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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00953641
Other study ID # 07-134
Secondary ID
Status Withdrawn
Phase Phase 3
First received August 26, 2008
Last updated August 11, 2012
Start date September 2011
Est. completion date September 2012

Study information

Verified date August 2012
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether using Misoprostol vaginally before an office endometrial biopsy is performed, will make it easier, more successful and less painful to do the procedure.

The investigators' hypothesis is that vaginal Misoprostol 12 hours prior to endometrial biopsy will increase the ease of performing office endometrial biopsy by reducing the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle.


Description:

Endometrial biopsy is a common gynecological office procedure performed to assist in the pathological diagnosis of abnormal vaginal bleeding. The procedure can be painful and it may be difficult to obtain an endometrial sample with a hard and closed cervix. Giving Misoprostol before the procedure may soften the cervix sufficiently to allow an easier and more successful test. This medication has been tested before hysteroscopy and in some patients it has been shown to be beneficial.

104 patients need to be recruited for this study. Participants will be divided according to pre-menopausal and post-menopausal status. Each of these groups will then be divided into a treatment arm (with Misoprostol) and a placebo arm. Participants will place a vaginal suppository containing either Misoprostol 400 ug or a placebo 12h or more before their appointment for the endometrial biopsy.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Female
Age group 35 Years and older
Eligibility Inclusion Criteria:

- Patients with abnormal uterine bleeding

- Age over 35 years

Exclusion Criteria:

- Pregnancy

- Allergy to or contraindication to prostaglandin use

- Active genital tract infections

- Bleeding disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Misoprostol
Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure
Placebo
Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy

Locations

Country Name City State
Canada Obstetrics and Gynecologic Consultants Saskatoon Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluating the ease of an endometrial biopsy by the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle 1 year No
Secondary Evaluating participants discomfort during the procedure, using a pain scale 1 year No
Secondary Success rate of passage of the pipelle 1 year No
Secondary Adverse effects from medications 1 year No
Secondary Complications of the procedure 1 year No
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