Back to resultsPreventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women
Primary Purpose
Menopause, Urinary Infections
Status
Terminated
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
estradiol, 25 mcg
Sponsored by
About this trial
This is an interventional treatment trial for Menopause
Eligibility Criteria
Inclusion Criteria:
- Post-menopausal woman with Urogenital ageing (UGA)
- Recurrent urinary tract infections defined as three or more urinary tract infections within the past twelve months
Exclusion Criteria:
- Known or suspected allergy to trial product or related products
- Present UTI
- History of RUTI during fertile period of life
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Time to first symptom of urinary tract infection (UTI)
Secondary Outcome Measures
Number of urinary tract infection (UTI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00560924
Brief Title
Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women
Official Title
Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women (RUTI) in Post-menopausal Women With Signs of Urogenital Ageing (UGA)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Trial prematurely discontinued due to slow recruitment
Study Start Date
March 21, 2003 (Actual)
Primary Completion Date
March 17, 2004 (Actual)
Study Completion Date
March 17, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the preventive effect of treatment with estradiol vaginal tablets on recurrent urinary tract infections (RUTI) in post-menopausal women with signs of urogenital ageing (UGA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Urinary Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
estradiol, 25 mcg
Primary Outcome Measure Information:
Title
Time to first symptom of urinary tract infection (UTI)
Secondary Outcome Measure Information:
Title
Number of urinary tract infection (UTI)
Time Frame
During the 12 months of treatment
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-menopausal woman with Urogenital ageing (UGA)
Recurrent urinary tract infections defined as three or more urinary tract infections within the past twelve months
Exclusion Criteria:
Known or suspected allergy to trial product or related products
Present UTI
History of RUTI during fertile period of life
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women
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