Oral Misoprostol Before Endometrial Biopsy

September 20, 2007 updated by: Memorial University of Newfoundland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1E 5K9
        • Women's Health Centre, Eastern Health
    • Nova Scotia
      • Dartmouth, Nova Scotia, Canada, B2Y 4W2
        • Obstetrics and Gynecology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Vitamin B6
Drug: vitamin B6
Vitamin B6 50 mg orally 12 hrs prior to procedure
Active Comparator: 2
misoprostol
Drug: misoprostol
misoprostol 400mcg 12 hrs prior to procedure
Other Names:
  • Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain/discomfort of endometrial biopsy
Time Frame: during procedure
during procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
ease of performing biopsy
Time Frame: during procedure
during procedure
success of obtaining biopsy
Time Frame: during procedure
during procedure
potential side effects
Time Frame: time study drug taken until procedure
time study drug taken until procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial University of Newfoundland

Investigators

  • Principal Investigator: Joan MG Crane, MD, Faculty, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

September 21, 2007

Last Update Submitted That Met QC Criteria

September 20, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIC02.159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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