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NCT00560924 Clinical Trial

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

Menopause Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00560924
Other study ID # VAG-1458
Secondary ID
Status Terminated
Phase Phase 3
First received November 19, 2007
Last updated February 24, 2017
Start date March 21, 2003
Est. completion date March 17, 2004

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date March 17, 2004
Est. primary completion date March 17, 2004
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• estradiol, 25 mcg

Locations
Country Name City State
Sweden Novo Nordisk Investigational Site Malmö

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to first symptom of urinary tract infection (UTI)
Secondary Number of urinary tract infection (UTI) During the 12 months of treatment
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