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 )

First Received on November 19, 2007. Last Updated on November 18, 2011 History of Changes

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00560924

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
Hormone Replacement Therapy, Post-Menopausal	Drug: estradiol, 25 mcg	Phase III

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:

MedlinePlus related topics: Hormone Replacement Therapy Menopause Urinary Tract Infections

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

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:	November 18, 2011
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 February 09, 2012