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Oral Misoprostol Before Endometrial Biopsy

This study has been completed.
Sponsor:
Information provided by:
Memorial University of Newfoundland
ClinicalTrials.gov Identifier:
NCT00200226
First received: September 12, 2005
Last updated: September 20, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Endometrial Biopsy
Drug: misoprostol
Drug: vitamin B6
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Oral Misoprostol Before Endometrial Biopsy

Resource links provided by NLM:


Further study details as provided by Memorial University of Newfoundland:

Primary Outcome Measures:
  • pain/discomfort of endometrial biopsy [ Time Frame: during procedure ]

Secondary Outcome 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 ]

Enrollment: 72
Study Start Date: February 2003
Study Completion Date: September 2007
Arms Assigned Interventions
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 Name: Cytotec

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200226

Locations
Canada, Newfoundland and Labrador
Women's Health Centre, Eastern Health
St. John's, Newfoundland and Labrador, Canada, A1E 5K9
Canada, Nova Scotia
Obstetrics and Gynecology Associates
Dartmouth, Nova Scotia, Canada, B2Y 4W2
Sponsors and Collaborators
Memorial University of Newfoundland
Investigators
Principal Investigator: Joan MG Crane, MD Faculty, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00200226     History of Changes
Other Study ID Numbers: HIC02.159
Study First Received: September 12, 2005
Last Updated: September 20, 2007
Health Authority: Canada: Health Canada

Keywords provided by Memorial University of Newfoundland:
pain/discomfort
cervical dilatation
side effects

Additional relevant MeSH terms:
Misoprostol
Pyridoxal
Pyridoxine
Vitamin B 6
Vitamin B Complex
Vitamins
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Growth Substances
Micronutrients
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014