Condition category
Urological and Genital Diseases
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
20/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr C McGrother

ORCID ID

Contact details

Department of Epidemiology and Public Health
University of Leicester
22-28 Princess Road West
Leicester
LE1 2TP
United Kingdom

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Publication citations

Additional files

Editorial Notes