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OpenTrials
Completed

NCT Number: NCT00200226

Oral Misoprostol Before Endometrial Biopsy

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.

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Key information

Conditions

Endometrial Biopsy

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Women's Health Centre, Eastern Health, St. John's, Newfoundland and Labrador, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

misoprostol 400mcg 12 hrs prior to procedure

Other names: Cytotec

Vitamin B6

Drug

Vitamin B6 50 mg orally 12 hrs prior to procedure

Primary outcomes

  1. pain/discomfort of endometrial biopsy

    Time frame: during procedure

Secondary outcomes

  1. ease of performing biopsy

    Time frame: during procedure

  2. success of obtaining biopsy

    Time frame: during procedure

  3. potential side effects

    Time frame: time study drug taken until procedure

Sponsors and collaborators

Lead sponsor

Memorial University of Newfoundland

Other

Registry information

Important dates

Study start
2003
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Sep 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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