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)”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: estradiol

Primary Measures

• Time to first symptom of urinary tract infection (UTI)

Secondary Measures

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

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novo Nordisk

Overall Clinical Trial Officials and Contacts

Liz Svensson Study Director Novo Nordisk Scandinavia AB  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00560924

Study ID Number: VAG-1458

ClinicalTrials.gov Identifier: NCT00560924

Health Authority: Sweden: Medical Products Agency

Clinical Trials at Novo Nordisk