Viewing Study NCT00307775



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Study NCT ID: NCT00307775
Status: TERMINATED
Last Update Posted: 2012-05-01
First Post: 2006-03-27

Brief Title: Vaginal Estrogen for the Treatment of Faecal Incontinence in Women
Sponsor: London North West Healthcare NHS Trust
Organization: London North West Healthcare NHS Trust

Study Overview

Official Title: A Pilot Study to Examine the Efficacy of Vaginally Administered Oestradiol in the Treatment of Faecal Incontinence in Post Menopausal Women
Status: TERMINATED
Status Verified Date: 2007-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Lack of recruitment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will address the following questions

Does the use of oestrogen inserted vaginally with an applicator help with the symptoms of faecal bowel incontinence in women who are past the age of menopause
Do women find it easy to use
Is the treatment safe for the womb lining
Is there any systemic absorption of the treatment
Detailed Description: Faecal incontinence affects about 5 of women the most common cause is often cited by women as obstetric trauma However in clinical practice many women report that their symptoms of faecal incontinence begin around the same time as menopause A community survey examining the prevalence of faecal incontinence in menopausal women is in progress If a correlation is found between the onset of menopause and the development of faecal incontinence further investigation of effective treatment will be indicated

The investigators want to investigate whether vaginally administered oestradiol can alleviate or improve symptoms in women who have faecal incontinence after the menopause This is a pilot study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None