NCT00900653

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

June 1, 2009

Status Verified

May 1, 2009

Enrollment Period

1 year

First QC Date

May 12, 2009

Last Update Submit

May 29, 2009

Conditions

Urinary Tract Infections

Keywords

urinary tract infectionspostmenopauselactobacillusestriol

Outcome Measures

Primary Outcomes (1)

  • Incidence of urinary tract infection

    6 months

Secondary Outcomes (2)

  • vaginal pH

    6 months

  • lactobacillus colonization

    6 months

Study Arms (2)

Gynoflor

EXPERIMENTAL
Drug: Gynoflor E (low dose estriol with lactobacillus)

Control

NO INTERVENTION

Interventions

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

Also known as: Gynoflor E vaginal tablet
Gynoflor

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

EstriolLacteol

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 13, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2010

Study Completion

July 1, 2010

Last Updated

June 1, 2009

Record last verified: 2009-05

Locations

KR(1)