Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-Menopausal Women
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hormone Replacement Therapy, Post-Menopausal
Intervention: estradiol (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Liz Svensson, Study Director, Affiliation: Novo Nordisk Scandinavia AB
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).
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Time to first symptom of urinary tract infection (UTI)
Secondary outcome: Number of urinary tract infection (UTI)
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Malmo, Sweden
Additional Information
Clinical Trials at Novo Nordisk
Starting date: March 2003
Last updated: November 19, 2007
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