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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)
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: November 19, 2007
Last updated: February 24, 2017
Last verified: February 2017
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
Urinary Infections
Drug: estradiol, 25 mcg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, 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:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Time to first symptom of urinary tract infection (UTI)

Secondary Outcome Measures:
  • Number of urinary tract infection (UTI) [ Time Frame: During the 12 months of treatment ]

Enrollment: 6
Actual Study Start Date: March 21, 2003
Study Completion Date: March 17, 2004
Primary Completion Date: March 17, 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00560924

Novo Nordisk Investigational Site
Malmö, Sweden, 205 02
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00560924     History of Changes
Other Study ID Numbers: VAG-1458
Study First Received: November 19, 2007
Last Updated: February 24, 2017

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female processed this record on May 25, 2017