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Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menopause; Urinary Infections

Intervention: estradiol, 25 mcg (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Novo Nordisk A/S

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Malmö 205 02, Sweden
Additional Information

Clinical Trials at Novo Nordisk

Starting date: March 2003
Last updated: March 19, 2012

Page last updated: August 23, 2015

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