Oral Misoprostol Before Endometrial Biopsy

Endometrial Biopsy Clinical Trial

Official title:

Oral Misoprostol Before Endometrial Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200226
• Other study ID #: HIC02.159
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 20, 2007
• Start date: February 2003
• Est. completion date: September 2007

Study information

• Verified date: September 2007
• Source: Memorial University of Newfoundland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Endometrial Biopsy

Intervention

Drug:
• misoprostol
misoprostol 400mcg 12 hrs prior to procedure
• vitamin B6
Vitamin B6 50 mg orally 12 hrs prior to procedure

Locations

Country	Name	City	State
Canada	Obstetrics and Gynecology Associates	Dartmouth	Nova Scotia
Canada	Women's Health Centre, Eastern Health	St. John's	Newfoundland and Labrador

Sponsors (1)

Lead Sponsor	Collaborator
Memorial University of Newfoundland

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain/discomfort of endometrial biopsy		during procedure
Secondary	ease of performing biopsy		during procedure
Secondary	success of obtaining biopsy		during procedure
Secondary	potential side effects		time study drug taken until procedure