A pilot study to examine the efficacy of vaginally administered oestradiol in the treatment of faecal incontinence in post menopausal wome
Phase 1
- Conditions
- Faecal Incontinence
- Registration Number
- EUCTR2005-001975-37-GB
- Lead Sponsor
- orth West London NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 43
Inclusion Criteria
Women who have developed faecal incontinence 2 years post menopause and who are not using HRT or used it in the previous two years, including local vaginal therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Diabetes Mellitus
Neurological disorder
Terminal illness
Currently receiving treatment for carcinoma of the breast.
Detainment under the Mental Health Act (1983)
Dementia/organic brain disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this pilot study is to establish whether vaginall administered oestrogen provides an improvement in symptoms for post menopausal women with faecal incontinence. If any improvement in their symptoms is seen further investigation will be justified.;Secondary Objective: To check systemic absorption of Vagifem, through blood assay oestradiol levels.<br><br>To ensure safety of the endometrium during administration.;Primary end point(s): Incidence of faecal incontinence symtpoms after treatment, based on bowel symptoms questionnaires and Quality of Life questionnaires.
- Secondary Outcome Measures
Name Time Method