Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9410491
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the effect of topical oestrogen therapy on post-menopausal women with incontinence and bladder storage abnormality symptoms.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Incontinence
Intervention
1. Active: Topical vaginal oestrogen in the form of vaginal slow releasing rings (Estring)
2. Control: Matching placebo
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Clinical assessment using urinary diaries and 24 hour home pad tests.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1999
Overall trial end date
01/06/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Urinary dysfunction measured clinically (incontinence, nocturia, frequent voiding, urinary urgency)
2. Post-menopausal women
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
432
Participant exclusion criteria
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
Recruitment start date
01/09/1999
Recruitment end date
01/06/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Epidemiology and Public Health
Leicester
LE1 2TP
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary