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

This study has been terminated.
(Trial prematurely discontinued due to slow recruitment)
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00560924
First received: November 19, 2007
Last updated: March 19, 2012
Last verified: March 2012

November 19, 2007
March 19, 2012
March 2003
March 2004   (final data collection date for primary outcome measure)
Time to first symptom of urinary tract infection (UTI) [ Designated as safety issue: No ]
Time to first symptom of urinary tract infection (UTI)
Complete list of historical versions of study NCT00560924 on ClinicalTrials.gov Archive Site
Number of urinary tract infection (UTI) [ Time Frame: During the 12 months of treatment ] [ Designated as safety issue: No ]
Number of urinary tract infection (UTI) [ Time Frame: during the 12 months of treatment ]
Not Provided
Not Provided
 
Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Menopause
  • Urinary Infections
Drug: estradiol, 25 mcg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
March 2004
March 2004   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00560924
VAG-1458
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Liz Svensson Novo Nordisk Scandinavia AB
Novo Nordisk A/S
March 2012

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