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

Tracking Information

First Received Date ^ICMJE

November 19, 2007

Last Updated Date

June 12, 2009

Start Date ^ICMJE

March 2003

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to first symptom of urinary tract infection (UTI) [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Time to first symptom of urinary tract infection (UTI)

Change History

Complete list of historical versions of study NCT00560924 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of urinary tract infection (UTI) [ Time Frame: during the 12 months of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Number of urinary tract infection (UTI) [ Time Frame: during the 12 months of treatment ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hormone Replacement Therapy, Post-Menopausal

Intervention ^ICMJE

Drug: estradiol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

March 2004

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00560924

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

VAG-1458

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Liz Svensson

Novo Nordisk Scandinavia AB

Information Provided By

Novo Nordisk

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP