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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
ClinicalTrials.gov Identifier:
NCT00560924
First received: November 19, 2007
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Menopause
Urinary Infections
 Drug: estradiol, 25 mcg
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

Secondary Outcome Measures:
  • Number of urinary tract infection (UTI) [ Time Frame: During the 12 months of treatment ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: March 2003
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560924

Locations
Sweden
Malmö, Sweden, 205 02
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Liz Svensson Novo Nordisk Scandinavia AB
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00560924     History of Changes
Other Study ID Numbers: VAG-1458
Study First Received: November 19, 2007
Last Updated: March 19, 2012
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 23, 2013