Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Vitamin B6
• Active Comparator: 2
  • misoprostol

Primary Measures

• pain/discomfort of endometrial biopsy
  • Time Frame: during procedure
    

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Memorial University of Newfoundland

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00200226

Study ID Number: HIC02.159

ClinicalTrials.gov Identifier: NCT00200226

Health Authority: Canada: Health Canada