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

Phase 3

Terminated

• Conditions: Urinary Infections; Menopause

• Registration Number: NCT00560924
• Lead Sponsor: Novo Nordisk A/S

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

Not available

Study Timeline

• Study Start: 2003-03-21
• Primary Completion: 2004-03-17
• Study Completion: 2004-03-17
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to first symptom of urinary tract infection (UTI)

Secondary Outcome Measures

Name	Time	Method
Number of urinary tract infection (UTI)	During the 12 months of treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Malmö, Sweden