vaginal pH		6 months
lactobacillus colonization		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University College of Medicine		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004964	Estriol
C100843	Lacteol

Ancestor Terms

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided