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Oral Misoprostol Before Endometrial Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00200226
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 21, 2007
Sponsor:
Information provided by:
Memorial University of Newfoundland

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Endometrial Biopsy Drug: misoprostol Drug: vitamin B6 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Oral Misoprostol Before Endometrial Biopsy
Study Start Date : February 2003
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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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 Name: Cytotec


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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200226


Locations
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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
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Principal Investigator: Joan MG Crane, MD Faculty, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland
More Information
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ClinicalTrials.gov Identifier: NCT00200226    
Other Study ID Numbers: HIC02.159
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 21, 2007
Last Verified: September 2007
Keywords provided by Memorial University of Newfoundland:
pain/discomfort
cervical dilatation
side effects
Additional relevant MeSH terms:
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Vitamin B 6
Pyridoxal
Pyridoxine
Misoprostol
Vitamins
Micronutrients
Physiological Effects of Drugs
 Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Vitamin B Complex