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Oral Misoprostol Before Endometrial Biopsy

NCT ID: NCT00200226

Last Updated: 2007-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2007-09-30

Brief Summary

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An endometrial biopsy involves a thin tube being passed through the cervix (opening of the uterus) to obtain a sample of the lining of the uterus. Sometimes there may be discomfort with this procedure especially if the cervix is not dilated or opened. Previous research has suggested that taking a drug called misoprostol may help the cervix to start to dilate or open. This study will see if misoprostol will help open the cervix for an endometrial biopsy, to lessen the discomfort and make the biopsy easier to perform.

Detailed Description

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Conditions

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Endometrial Biopsy

Keywords

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pain/discomfort cervical dilatation side effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Vitamin B6

Group Type PLACEBO_COMPARATOR

vitamin B6

Intervention Type DRUG

Vitamin B6 50 mg orally 12 hrs prior to procedure

2

misoprostol

Group Type ACTIVE_COMPARATOR

misoprostol

Intervention Type DRUG

misoprostol 400mcg 12 hrs prior to procedure

Interventions

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misoprostol

misoprostol 400mcg 12 hrs prior to procedure

Intervention Type DRUG

vitamin B6

Vitamin B6 50 mg orally 12 hrs prior to procedure

Intervention Type DRUG

Other Intervention Names

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Cytotec

Eligibility Criteria

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Inclusion Criteria

* women 19 years and older
* planned endometrial biopsy

Exclusion Criteria

* known hypersensitivity or allery to prostaglandins
* seizure disorder
* liver disease
* known abnormal liver function tests
* pregnancy
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial University of Newfoundland

OTHER

Sponsor Role lead

Principal Investigators

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Joan MG Crane, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland

Locations

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Women's Health Centre, Eastern Health

St. John's, Newfoundland and Labrador, Canada

Site Status

Obstetrics and Gynecology Associates

Dartmouth, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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HIC02.159

Identifier Type: -

Identifier Source: org_study_id