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ISRCTN
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ISRCTN33778440
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DOI
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10.1186/ISRCTN33778440
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Evaluation of the efficacy of topical oestrogen therapy in the management of urinary dysfunction
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9410491
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Study hypothesis
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To evaluate the effect of topical oestrogen therapy on post-menopausal women with incontinence and bladder storage abnormality symptoms.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Incontinence
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Participants - inclusion criteria
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1. Urinary dysfunction measured clinically (incontinence, nocturia, frequent voiding, urinary urgency)
2. Post-menopausal women
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Participants - exclusion criteria
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1. Pregnancy
2. Malignancy
3. Fistula
4. Those already in receipt of treatment
5. Those already on hormone replacement therapy
6. Undiagnosed vaginal bleeding
7. Oestrogen dependent tumour
8. Active thrombo-embolic disease
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Anticipated start date
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01/09/1999
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Anticipated end date
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01/06/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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432
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Interventions
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1. Active: Topical vaginal oestrogen in the form of vaginal slow releasing rings (Estring)
2. Control: Matching placebo
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Primary outcome measure(s)
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Clinical assessment using urinary diaries and 24 hour home pad tests.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Contact name
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Dr
C
McGrother
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Address
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Department of Epidemiology and Public Health
University of Leicester
22-28 Princess Road West
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City/town
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Leicester
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Zip/Postcode
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LE1 2TP
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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20/07/2012
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Date ISRCTN assigned
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25/10/2000
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