A pilot study to examine the efficacy of vaginally administered oestradiol in the treatment of faecal incontinence in post menopausal women

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001975-37-GB

Enrollment

Registered

2005-11-10

Start date

2006-03-22

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Faecal Incontinence

Interventions

Trade Name: Vagifem Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026